Associate Director, Regulatory Affairs Strategy - General Medicine

Regeneron Pharmaceuticals, Inc.; Kentucky; Hybrid; USD 180,000 - 293,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Retirement benefits

401(k) company match

Health and wellness programs

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc. seeks an Associate Director to join Regulatory Affairs Strategy in the United States.

The role develops regulatory strategies, liaises with the FDA, and guides cross-functional teams through IND/CTA filings and regulatory submissions to support development programs. Based in Tarrytown, NY or Warren, NJ with four days on site, you will lead regulatory activities, supervise staff, manage timelines and budgets, and stay current with FDA guidance to keep programs

Qualifications

• An MD, Ph.D., Pharm.D., or equivalent advanced degree; a relevant scientific discipline is strongly preferred.
• A minimum of 10 years of pharmaceutical industry experience, at least 5 of which should include regulatory experience.
• Research laboratory, process development or manufacturing experience with biotechnology products highly desirable.

Responsibilities

• Develop regulatory strategies for assigned programs in collaboration with Regeneron's Regulatory senior management and by analysis of guidances.
• Liaison responsible for communication with FDA and other health authorities for assigned programs.
• Management of all regulatory activities associated with Regeneron drug development programs.
• Participate in multidisciplinary project teams to provide regulatory guidance and communicate regulatory goals.
• Provide guidance to multidisciplinary teams on the regulatory requirements to support clinical development, including preparation and maintenance of IND or CTA filings.
• Oversee development of all regulatory filings in support of program.
• In collaboration with team, perform analyses of data and develop interpretations.
• Perform reviews of clinical protocols and study reports for regulatory compliance.
• Lead multidisciplinary teams in authoring regulatory communications such as regulatory briefing packages.
• Accountable for ensuring completeness and accuracy of information in regulatory submissions.
• Supervises regulatory staff with planning, preparation and submission of all regulatory documentation.
• Management of the planning, preparation and submission of licensing applications.
• Provide guidance on content, format, style, architecture and timing of BLA and MAA.
• Assist with the scientific writing and review of application.
• Evaluate conformance with regulatory requirements, clarity, and completeness.
• Manage timelines/budgets with project management and provide progress updates.

Skills

Regulatory strategy

FDA liaison

Regulatory submissions

Cross-functional collaboration

Regulatory documentation

Education

MD/PhD/PharmD or equivalent

Job description

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director to join our Regulatory Affairs Strategy team. This position in Regulatory Affairs involves the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development to all aspects of Regeneron's quality, preclinical and clinical drug development programs, policies, and procedures, so that Development teams are able to meet all objectives within specified timelines and so that the necessary state of compliance is maintained relative to all regulatory commitments/requirements. 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 25% Travel may be required

Discover Your Role

• Develop regulatory strategies for assigned programs in collaboration with Regeneron's Regulatory senior management and by analysis of guidances and assessment of drug developed for similar indication to obtain approval of activities in support of Regeneron’s development and marketing objectives within specified timelines
• Liaison responsible for communication with FDA and other health authorities for assigned programs
• Management of all regulatory activities associated with Regeneron drug development programs.
• Participate in multidisciplinary project teams to provide regulatory guidance and communicate regulatory goals.
• Provide guidance to multidisciplinary teams on the regulatory requirements to support clinical development, include preparation and maintenance of IND or CTA filings.
• Oversee development of all regulatory filings in support of program.
• In collaboration with team, perform/manage critical analyses of data (clinical, preclinical and manufacturing), independently develop interpretations and conclusions.
• Perform reviews of clinical protocols and of clinical and preclinical study reports with respect to clarity, completeness, and regulatory requirements.
• Lead multidisciplinary teams in the authoring of regulatory communications such as regulatory briefing packages.
• Accountable for ensuring the completeness and accuracy of information provided in regulatory submissions.
• Supervises regulatory staff with the planning, preparation and submission of all regulatory documentation.
• Management of the planning, preparation and submission of licensing applications.
• Provide guidance/instruction to multidisciplinary teams on the content, format, style architecture and timing of a Biologics Licensing Application (BLA) and MAA.
• Assist with the scientific writing and review of application.
• Evaluate conformance with the regulatory requirements, clarity, and completeness.
• Manage timelines/budgets with project management as appropriate and provide progress updates to senior management
• Continually monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs.
• Provide training on applicable requirements for scientific staff as required.

This Role Requires

• An MD, Ph.D., Pharm.D., or equivalent advanced degree; a relevant scientific discipline is strongly preferred.
• A minimum of 10 years of pharmaceutical industry experience, at least 5 of which should include regulatory experience.
• Research laboratory, process development or manufacturing experience with biotechnology products highly desirable.
• Must possess excellent written and verbal communication skills.

We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Please be advised that at Regeneron, we believe we do our best work when we are together.

Salary Range (annually) $179,600.00 - $293,000.00

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

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
• 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.