Associate Director, Regulatory Affairs Strategy - Genetics Medicine

Regulatory Toolkit; Village of Tarrytown (NY); On-site; USD 176,000 - 287,000; Full time

Job summary

Regeneron seeks an Associate Director to join Regulatory Affairs Strategy in NY/NJ to guide regulatory plans for programs and interface with FDA and other authorities. You will lead submissions, analyze data, and coordinate activities across development teams to meet timelines.

Role requires an MD/Ph.D./Pharm.D. or equivalent, with at least 10 years in pharma and 5+ in regulatory. Excellent communication and biotech experience highly valued.

Qualifications

• MD/Ph.D./Pharm.D. or equivalent advanced degree.
• Minimum of 10 years of pharmaceutical industry experience, at least 5 in regulatory.
• Biotechnology experience in research, development or manufacturing desirable.
• Excellent written and verbal communication skills.

Responsibilities

• 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.
• Independently develop interpretations of data and reviews of protocols and study reports for regulatory compliance.
• Lead multidisciplinary teams in authoring regulatory communications such as briefing packages.
• Accountable for completeness and accuracy of information in regulatory submissions.
• Supervise regulatory staff with planning, preparation and submission of regulatory documentation.
• Manage licensing application planning and submission.
• Provide guidance on content and timing of BLA and MAA submissions.
• Assist with scientific writing and review of applications for regulatory conformance.
• Manage timelines and budgets and provide progress updates to senior management.
• Monitor FDA and international guidance; train staff on applicable requirements.

Education

MD/Ph.D./Pharm.D. or equivalent advanced degree

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.

Does this sound like you? 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.

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.

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)

$176,100.00 - $287,300.00