Director, Regulatory Affairs Strategy

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Our client is currently seeking a Director, Regulatory Affairs Strategy who will beresponsible for contributing to the development and execution of regulatory strategies and managing regulatory submissions for companys products.Experience in NDA submission is highly preferred.
This job will have the following responsibilities: Key responsibilities of this role include, but are not limited to: Contribute to the regulatory strategy, development, and execution for companys products, including nonclinical and clinical regulatory strategy, INDs, marketing applications, and post-approval changes. Collaborate with internal teams, such as R&D, Corporate Development, Quality Assurance, and Clinical, to ensure alignment of regulatory strategies with product development goals. 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 policies. 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. Act as a primary regulatory point of contact for IND(s) with the U.S. FDA.
Qualifications & Requirements: Bachelors degree in Life Sciences, Pharmacy, or related field. Advanced degree (Masters, PhD, or PharmD) is preferred. 8-10 years of experience in Regulatory Affairs. Proven track record of successful regulatory submissions and approvals in relevant markets. Management and mentoring experience preferred. In-depth knowledge of regulatory requirements and guidelines (e.g. FDA, ICH). Experience with electronic submission systems (e.g. eCTD, SPL). Regulatory writing and liaison experience is required. Excellent written and verbal communication skills, with the ability to present complex information clearly. Strong problem-solving abilities and attention to detail.
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Location:
South San Francisco, CA, United States
Job Type:
FullTime
Category:
Management Occupations

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