Regeneron jiddiy va tibbiy ehtiyojlari yetarlicha qondirilmagan kasalliklarga qarshi dori vositalarini kashf etadigan, ishlab chiqadigan va tijoratlashtiradigan biotexnologiya kompaniyasidir. Uning tadqiqotlari allergiya, yurak-qon tomir va metabolik kasalliklar, neyrofan, onkologiya, gematologiya, oftalmologiya hamda kam uchraydigan kasalliklarni qamrab oladi. Regeneron biologik tadqiqotlarni ilg‘or texnologiyalar bilan birlashtirib, murakkab tibbiy ehtiyojlarni qondirishga mo‘ljallangan biologik preparatlar va genetik dori vositalari ustida ishlaydi. Kompaniya bemorlarga ko‘rsatiladigan yordamni rivojlantirishga qaratilgan kengroq missiyasining bir qismi sifatida sog‘liqni saqlashdagi tenglik, atrof-muhitga mas’uliyat, ilmiy ta’lim va axloqiy korporativ amaliyotlarni ham ta’kidlaydi.
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.
Tavsif
- 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.
Talablar
- 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.
Imtiyozlar
- 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.