Manager, Regulatory Affairs Strategy - Oncology
Regeneron · Warren, NJ · 1 mo ago
Hybrid$129k–$210k/yrFull-time
We need to output HTML fragment only, with headings for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. Must not repeat job title as heading. Must not put Job ID/requisition numbers as headings. Remove boilerplate, navigation, legal, EEO, etc. Must preserve all substantive info.
Let's parse the posting.
Content:
- Intro: "Build Our Future Together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager to join our Regulatory Affairs Strategy Oncology team. The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide."
- "When & Where Work Location: Tarrytown, NY or Warren, NJ 4 days per week on site"
- "Discover Your Role" then bullet list of responsibilities:
- Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator’s Brochure
- Assist in coordination and preparation for Agency meetings and associated briefing document preparation
- Leads and tracks queries and commitments with regulatory agencies, collaborates with subject matter experts to provide written responses to queries, provides periodic status updates regarding conditions/commitments
- Provide representation for study-level regulatory activities and participate in cross-functional departmental team projects and product development activities/meetings
- "This Role Requires Minimum MD, PhD or PharmD degree along with 2+ years of regulatory experience. We expect to see individuals have worked on filings, helped with developing regulatory related documents and engaged with external partners and authorities. If you bring good understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices. If you are interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred If you have a high attention to detail; ability to coordinate and prioritize assigned projects according to company goals You bring strong interpersonal skills both written and verbally"
- "Does this sound like you? Apply now to take your first step towards living the Regeneron Way!" (application instruction, remove)
- Then EEO boilerplate: remove.
- Then "Where required, we will provide reasonable accommodation..." remove.
- Then "Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter. Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location. As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications. For jobs in Canada: this posting is for an existing position. Salary Range (annually) $128,600.00 - $210,000.00"
We need to extract substantive info: location and schedule: "Work Location: Tarrytown, NY or Warren, NJ 4 days per week on site". That gives location and schedule (4 days per week on site). So we can have a Schedule section maybe? Actually schedule is "4 days per week on site". Could be under Schedule. Location maybe under About the role? But we have no explicit About the role heading; we could put a short paragraph about the role (the intro). The instructions: Use
for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. Must not repeat job title as heading. Must not put Job ID/requisition numbers as headings. Remove boilerplate, navigation, legal, EEO, etc. Must preserve all substantive info.
Let's parse the posting.
Content:
- Intro: "Build Our Future Together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager to join our Regulatory Affairs Strategy Oncology team. The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide."
- "When & Where Work Location: Tarrytown, NY or Warren, NJ 4 days per week on site"
- "Discover Your Role" then bullet list of responsibilities:
- Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator’s Brochure
- Assist in coordination and preparation for Agency meetings and associated briefing document preparation
- Leads and tracks queries and commitments with regulatory agencies, collaborates with subject matter experts to provide written responses to queries, provides periodic status updates regarding conditions/commitments
- Provide representation for study-level regulatory activities and participate in cross-functional departmental team projects and product development activities/meetings
- "This Role Requires Minimum MD, PhD or PharmD degree along with 2+ years of regulatory experience. We expect to see individuals have worked on filings, helped with developing regulatory related documents and engaged with external partners and authorities. If you bring good understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices. If you are interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred If you have a high attention to detail; ability to coordinate and prioritize assigned projects according to company goals You bring strong interpersonal skills both written and verbally"
- "Does this sound like you? Apply now to take your first step towards living the Regeneron Way!" (application instruction, remove)
- Then EEO boilerplate: remove.
- Then "Where required, we will provide reasonable accommodation..." remove.
- Then "Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter. Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location. As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications. For jobs in Canada: this posting is for an existing position. Salary Range (annually) $128,600.00 - $210,000.00"
We need to extract substantive info: location and schedule: "Work Location: Tarrytown, NY or Warren, NJ 4 days per week on site". That gives location and schedule (4 days per week on site). So we can have a Schedule section maybe? Actually schedule is "4 days per week on site". Could be under Schedule. Location maybe under About the role? But we have no explicit About the role heading; we could put a short paragraph about the role (the intro). The instructions: Use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we need to decide which sections to include based on content.
