Regeneron este o companie de biotehnologie care descoperă, dezvoltă și comercializează medicamente pentru afecțiuni grave și insuficient deservite. Cercetările sale acoperă alergiile, bolile cardiovasculare și metabolice, neuroștiința, oncologia, hematologia, oftalmologia și bolile rare. Prin combinarea cercetării biologice cu tehnologia avansată, Regeneron dezvoltă medicamente biologice și genetice concepute pentru a răspunde unor nevoi complexe de sănătate. Compania pune, de asemenea, accent pe echitatea în sănătate, responsabilitatea față de mediu, educația științifică și practicile corporative etice, ca parte a misiunii sale mai ample de a îmbunătăți îngrijirea pacienților.
Associate Director, Regulatory Affairs Strategy – Genetics Medicine (Hybrid)
Lead regulatory strategy for Regeneron’s pharmaceutical and genetics medicine programs, including FDA engagement, submissions, and global compliance. Coordinate multidisciplinary teams and guide development activities across the product lifecycle.
Descriere
- Shape regulatory strategies for assigned programs with senior leadership.
- Evaluate regulatory guidance and comparable development programs to support approvals and development plans.
- Serve as a liaison with the FDA and other health authorities.
- Oversee regulatory activities across drug development programs.
- Contribute regulatory expertise to multidisciplinary project teams.
- Advise teams on clinical development requirements and manage IND or CTA filings.
- Direct regulatory filings for assigned programs.
- Interpret clinical, preclinical, and manufacturing data and develop evidence-based conclusions.
- Review clinical protocols and clinical and preclinical study reports.
- Lead regulatory communications, including briefing package preparation.
- Verify the completeness and accuracy of regulatory submissions.
- Supervise staff responsible for preparing and submitting regulatory documents.
- Coordinate the planning, preparation, and submission of licensing applications.
- Advise teams on BLA and MAA content, structure, style, format, and timing.
- Support scientific writing and application reviews.
- Track timelines and budgets while reporting progress to senior management.
- Monitor FDA and international regulatory guidance.
- Train scientific staff on applicable regulatory requirements.
Cerințe
- Advanced degree such as an MD, Ph.D., Pharm.D., or equivalent; a relevant scientific field is strongly preferred.
- At least 10 years of experience in the pharmaceutical industry.
- At least 5 years of regulatory affairs experience.
- Experience in research laboratories, process development, or biotechnology product manufacturing is highly desirable.
- Strong written and verbal communication abilities.
- Availability to work onsite four days per week.
- Willingness to travel up to 25% as needed.
Beneficii
- Annual bonuses and other incentive opportunities.
- Equity award programs.
- Pension or retirement benefits.
- Company matching contributions to a 401(k) plan.
- Health and wellness initiatives.
- Access to fitness centers.
- Medical, dental, vision, life, and disability insurance.
- Paid time off.
- Family support programs.
- Reasonable recruitment-process accommodations where required.