Associate Director, Global Regulatory Labeling and Ad Promo
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Use - for any list of duties/requirements/benefits, and
for prose. Do NOT repeat the job title as a heading. Do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short
or drop it. Preserve ALL substantive information; do NOT invent or summarize away detail. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. IMPORTANT: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. Prefer a few substantive sections over many thin ones. Output ONLY the HTML fragment — no /, no markdown code fences.
Thus we need to parse the posting and extract sections.
Content:
- Intro paragraph: "At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team."
That's about the company/mission. Could be "About the role" or "About the company". The instruction says use headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we can use "About the role" for that intro.
- Then "What You’ll Do The Associate Director, Global Regulatory Labeling and Ad Promo will be initially responsible for product labeling and non-promotional strategies to support organizational goals while maintaining regulatory compliance. This Associate Director will work on cross-functional teams, partnering with key internal/external team members."
That's a prose description of role; could be part of About the role or separate? Probably part of About the role. We'll include it in About the role paragraph.
- Then "Responsibilities" heading with bullet list:
Lead the development, review, and maintenance of U.S. prescribing information, patient labeling, Medication Guides, Instructions for Use (IFU), primary and secondary (carton) labeling, and promotional labeling
Provide regulatory guidance to ensure compliance with regulations on product labeling throughout development, registration, launch, and post-approval lifecycle management
Collaborate with clinical, CMC, medical, safety, device engineering, technical operations, and commercial teams to ensure labeling content accurately reflects available data and regulatory requirements
Support labeling negotiations with FDA and manage implementation of approved labeling updates
Evaluate proposed safety, efficacy, and scientific claims for consistency with approved labeling
Serve as a core member of the Medical, Legal, Regulatory (MLR) review process. Collaborate with MLR process owner
Ensure compliance with FDA regulations, including:
FD&C Act requirements
FDA advertising and promotion regulations
OPDP guidance and enforcement trends
PhRMA Code requirements
Company policies and procedures
Provide regulatory recommendations to support compliant and effective non promotional and promotional communications
Monitor evolving FDA guidance, enforcement actions, warning letters, and industry best practices related to labeling and promotional review
Contribute to the development and maintenance of SOPs, policies, and governance processes
We need to format as
- items. Some items have sub-bullets (like Ensure compliance with FDA regulations, including: then list). We could treat the sub-bullets as nested
. But instruction: Use - for any list of duties/requirements/benefits. It doesn't forbid nesting. We'll do nested.
- Then "Required Qualifications" heading with bullet list:
Advanced degree (such as PhD, PharmD, MS, MBA) with at least 5 years of relevant drug development experience including product labeling or a bachelor’s degree with 10+ years
Established working knowledge of regulatory guidelines and regulations (US and international); with a particular focus on product labeling and advertising promotion
Demonstrated deep knowledge of the integrated drug development process
Demonstrated ability to find solutions and alternatives through teamwork resulting in positive business outcomes
Demonstrated ability to assess and manage risk in a highly regulated environment
Strong written, spoken and presentation communication
Strong desire to grow career in the pharmaceutical industry, willingness to learn, and enthusiastically embrace new opportunities
Travel expected (10-15%)
We need to decide if "Travel expected (10-15%)" is a qualification? It's more like a job detail. Could be placed under "Requirements" or maybe separate "Travel". But we can include it as a qualification bullet.
- Then "Education" heading: "Bachelor’s degree with 10+ years of experience or Advanced degree (such as PhD, PharmD, MS, MBA) with 5+ years of experience". This seems duplicate of Required Qualifications. Might be redundant. We could combine or keep as Education section. The instruction: prefer a few substantive sections over many thin ones. Since Education repeats qualifications, maybe we can omit Education section and incorporate into Required Qualifications. But we must preserve ALL substantive information; not invent or summarize away detail. If we drop Education heading, we lose that specific line. However the Required Qualifications already includes similar: "Advanced degree ... with at least 5 years ... or a bachelor’s degree with 10+ years". The Education line is essentially same. So we could keep it as part of Required Qualifications; not duplicate. The instruction says preserve ALL substantive information; we can keep the info but not duplicate headings. So we can merge.
