Director/Senior Director Regulatory Project Management

Proclinical is currently recruiting for a Director of Regulatory Project Management with global pharmaceutical company located in Gaithersburg, MD. As the Director, you will contribute to regulatory submission strategy, working in close collaboration with the regulatory strategy and operational teams, as well as cross-functional teams across the organization (ie, Clinical, Nonclinical, and Quality) to identify submission risks and opportunities, define regulatory deliverables, and build and manage timelines to support regulatory filings through licensure and beyond.

Job Responsibilities:

• Define, manage, and track specific deliverables needed for regulatory submissions working with cross-functional teams, including INDs/CTAs, BLAs/MAAs (Modules 1-5), meeting requests, briefing packages, responses to health authority requests, etc.
• Develop and maintain detailed project timelines to track progress of regulatory submissions.
• Develop, execute, and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
• Ensure that overall regulatory project timelines are aligned cross-functionally and support the coordination and preparation of timely regulatory submissions.
• Provide regulatory guidance on procedural and documentation requirements defined by Health Authorities for specific regulatory deliverables.
• Maintain up-to-date working knowledge on relevant regulatory regulations, guidance, and the current regulatory environment.

Skills and Requirements:

• Bachelor's degree preferably in a scientific field; advanced degree desirable.
• A minimum of 12 years in the biotechnology industry with at least 10 years in Regulatory Affairs.
• Strong project management skills, including proficient use of MS Project and other tools (eg, Smartsheet).
• Strong leadership skills and ability to influence stakeholders.
• Background in regulatory affairs and project management within the biopharmaceutical industry; knowledge of the vaccine development regulatory process highly desirable.
• Experience managing at least 1 application through licensure (ie, BLA or NDA); including understanding of ICH CTD structure and content for clinical, nonclinical, and quality.
• Ability to work independently, within a group setting, and to interact effectively with different functional departments.
• Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.

If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at (+1) 646-367-2908 or n.walker@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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