BioSpace
Director CMC Regulatory Affairs
Leads the Chemistry, Manufacturing, and Controls (CMC) & Combination Products (CP) Internal Medicine team. The candidate will develop and execute global regulatory strategies for the assigned drug/device portfolio, oversee regulatory affairs staff, outside contractors, project teams, and lead activities with the Health Authority.
Typical Day
Oversee the assigned CMC/CP Regulatory Affairs team, driving global regulatory strategies and operational direction for the assigned portfolio.
Lead the preparation, review, and submission of regulatory documents (meeting packages, scientific advice, BLAs, MAAs, BPDRs, supplements) to regulatory authorities.
Provide scientific and regulatory inputs for the assigned portfolio to facilitate development and marketing of drugs and/or biologics.
Oversee and direct interactions with global regulatory authorities, including meetings, information request responses, and inspections.
Direct and provide advice on compliance activities (change controls, deviations) for the assigned portfolio, evaluating regulatory impacts and submission requirements for clinical and commercial filings.
Develop and implement department objectives and work plans, delegate responsibility effectively, and prioritize team workloads.
Provide leadership by contributing to departmental strategy, organizational goals, and policy development.
Guide team members to address complex and unprecedented program challenges, ensuring timely resolution.
Participate in cross‑functional groups and working groups to improve practices and establish new processes.
Qualifications
Proven track record of supporting biological products and/or small molecule drugs through development and approval is a distinct advantage.
Strong understanding of current CMC / CP worldwide regulations.
Successful leadership in delivering CMC/CP sections of marketing authorizations, clinical trial applications, and post‑approval submissions for biological, combination, and/or small molecule drugs.
Previous experience with device regulatory requirements and development processes for combination products is an advantage.
Human Factors experience is a plus.
Experience in dealings with the FDA and other regulatory authorities.
Experience managing and developing staff members.
Requirements
A bachelor’s degree with a minimum of 10 years of pharmaceutical/biotech industry experience, including at least 8 years of relevant CMC experience; or a master’s degree with 8+ years of experience; or a PhD with 3+ years of experience.
At least 3 years of applicable managerial experience.
We have an inclusive culture that provides comprehensive benefits, which vary by location. For additional information about benefits, please visit the employer’s benefits portal.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business.
Salary Range (annually): $172,200.00 - $286,900.00
#J-18808-Ljbffr
Typical Day
Oversee the assigned CMC/CP Regulatory Affairs team, driving global regulatory strategies and operational direction for the assigned portfolio.
Lead the preparation, review, and submission of regulatory documents (meeting packages, scientific advice, BLAs, MAAs, BPDRs, supplements) to regulatory authorities.
Provide scientific and regulatory inputs for the assigned portfolio to facilitate development and marketing of drugs and/or biologics.
Oversee and direct interactions with global regulatory authorities, including meetings, information request responses, and inspections.
Direct and provide advice on compliance activities (change controls, deviations) for the assigned portfolio, evaluating regulatory impacts and submission requirements for clinical and commercial filings.
Develop and implement department objectives and work plans, delegate responsibility effectively, and prioritize team workloads.
Provide leadership by contributing to departmental strategy, organizational goals, and policy development.
Guide team members to address complex and unprecedented program challenges, ensuring timely resolution.
Participate in cross‑functional groups and working groups to improve practices and establish new processes.
Qualifications
Proven track record of supporting biological products and/or small molecule drugs through development and approval is a distinct advantage.
Strong understanding of current CMC / CP worldwide regulations.
Successful leadership in delivering CMC/CP sections of marketing authorizations, clinical trial applications, and post‑approval submissions for biological, combination, and/or small molecule drugs.
Previous experience with device regulatory requirements and development processes for combination products is an advantage.
Human Factors experience is a plus.
Experience in dealings with the FDA and other regulatory authorities.
Experience managing and developing staff members.
Requirements
A bachelor’s degree with a minimum of 10 years of pharmaceutical/biotech industry experience, including at least 8 years of relevant CMC experience; or a master’s degree with 8+ years of experience; or a PhD with 3+ years of experience.
At least 3 years of applicable managerial experience.
We have an inclusive culture that provides comprehensive benefits, which vary by location. For additional information about benefits, please visit the employer’s benefits portal.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business.
Salary Range (annually): $172,200.00 - $286,900.00
#J-18808-Ljbffr