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System One Services Associate Director, Regulatory Affairs CMC Facilities in Rockville, Maryland

Associate Director, Regulatory Affairs CMC FacilitiesRockville, MD

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Type:Direct-Hire

Category:Scientific & Clinical

Job ID:184117

Date Posted:01/24/2021

Job Title: Associate Director of CMC Regulatory Affairs

Location: Rockville MD

Type: Direct Hire

Growing Biotech Company is hiring an Associate Director of CMC Regulatory Affairs to join their team!

Responsibilities:

  • Implement and coordinate CMC regulatory activities with a primary focus on facilities to support the continued development of investigational vaccines through licensure and beyond.

  • Lead regulatory CMC activities, including planning, writing, and reviewing of Facilities sections/documents necessary to support regulatory submissions, including BLAs, meeting requests, briefing packages, and responses to queries from regulatory agencies.

  • Act as regulatory CMC Facilities representative on project teams to ensure that activities support and comply with the relevant regulatory requirements.

  • Maintain up-to-date working knowledge on relevant regulatory regulations, guidance, and the current regulatory environment.

Requirements:

  • MS or PhD in a biological science or related discipline

  • 10 years in the biotechnology industry with at least 8 years in regulatory affairs, CMC

  • Strong understanding and experience with current GMPs and regulatory expectations for investigational and commercial products.

  • Regulatory submissions experience with Module 3.2A

  • Biologics experience required, background in vaccine development with knowledge of the vaccine development process is highly desirable

  • Experience with CTD format and content.

Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

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