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Regulatory Affairs Leader
2 months ago
Radionetics Oncology is a clinical-stage biotechnology company dedicated to the discovery and development of innovative radiopharmaceuticals for the treatment of various oncology indications. With a strong focus on novel radiotherapeutics, the company is poised to capitalize on the growing demand for effective cancer treatments.
Backed by prominent investors, including Frazier Life Sciences, 5AM Ventures, DCVC Bio, Crinetics Pharmaceuticals, and GordonMD Global Investments, Radionetics has established a strategic partnership with Eli Lilly. This collaboration underscores the company's commitment to advancing cutting-edge treatments for cancer patients.
Job SummaryThe Vice President/Senior Vice President, Regulatory Affairs, is a critical leadership role responsible for overseeing all regulatory activities on behalf of Radionetics Oncology. This individual will serve as the primary point of contact for regulatory agencies, ensuring timely and compliant execution of regulatory submissions. The successful candidate will possess extensive experience in regulatory affairs, with a proven track record of leading companies through successful FDA approvals.
Key Responsibilities- Develop and implement regulatory strategies to align with business objectives.
- Perform all hands-on and strategic regulatory affairs deliverables, including drafting and driving regulatory submissions.
- Act as the primary point of contact for regulatory authorities, such as the FDA and other agencies.
- Analyze data and evaluate the regulatory environment to drive alignment on priorities.
- Develop and drive regulatory risk management strategies and contingency plans.
- Represent the company in regulatory affairs activities and discussions with internal and external stakeholders.
- Provide education, training, and interpretation of regulatory requirements to internal team members.
- Lead, coach, mentor, guide, and evaluate direct and indirect reports to ensure appropriate levels of accountability.
- Maintain knowledge of regulatory requirements and best practices.
- Ph.D., Pharm.D., or other advanced degree in a scientific discipline.
- Minimum 15 years of related experience in regulatory affairs and/or related functions in drug development, demonstrating progressive levels of leadership within the pharmaceutical or biotechnology industry.
- A minimum of 5 years in a regulatory affairs leadership role.
- Extensive hands-on regulatory experience leading nonclinical, clinical, and CMC strategy and documentation.
- Advanced knowledge of FDA and EMA regulations, international global clinical trial regulations, and ICH GCP, GMP, GLP guidelines.
- Excellent interpersonal, organizational, and verbal and written communication skills.
- Ability to solve problems and work independently as well as collaboratively with team members.
- Exceptional computer and Microsoft 365 software program skills.
Radionetics Oncology offers a competitive total compensation package, including a bonus opportunity, equity, medical, dental, vision, life, short-term, and long-term disability insurance, 401(k) retirement plan, 4 weeks of paid time off annually, and generous paid holidays.
