Biotechnology Regulatory Affairs Executive
7 days ago
Monte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team as an Associate Director of Regulatory Affairs. This role will focus on oncology, immunology, and related therapeutic areas.
The successful candidate will be responsible for developing and implementing regulatory strategies to support the global development and approval of our innovative therapies.
Key Responsibilities:- Develop and execute the Regulatory strategy for assigned programs in alignment with the corporate goals.
- Oversee the preparation, submission, and maintenance of regulatory applications, including INDs, CTAs, marketing applications, Annual Reports, Orphan Drug Designation, Requests for Fast Track, and other regulatory documents.
- Lead and manage FDA and Health Authority interactions with FDA and global health authorities, including meetings, teleconferences, and written correspondence.
- Ensure compliance with global regulatory requirements and guidelines, including FDA, EMA, and other regulatory authorities.
- Represent Regulatory on cross-functional product teams and provide strategic regulatory guidance and support to achieve product development objectives.
- Bachelor's degree in health sciences or related field, or an advanced degree is preferred.
- Minimum of 12 years of experience in global regulatory affairs within the pharmaceutical or biotechnology industry.
- Hands-on experience in managing the preparation and timely submission of regulatory applications, such as US IND or CTA, is required.
- In-depth knowledge of global regulatory requirements, guidelines, and processes for drug development and approval.
- Strong computer skills, including knowledge of Excel, Word, PowerPoint, Outlook, and MS Project/Smartsheet.
Monte Rosa Therapeutics (MRT) is a clinical-stage biotechnology company developing highly selective molecular glue degrader (MGD) medicines for patients living with serious diseases in the areas of oncology, autoimmune and inflammatory diseases, and more.
We are committed to delivering innovative treatments that improve patient outcomes. Our team is passionate about advancing cutting-edge science and pushing the boundaries of what is possible.
Compensation and BenefitsWe offer a competitive salary range of $160,000 - $220,000 per year, depending on experience, plus benefits including medical, dental, and vision insurance, 401(k) matching, and generous paid time off.
Join us in shaping the future of biotechnology and making a meaningful impact on people's lives.
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