Senior Scientist, Product Lead CMC Regulatory Affairs

We need to output HTML fragment with sections: About the role? Actually we need to use headings for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections if posting has real specific content. We need to extract content: The posting includes: - About Innovative Medicine (some description). Could map to "About the role" maybe role"? The instruction: use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can use "About the role" heading for the description about Innovative Medicine and the role overview. - Responsibilities: list of duties (the bullet points after "will be responsible for the following:"). - Requirements: maybe combine Qualifications and Required? The posting has "Qualifications Education ..." and "Required ..." plus "Required Skills Preferred Skills:" list. We need to separate sections: Qualifications (education, experience), Skills (list of preferred skills). Requirements maybe could be the "Required" bullet list? But we can treat "Qualifications" as education and experience; "Skills" as the list of preferred skills; maybe "Requirements" not needed if we have Qualifications and Skills. However we need to include sections only if content present. We have Qualifications content (education, experience). We have Skills content (list). We have Benefits content (detailed). We have Pay content (anticipated base pay range). We have Schedule? Not mentioned explicitly; maybe hybrid role location but not schedule. No schedule details. So omit Schedule. We also need to include location? Not a heading; could be in a short paragraph under About the role maybe. But we should preserve all substantive information. The location info: "This position is a hybrid role and can be located in Titusville, NJ; Raritan, NJ; Spring House, NJ; or Horsham, PA." That's substantive; we should include it perhaps in About the role paragraph. Also there is "Job Function Discovery & Pre-Clinical/Clinical Development Job Sub Function Regulatory Science Job Category Scientific/Technology All Job Posting Locations: Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America". That's location duplication; we can incorporate location in a short paragraph. We need to remove boilerplate: EEO, accommodation request, etc. Also remove "Please note that this role is available across multiple countries..." etc. Also remove "Learn more at jnj.com" etc? The instruction: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The "Learn more at jnj.com" maybe considered navigation? It's a link to learn more about Innovative Medicine; might be considered substantive? It's a link; but we can keep as part of prose? It's not essential but maybe keep as it's part of description. However it's a generic link; could be considered boilerplate? Not sure. Safer to keep it as it's part of the "About Innovative Medicine" paragraph. But we can drop the "Learn more at https://www.jnj.com/innovative-medicine" as it's just a link; but it's substantive? Might be considered navigation. I'd remove it to be safe. Also remove "As guided by Our Credo..." etc? That's generic corporate fluff; maybe considered boilerplate? It's not specific to role; but it's part of company description. Might be considered boilerplate; but we need to preserve ALL substantive information; not sure if that's substantive. It's generic mission statement. Could be considered boilerplate. I'd remove it to keep focused. We need to output only HTML fragment, no markdown fences. Let's craft:

About the role

Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Scientist, Product Lead CMC Regulatory Affairs - Synthetics, New Modalities. This is a hybrid role located in Titusville, NJ; Raritan, NJ; Spring House, NJ; or Horsham, PA. The role involves driving scientific strategy and regulatory activities for synthetic modalities and new modalities.

But we need to preserve all substantive info from the "About Innovative Medicine" paragraph: "Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way." That's substantive; we should include that. Thus About the role paragraph can combine both. Now Responsibilities: list each duty as

. We need to capture all responsibilities listed after "will be responsible for the following:" up to before "Qualifications". Let's extract them: - Drive scientific strategy and critical decision-making through integration of disease biology, pharmacology, biomarkers, human genetics, and clinical data. - Contribute to the development of global CMC (Chemistry, Manufacturing, and Controls) regulatory strategies and dossier plans according to scientific/risk-based principles in collaboration with other Global CMC Regulatory Affairs (CMC RA) personnel. - May participate as the Regulatory CMC Lead on CMC Teams and represent CMC RA by providing regulatory expertise on the CMC Core Team and Global Regulatory Team (GRT) to facilitate successful product development globally and to provide input on team recommendations. - Support global regulatory filings for mainly development compounds, and potentially also marketed products, in collaboration with other CMC RA senior personnel. - Prepare regulatory dossiers for submission to Health Authorities under supervision. - Coordinates, compiles, and manages CMC country specific documents required as part of the approval process for global submissions. - Assist in developing and preparing CMC Health Authority responses as needed according to the proposed strategy. - May participate in selected initiatives within CMC RA/GRA. - Drive a culture of continuous improvement to ensure compliance with Johnson & Johnson standards, regulatory requirements and expectations. Communicate critical issues to Management. - May contribute to the development/implementation of global CMC regulatory strategies and dossier plans for development compounds (and marketed products). - Ensure the CMC regulatory strategy is in alignment with the strategies of global Regulatory Affairs, the therapeutic area, commercial, regional functions and the Quality Target Product Profile (QTPP). - Assure connectivity to the overall global regulatory strategy through partnership and communication with Therapeutic Area Regulatory Affairs (Global Regulatory Leader) or other senior level CMC RA personnel. - Provide input to and assists in the preparation of dossiers for submission to Health Authorities (NDA/BLA /MAA/IND/CTA and post approval variations). - Assist in providing accurate regulatory assessments of CMC changes to teams for execution of regulatory planning and implementation. - Escalate issues to CMC RA Management that affect registration, regulatory compliance and continued lifecycle management of the product. - Assist in execution or development of contingency plans for issues that affect registration, regulatory compliance, and continued lifecycle management of the product. - Provide CMC Regulatory support to health authority inspections. We need to ensure each as