- Then "Salary Range $155,000—$190,000 USD". That's Pay section. We must include Pay section only if posting actually states them. Yes, it does. So we need a Pay section with that info. Use
for prose. Could be
Salary Range: $155,000—$190,000 USD
. Also note the note: "For Full Time Roles: This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity." That's also substantive; we should preserve. So include that as part of Pay section.
- Then benefits: "We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us."
That's Benefits section. Use - for list.
- Then EEO and E-Verify boilerplate: we must remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate. So drop those paragraphs.
Thus sections: About the role (intro + What You’ll Do), Responsibilities, Required Qualifications (including Education), Pay, Benefits. Possibly also Skills? Not explicitly listed; we could skip.
We must not create Schedule section because not mentioned.
Now format.
We need to output only HTML fragment, no /. Use
for each section heading.
Let's craft:
About the role
At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team. The Associate Director, Global Regulatory Labeling and Ad Promo will be initially responsible for product labeling and non-promotional strategies to support organizational goals while maintaining regulatory compliance. This Associate Director will work on cross-functional teams, partnering with key internal/external team members.
Responsibilities
- Lead the development, review, and maintenance of U.S. prescribing information, patient labeling, Medication Guides, Instructions for Use (IFU), primary and secondary (carton) labeling, and promotional labeling
- Provide regulatory guidance to ensure compliance with regulations on product labeling throughout development, registration, launch, and post-approval lifecycle management
- Collaborate with clinical, CMC, medical, safety, device engineering, technical operations, and commercial teams to ensure labeling content accurately reflects available data and regulatory requirements
- Support labeling negotiations with FDA and manage implementation of approved labeling updates
- Evaluate proposed safety, efficacy, and scientific claims for consistency with approved labeling
- Serve as a core member of the Medical, Legal, Regulatory (MLR) review process. Collaborate with MLR process owner
- Ensure compliance with FDA regulations, including:
- FD&C Act requirements
- FDA advertising and promotion regulations
- OPDP guidance and enforcement trends
- PhRMA Code requirements
- Company policies and procedures
- Provide regulatory recommendations to support compliant and effective non promotional and promotional communications
- Monitor evolving FDA guidance, enforcement actions, warning letters, and industry best practices related to labeling and promotional review
- Contribute to the development and maintenance of SOPs, policies, and governance processes
Required Qualifications
- Advanced degree (such as PhD, PharmD, MS, MBA) with at least 5 years of relevant drug development experience including product labeling or a bachelor’s degree with 10+ years
- Established working knowledge of regulatory guidelines and regulations (US and international); with a particular focus on product labeling and advertising promotion
- Demonstrated deep knowledge of the integrated drug development process
- Demonstrated ability to find solutions and alternatives through teamwork resulting in positive business outcomes
- Demonstrated ability to assess and manage risk in a highly regulated environment
- Strong written, spoken and presentation communication
- Strong desire to grow career in the pharmaceutical industry, willingness to learn, and enthusiastically embrace new opportunities
- Travel expected (10-15%)
Pay
Salary Range: $155,000—$190,000 USD. For Full Time Roles: This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity.
Benefits
- Comprehensive health coverage
- Flexible time off
- Paid holidays
- Year-end shutdown
- Monthly wellness stipend
- Generous 401(k) match
- Tuition reimbursement
- Commuter benefits
- Disability and life insurance
- Annual bonus opportunities
- Equity grants
for prose. Do NOT repeat the job title as a heading. Do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short
or drop it. Preserve ALL substantive information; do NOT invent or summarize away detail. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. IMPORTANT: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. Prefer a few substantive sections over many thin ones. Output ONLY the HTML fragment — no /, no markdown code fences. Thus we need to parse the posting and extract sections. Content: - Intro paragraph: "At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team." That's about the company/mission. Could be "About the role" or "About the company". The instruction says use headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we can use "About the role" for that intro. - Then "What You’ll Do The Associate Director, Global Regulatory Labeling and Ad Promo will be initially responsible for product labeling and non-promotional strategies to support organizational goals while maintaining regulatory compliance. This Associate Director will work on cross-functional teams, partnering with key internal/external team members." That's a prose description of role; could be part of About the role or separate? Probably part of About the role. We'll include it in About the role paragraph. - Then "Responsibilities" heading with bullet list: Lead the development, review, and maintenance of U.S. prescribing information, patient labeling, Medication Guides, Instructions for Use (IFU), primary and secondary (carton) labeling, and promotional labeling Provide regulatory guidance to ensure compliance with regulations on product labeling throughout development, registration, launch, and post-approval lifecycle management Collaborate with clinical, CMC, medical, safety, device engineering, technical operations, and commercial teams to ensure labeling content accurately reflects available data and regulatory requirements Support labeling negotiations with FDA and manage implementation of approved labeling updates Evaluate proposed safety, efficacy, and scientific claims for consistency with approved labeling Serve as a core member of the Medical, Legal, Regulatory (MLR) review process. Collaborate with MLR process owner Ensure compliance with FDA regulations, including: FD&C Act requirements FDA advertising and promotion regulations OPDP guidance and enforcement trends PhRMA Code requirements Company policies and procedures Provide regulatory recommendations to support compliant and effective non promotional and promotional communications Monitor evolving FDA guidance, enforcement actions, warning letters, and industry best practices related to labeling and promotional review Contribute to the development and maintenance of SOPs, policies, and governance processes We need to format as
- items. Some items have sub-bullets (like Ensure compliance with FDA regulations, including: then list). We could treat the sub-bullets as nested
- . But instruction: Use
- for any list of duties/requirements/benefits. It doesn't forbid nesting. We'll do nested.
