Job Description

Summary:

The Director, Global Regulatory Affairs is responsible for contributing to the development and execution of regulatory strategies and managing regulatory submissions for company’s products. This role involves collaborating with cross-functional teams to ensure compliance with global regulatory standards and efficient management of regulatory activities throughout the product lifecycle .

Prefer someone with strong NDA submission experience

Key Duties & Responsibilities:

• Executes the defined regulatory strategy across the product portfolio.
• Oversees the day-to-day operations within the regulatory affairs function including oversight of submission coordination, submission publishing, advertising/promotional review, and process development/improvement initiatives.
• Submissions include IND's and NDA's (including 505(b)(2)), Annual Reports, amendments, Clinical Trial Applications, IND/NDA supplements, expedited program designation requests, and Pediatric Study Plans.
• Act as a primary regulatory point of contact for IND(s) , NDA(s) with the U.S. FDA.
• Collaborate with internal teams, such as R&D, Corporate Development, Quality Assurance, and Clinical, to ensure alignment of regulatory strategies with product development goal
• Identify regulatory risks and proactively work with cross-functional teams to develop mitigation strategies.
• Perform critical review and provide strategic input on submission documents to ensure compliance with regulatory requirements, health authority guidance, and company policie
• Oversee the preparation, review, and submission of regulatory submissions to health authorities.
• Coordinate, prepare, and contribute to the development of document packages for regulatory submissions, including INDs, NDAs, meeting requests, meeting briefing documents, responses to FDA comments and IRs, DSURs/Annual Reports, clinical study protocols, clinical study reports, and application amendments for assigned projects.
• Lead regulatory project timelines, ensuring that deliverables are met in a timely and efficient manner, and resolve issues that may arise during the product lifecycle.
• Manage and mentor Regulatory Affairs direct report(s), providing guidance on regulatory issues, career development, and project management.
• Stay up-to-date with evolving global regulations and industry trends, ensuring that the company remains compliant with current standards and best practice

Qualifications:

• Minimum of a bachelor’s degree in a science-related discipline; RAC certification is a plus.
• Global regulatory experience in ICH regions and Canada is a plus.
• 10 to 15 years of relevant regulatory experience in pharmaceutical pharmaceutical/biotechnology experience, with extensive knowledge of all aspects of the drug development
• Must demonstrate recognized leadership qualities in previous roles.
• Strong project management skills is a plus.
• Strong knowledge of current US and global regulations/guidelines
• Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands from a variety of R&D, Clinical, QA, Marketing, and Operations team
• Proven ability to communicate with executive management and external thought leaders.
• Demonstrated identification of key regulatory risks.

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