. Some sentences have multiple clauses; keep as is. Now Qualifications: Education and Required. Education: "A minimum of a Bachelor’s degree in Biological, Pharmaceutical, Chemical or Engineering Sciences or a related scientific discipline is required. Advanced degree (Master’s, PharmD, Ph.D.) preferred." Required: list bullet points after "Required". Let's extract: - A minimum of 4 years of related pharmaceutical or health care industry experience, inclusive of post graduate education. - Solid understanding of biology, chemistry and/or engineering, relevant to the pharmaceutical industry. - Prior drug development, analytical development, or manufacturing experience. - Experience interacting with Health Authorities independently or under the supervision of CMC Regulatory Affairs staff. - Working knowledge of global Health Authority laws, regulations and guidances. - The ability to present and defend CMC management-approved regulatory strategy and opinion to project teams. - The ability to demonstrate model behavior that understands what the priorities are and encourages others to drive for results. - The ability to communicate regulatory requirements to stakeholders cross-functionally and cross-company. - Excellent verbal and written communication skills. - Strong attention to detail. We can combine Education and Required under Qualifications heading, maybe separate subheadings? But only allowed headings are the given list; we can just put all under Qualifications as a

• list, but we need to differentiate education vs experience? Could just list all items. Better: Provide a

  for education sentence, then a

  for required experience/skills. Now Skills: "Preferred Skills: Analytical Reasoning, Coaching, Communication, Compliance Risk, Consulting, Controls Compliance, Corporate Governance, Critical Thinking, Data Governance, Drug Discovery Development, Healthcare Trends, Public Policies, Regulatory Compliance, Regulatory Development, Relationship Building, Scientific Research, Technical Writing, Technologically Savvy" We can list as
  • each skill. Now Benefits: detailed list. We'll put under

    Benefits

    then
    • each benefit. We need to preserve all specifics: Vacation –120 hours per calendar year, Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year, Holiday pay, including Floating Holidays –13 days per calendar year, Work, Personal and Family Time - up to 40 hours per calendar year, Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child, Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year, Caregiver Leave – 80 hours in a 52-week rolling period, 10 days Volunteer Leave – 32 hours per calendar year, Military Spouse Time-Off – 80 hours per calendar year. Also note there is a line: "For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits" That's a link; could be considered navigation; maybe remove. Now Pay: "The anticipated base pay range for this position is : $109,000.00 - $174,800.00". Also there is "Additional Description For Pay Transparency". We'll include Pay section with that range. Schedule: none. Now we need to ensure we don't repeat job title as heading. Already not. We need to output only HTML fragment. Let's construct:

      About the role

      Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Scientist, Product Lead CMC Regulatory Affairs - Synthetics, New Modalities. This is a hybrid role located in Titusville, NJ; Raritan, NJ; Spring House, NJ; or Horsham, PA. Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

      Responsibilities

      • Drive scientific strategy and critical decision-making through integration of disease biology, pharmacology, biomarkers, human genetics, and clinical data.
      • Contribute to the development of global CMC (Chemistry, Manufacturing, and Controls) regulatory strategies and dossier plans according to scientific/risk-based principles in collaboration with other Global CMC Regulatory Affairs (CMC RA) personnel.
      • May participate as the Regulatory CMC Lead on CMC Teams and represent CMC RA by providing regulatory expertise on the CMC Core Team and Global Regulatory Team (GRT) to facilitate successful product development globally and to provide input on team recommendations.
      • Support global regulatory filings for mainly development compounds, and potentially also marketed products