Job Description

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.

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