Regeneron एक जैव-प्रौद्योगिकी कंपनी है जो गंभीर और उपेक्षित स्वास्थ्य समस्याओं के लिए दवाओं की खोज, विकास और व्यावसायीकरण करती है। इसका अनुसंधान एलर्जी, हृदय एवं चयापचय संबंधी रोगों, तंत्रिका-विज्ञान, कैंसर-विज्ञान, रक्त-विज्ञान, नेत्र-विज्ञान और दुर्लभ रोगों तक फैला हुआ है। जैविक अनुसंधान को उन्नत प्रौद्योगिकी के साथ जोड़कर Regeneron जटिल स्वास्थ्य देखभाल आवश्यकताओं को पूरा करने के उद्देश्य से जैविक और आनुवंशिक औषधियों पर काम करती है। रोगी देखभाल को आगे बढ़ाने के अपने व्यापक मिशन के तहत कंपनी स्वास्थ्य समानता, पर्यावरणीय जिम्मेदारी, वैज्ञानिक शिक्षा और नैतिक कॉर्पोरेट प्रथाओं पर भी जोर देती है।
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.
संयुक्त राज्य
न्यू जर्सी
न्यूयॉर्क$1,76,100 – $2,87,300 / वर्ष
हाइब्रिडपूर्णकालिकवरिष्ठआवश्यक भाषा: अंग्रेज़ीअनुपालनविवरण
- 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.
आवश्यकताएँ
- 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.
लाभ
- 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.