We have:
- About the role: could include the introductory paragraph describing the role, team, reporting, purpose.
- Responsibilities: the bullet list.
- Requirements: maybe the "Minimum MD, PhD or PharmD degree along with 2+ years of regulatory experience." plus expectations about filings, documents, external partners.
- Qualifications: maybe the understanding of US FDA, international guidance, etc. Could be overlapping with Requirements. But we need to avoid thin sections. Perhaps combine Requirements and Qualifications into one? But instructions say we can have sections only when posting has real specific content. We could have Requirements (degree + experience) and Qualifications (FDA guidance, CRO interaction, attention to detail, interpersonal skills). Or we could merge them into a single "Requirements" section. However they list both as possible headings; we can choose to include only those with substantive content. We have content for both.
- Skills: maybe the interpersonal skills etc. But we already have that in Qualifications. Could treat Skills as separate for interpersonal skills, attention to detail, ability to coordinate/prioritize. But we might avoid duplication.
- Benefits: we have description of total rewards package: annual bonuses, equity awards, pension/retirement benefits, 401(k) match, health and wellness programs, fitness centers, insurance benefits, paid time off, family support benefits. That's substantive.
- Pay: we have salary range: $128,600 - $210,000 annually.
- Schedule: we have "4 days per week on site". Also location: Tarrytown, NY or Warren, NJ. Could be under Schedule or maybe a separate "Location" but not in list. Could put location in About the role or Schedule. Since schedule heading exists, we can include location there as well.
We must not include placeholder text like "commensurate with experience". We have actual numbers.
We must not include boilerplate like EEO, accommodation, background checks, etc. Remove those.
We must not include application instructions like "Apply now". Remove.
We must not include links? The benefits link maybe can be kept? It's part of benefits description. Might be okay to keep as part of benefits paragraph. But it's a URL; it's substantive? Might be considered extra but not required to remove. Probably okay to keep.
We must output only HTML fragment, no /, no markdown fences.
Thus produce something like:
About the role
About the role
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager to join our Regulatory Affairs Strategy Oncology team. The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
Responsibilities
- Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator’s Brochure
- Assist in coordination and preparation for Agency meetings and associated briefing document preparation
- Leads and tracks queries and commitments with regulatory agencies, collaborates with subject matter experts to provide written responses to queries, provides periodic status updates regarding conditions/commitments
- Provide representation for study-level regulatory activities and participate in cross-functional departmental team projects and product development activities/meetings
Requirements
Minimum MD, PhD or PharmD degree along with 2+ years of regulatory experience. Experience working on filings, developing regulatory-related documents, and engaging with external partners and authorities.
Qualifications
Strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices. Experience interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activation is preferred. High attention to detail; ability to coordinate and prioritize assigned projects according to company goals. Strong interpersonal skills both written and verbally.
Benefits
Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.
Pay
Salary Range (annually): $128,600.00 - $210,000.00
Schedule
Work Location: Tarrytown, NY or Warren, NJ. Expected schedule: 4 days per week on site.
Check that we didn't repeat job title as heading. Good. We removed boilerplate, EEO, accommodation, background checks, etc. We kept all substantive info. Check for any missing info: The intro also mentions "When & Where Work Location: Tarrytown, NY or Warren, NJ 4 days per week on site". We placed location and schedule in Schedule section. Good. We didn't include "Discover Your Role" heading; we used Responsibilities. We didn't include "Does this sound like you? Apply now..." removed. We didn't include "For jobs in Canada: this posting is for an existing position." That's minor metadata; we could drop it. It's not substantive for the role; we can drop. We didn't include "As part of the recruitment process, certain background checks may be conducted..." removed. We didn't include "Where required, we will provide reasonable accommodation..." removed. We didn't include "Where necessary, we disclose salary ranges..." we already have Pay. We didn't include "In some countries, collective bargaining agreements (CBAs) may apply..." maybe could be mentioned under Benefits or Pay but it's not specific; we can drop. We didn't include "For other locations, additional information will be provided during the recruitment process." drop. We didn't include "If you have any questions, please speak with your recruiter." drop. We didn't include "Please be advised that at Regeneron, we believe we do our best work when we are together." drop. All good