- Then "Required Qualifications" heading with bullet list:
Advanced degree (such as PhD, PharmD, MS, MBA) with at least 5 years of relevant drug development experience including product labeling or a bachelor’s degree with 10+ years
Established working knowledge of regulatory guidelines and regulations (US and international); with a particular focus on product labeling and advertising promotion
Demonstrated deep knowledge of the integrated drug development process
Demonstrated ability to find solutions and alternatives through teamwork resulting in positive business outcomes
Demonstrated ability to assess and manage risk in a highly regulated environment
Strong written, spoken and presentation communication
Strong desire to grow career in the pharmaceutical industry, willingness to learn, and enthusiastically embrace new opportunities
Travel expected (10-15%)
We need to decide if "Travel expected (10-15%)" is a qualification? It's more like a job detail. Could be placed under "Requirements" or maybe separate "Travel". But we can include it as a qualification bullet.
- Then "Education" heading: "Bachelor’s degree with 10+ years of experience or Advanced degree (such as PhD, PharmD, MS, MBA) with 5+ years of experience". This seems duplicate of Required Qualifications. Might be redundant. We could combine or keep as Education section. The instruction: prefer a few substantive sections over many thin ones. Since Education repeats qualifications, maybe we can omit Education section and incorporate into Required Qualifications. But we must preserve ALL substantive information; not invent or summarize away detail. If we drop Education heading, we lose that specific line. However the Required Qualifications already includes similar: "Advanced degree ... with at least 5 years ... or a bachelor’s degree with 10+ years". The Education line is essentially same. So we could keep it as part of Required Qualifications; not duplicate. The instruction says preserve ALL substantive information; we can keep the info but not duplicate headings. So we can merge.
- Then "Salary Range $155,000—$190,000 USD". That's Pay section. We must include Pay section only if posting actually states them. Yes, it does. So we need a Pay section with that info. Use
for prose. Could be
Salary Range: $155,000—$190,000 USD
. Also note the note: "For Full Time Roles: This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity." That's also substantive; we should preserve. So include that as part of Pay section. - Then benefits: "We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us." That's Benefits section. Use- for list.
- Then EEO and E-Verify boilerplate: we must remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate. So drop those paragraphs.
Thus sections: About the role (intro + What You’ll Do), Responsibilities, Required Qualifications (including Education), Pay, Benefits. Possibly also Skills? Not explicitly listed; we could skip.
We must not create Schedule section because not mentioned.
Now format.
We need to output only HTML fragment, no /. Use
for each section heading. Let's craft:
About the role
At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team. The Associate Director, Global Regulatory Labeling and Ad Promo will be initially responsible for product labeling and non-promotional strategies to support organizational goals while maintaining regulatory compliance. This Associate Director will work on cross-functional teams, partnering with key internal/external team members.
