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Sr. Manager, Regulatory Affairs (Science & Biotech)
RTP, NC 27710
Recruited by: Lori Steiner | Principal and Owner | NeedLS See all my Jobs

  • Hiring Company: NeedLS
  • Industry: Science & Biotech
  • Compensation: to be determined
  • Expires: Apr 26, 2020
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Job Description

The Senior Manager RA will serve as the primary liaison with US regulatory authorities and is responsible for assisting with the development and implementation of regulatory strategy

• Regulatory life-cycle management for licensed products (e.g. preparation, coordination and submission of variations/supplements/annual reports, facility/product registrations)
• Timely management and preparation of high quality regulatory documents and submissions
• Act as the company's primary point of contact for FDA
• Establish effective working relationships with Regulatory Agencies and major regulatory consulting agents
• Management of Commercial requests to ensure content of promotional materials is compliant with applicable regulations
• Ensure regulatory applications comply with applicable regulations and guidance documents
• Coordinate the Health Authority response team
• Prepare and organize advice meetings with regulatory authorities
• Represent regulatory as member of Project Team(s) and assure RA input into designated projects
• Maintain regulatory expertise and serve as internal consultant on relevant regulations and guidelines, current regulatory environment and regulatory precedent
• Provide writing and review input into regulatory submission documents

Requirements:
• Advanced life science degree (MS, PhD)
• 8+ years of regulatory affairs experience required, preferably experience with biologics
• Experience in regulatory submissions and post-authorization life-cycle management
• Sound knowledge of FDA guidelines
• Proven direct interactions with FDA
• Excellent written and verbal communication skills