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.