Associate Director, Regulatory Affairs Strategy – Genetics Medicine

Regeneron

. Develop regulatory strategies for assigned programs in collaboration with senior management .

Posted 10/6/2026full-timeUnited StatesSenior💰 $176,100 - $287,300 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing regulatory strategies and managing regulatory activities for drug development programs, with a strong focus on compliance and communication with health authorities. Proficient in overseeing regulatory submissions and guiding multidisciplinary teams on clinical development requirements.

Highest-signal resume keywords

Regulatory Strategy DevelopmentIND or CTA FilingsBLA and MAA Content GuidanceRegulatory Communication AuthoringPharmaceutical Industry Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Guidance AnalysisClinical Protocol ReviewRegulatory Submission ManagementData Analysis and InterpretationScientific Writing

Soft Skills

Excellent Written CommunicationExcellent Verbal CommunicationTeam Collaboration

Certifications & Qualifications

MDPh.D.Pharm.D.

Industry Keywords

FDA LiaisonDrug DevelopmentBiotechnology ProductsRegulatory ComplianceClinical Development

About the role

Key responsibilities & impact

Develop regulatory strategies for assigned programs in collaboration with senior management
Analyze regulatory guidance and comparable drug development programs to support approval and development objectives
Liaise with the FDA and other health authorities
Manage regulatory activities associated with drug development programs
Participate in multidisciplinary project teams and provide regulatory guidance
Guide teams on regulatory requirements for clinical development and prepare and maintain IND or CTA filings
Oversee regulatory filings supporting assigned programs
Analyze clinical, preclinical, and manufacturing data and develop interpretations and conclusions
Review clinical protocols and clinical and preclinical study reports
Lead authoring of regulatory communications, including regulatory briefing packages
Ensure completeness and accuracy of regulatory submissions
Supervise regulatory staff planning, preparing, and submitting regulatory documentation
Manage planning, preparation, and submission of licensing applications
Guide teams on BLA and MAA content, format, style, architecture, and timing
Assist with scientific writing and application review
Manage timelines and budgets and provide progress updates to senior management
Monitor FDA and international guidance documents
Provide training on applicable requirements to scientific staff

Requirements

What you’ll need

MD, Ph.D., Pharm.D., or equivalent advanced degree; a relevant scientific discipline is strongly preferred
Minimum of 10 years of pharmaceutical industry experience
At least 5 years of regulatory experience
Research laboratory, process development, or manufacturing experience with biotechnology products highly desirable
Excellent written and verbal communication skills
Ability to work 4 days per week on site
Ability to travel up to 25% as required

Benefits

Comp & perks

Annual bonuses or other incentive plans
Equity awards
Pension or retirement benefits
401(k) company match
Health and wellness programs
Fitness centers
Medical, dental, vision, life, and disability insurance benefits
Paid time off
Family support benefits
Reasonable accommodation during the recruitment process where required