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Regulatory Affairs Leader
2 months ago
Radionetics Oncology, Inc. is a clinical stage biotechnology company focused on the discovery and development of novel radiopharmaceuticals for the treatment of a wide range of oncology indications. The company is poised to capitalize on the increasing demand for novel radiotherapeutics and is supported by leading life sciences investors.
Position Overview
The Vice President/Senior Vice President, Regulatory Affairs is the functional head leading regulatory activities on behalf of the Company. This key leadership role is responsible for performing all hands-on, tactical regulatory responsibilities and developing and communicating the Company's regulatory strategy to align with business objectives.
Key Responsibilities
- Develop and execute regulatory strategies to support the Company's product pipeline, ensuring timely execution and budgetary considerations.
- Act as the primary point of contact for regulatory authorities, including the FDA and other international regulatory agencies.
- Analyze data and evaluate the regulatory environment to drive alignment on priorities and ensure compliance with relevant regulations.
- Develop and drive regulatory risk management strategies and contingency plans to mitigate potential risks.
- Represent the company in regulatory affairs activities and discussions with internal and external stakeholders, including board members and external partners.
- Provide education, training, and interpretation of regulatory requirements to internal team members.
- Serve as a member of the senior leadership team and provide regulatory affairs leadership and guidance, participating in leadership discussions on broader corporate considerations.
- Lead, coach, mentor, guide, and evaluate direct and indirect reports, ensuring appropriate levels of accountability for decision making.
- Collaborate and communicate with cross-functional team members on regulatory affairs activities and filings, promoting a team-oriented approach.
- Maintain knowledge of regulatory requirements and best practices.
Requirements
- 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.
- Extensive hands-on regulatory experience leading nonclinical, clinical, and CMC strategy and documentation, with a track record of accomplishments in global regulatory affairs.
- Advanced knowledge of FDA and EMA regulations, international global clinical trial regulations, and ICH GCP, GMP, GLP guidelines and relevant requirements.
- 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.
Benefits
Radionetics Oncology, Inc. offers a competitive total compensation package, including bonus opportunity, equity, medical, dental, vision, life, short-term, and long-term disability insurance, 401(k) retirement plan, 4 weeks of paid time off (PTO) annually, and generous paid holidays.
Pay Range: $290,000 - $350,000
The company evaluates a variety of factors in determining individual pay decisions, including relevant education, experience, and skills, internal equity, complexity and responsibility of the role, and market demand relative to the position.
