<img height="1" width="1" alt="" style="display:none" src="https://www.facebook.com/tr?id=785769564843890&ev=PixelInitialized" />
Needls logo full vertical 80.jpg
Search for Jobs by Lori Steiner

Needls logo full vertical 80.jpg
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
Share this job:
Please ensure all fields are filled in and your resume is attached


Submit your information and resume instantly with Monster!

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

• 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