Responsibilities
- Lead the development, review, and maintenance of U.S. prescribing information, patient labeling, Medication Guides, Instructions for Use (IFU), primary and secondary (carton) labeling, and promotional labeling
- Provide regulatory guidance to ensure compliance with regulations on product labeling throughout development, registration, launch, and post-approval lifecycle management
- Collaborate with clinical, CMC, medical, safety, device engineering, technical operations, and commercial teams to ensure labeling content accurately reflects available data and regulatory requirements
- Support labeling negotiations with FDA and manage implementation of approved labeling updates
- Evaluate proposed safety, efficacy, and scientific claims for consistency with approved labeling
- Serve as a core member of the Medical, Legal, Regulatory (MLR) review process. Collaborate with MLR process owner
- Ensure compliance with FDA regulations, including:
- FD&C Act requirements
- FDA advertising and promotion regulations
- OPDP guidance and enforcement trends
- PhRMA Code requirements
- Company policies and procedures
- Provide regulatory recommendations to support compliant and effective non promotional and promotional communications
- Monitor evolving FDA guidance, enforcement actions, warning letters, and industry best practices related to labeling and promotional review
- Contribute to the development and maintenance of SOPs, policies, and governance processes
Required Qualifications
- Advanced degree (such as PhD, PharmD, MS, MBA) with at least 5 years of relevant drug development experience including product labeling or a bachelor’s degree with 10+ years
- Established working knowledge of regulatory guidelines and regulations (US and international); with a particular focus on product labeling and advertising promotion
- Demonstrated deep knowledge of the integrated drug development process
- Demonstrated ability to find solutions and alternatives through teamwork resulting in positive business outcomes
- Demonstrated ability to assess and manage risk in a highly regulated environment
- Strong written, spoken and presentation communication
- Strong desire to grow career in the pharmaceutical industry, willingness to learn, and enthusiastically embrace new opportunities
- Travel expected (10-15%)
Pay
Salary Range: $155,000—$190,000 USD. For Full Time Roles: This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity.
Benefits
- Comprehensive health coverage
- Flexible time off
- Paid holidays
- Year-end shutdown
- Monthly wellness stipend
- Generous 401(k) match
- Tuition reimbursement
- Commuter benefits
- Disability and life insurance
- Annual bonus opportunities
- Equity grants
- for list.
- Then EEO and E-Verify boilerplate: we must remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate. So drop those paragraphs.
Thus sections: About the role (intro + What You’ll Do), Responsibilities, Required Qualifications (including Education), Pay, Benefits. Possibly also Skills? Not explicitly listed; we could skip.
We must not create Schedule section because not mentioned.
Now format.
We need to output only HTML fragment, no /. Use
- for any list of duties/requirements/benefits. It doesn't forbid nesting. We'll do nested.
- Then "Required Qualifications" heading with bullet list:
Advanced degree (such as PhD, PharmD, MS, MBA) with at least 5 years of relevant drug development experience including product labeling or a bachelor’s degree with 10+ years
Established working knowledge of regulatory guidelines and regulations (US and international); with a particular focus on product labeling and advertising promotion
Demonstrated deep knowledge of the integrated drug development process
Demonstrated ability to find solutions and alternatives through teamwork resulting in positive business outcomes
Demonstrated ability to assess and manage risk in a highly regulated environment
Strong written, spoken and presentation communication
Strong desire to grow career in the pharmaceutical industry, willingness to learn, and enthusiastically embrace new opportunities
Travel expected (10-15%)
We need to decide if "Travel expected (10-15%)" is a qualification? It's more like a job detail. Could be placed under "Requirements" or maybe separate "Travel". But we can include it as a qualification bullet.
- Then "Education" heading: "Bachelor’s degree with 10+ years of experience or Advanced degree (such as PhD, PharmD, MS, MBA) with 5+ years of experience". This seems duplicate of Required Qualifications. Might be redundant. We could combine or keep as Education section. The instruction: prefer a few substantive sections over many thin ones. Since Education repeats qualifications, maybe we can omit Education section and incorporate into Required Qualifications. But we must preserve ALL substantive information; not invent or summarize away detail. If we drop Education heading, we lose that specific line. However the Required Qualifications already includes similar: "Advanced degree ... with at least 5 years ... or a bachelor’s degree with 10+ years". The Education line is essentially same. So we could keep it as part of Required Qualifications; not duplicate. The instruction says preserve ALL substantive information; we can keep the info but not duplicate headings. So we can merge.
- Then "Salary Range $155,000—$190,000 USD". That's Pay section. We must include Pay section only if posting actually states them. Yes, it does. So we need a Pay section with that info. Use