Director of Regulatory Affairs Strategy
This position is with a rapidly growing pharmaceutical company known for its commitment to advancing transformative therapies. In this role you will have a unique opportunity to lead regulatory strategies for innovative pharmaceutical products, making a meaningful impact on patient health. You'll collaborate with cross-functional teams and engage directly with regulatory agencies, influencing critical decisions in drug development.
Key Responsibilities:
- Oversee daily regulatory activities for projects involving compounds in development or on the market, including submission strategies and regulatory intelligence.
- Collaborate with Project Teams to develop regulatory and product strategies, including drafting labeling and NDA package inserts.
- Work with various departments to formulate and execute effective Regulatory Strategies, assessing and communicating regulatory risks and opportunities.
- Manage submissions and maintenance of INDs, NDAs, MAAs, and related documents.
- Support due diligence activities for potential product acquisitions or partnerships.
- Serve as the primary regulatory contact with agencies, including the FDA, and represent the regulatory function in key meetings.
- Monitor the regulatory landscape and communicate updates to stakeholders.
- Advise on regulatory requirements to support business strategies, providing expert guidance on scientific and medical issues.
Qualifications:
- Bachelor's degree in life sciences or related field; advanced degree preferred.
- Minimum 10 years of experience in pharmaceutical regulatory drug development.
- Proven track record in new chemical entity and line extension filings.
- Experience interacting with global health authorities and conducting due diligence.
- Strong knowledge of global pharmaceutical regulations and excellent communication skills.
