Job title: Snr. Regulatory Affairs Consultant
Job type: Interim / Project consulting
Emp type: Part-time
Industry: Biotechnology
Expertise: Pharmaceutical / CRO / Reagents / Personal Care
Pay interval: Hourly
Location: Raleigh-Durham, North Carolina
Job published: 13 Jul 2020
Job ID: 32049

Job Description



Senior Regulatory Affairs Consultant


Regulatory Affairs



Employment Type:



Raleigh-Durham, North Carolina/Remote


Company Background

Our client is a specialist life sciences consulting company that provides product development and regulatory consulting to Pharmaceutical, Biotechnology, Generics and Medical Device companies. The company has worked with the worlds leading companies, guiding them through their key product development and regulatory decision milestones, from proof of concept to commercialization and post marketing.


Job Summary

We are looking for a Senior Regulatory Affairs Consultant to support a gene therapy client as a RA Subject Matter Expert in the development and implementation of regulatory strategy and submissions. This is a critical hands-on position and is responsible for executing on all regulatory activities within the clients organization. The Senior Regulatory Affairs Consultant will work with cross-functional teams to manage all aspects of the regulatory submission processes, from authoring documents to final submission of documents to global health authorities.


What You’ll Do

  • Actively participate in cross-functional team(s) in the development, preparation and implementation of regulatory strategies to obtain, maintain and extend product development and registrations globally for gene therapies.
  • Actively works with other departments including Regulatory Operations to ensure appropriate planning, tracking, and alignment of contents and timelines for regulatory submissions.
  • Advise CMC, Clinical and non-clinical functions (Process Development, Analytical Development, Manufacturing and Quality Control) on the preparation and content of INDs, IMPDs, BLA and MAA dossiers to ensure timely delivery of final documents to be included in submissions.
  • Responsible for preparation/submission/maintenance of future BLA, MAA and IND/IMPD (including variations and amendments), Scientific Advice and FDA meetings for all of company’s pipeline products and support activities.
  • Preparing appropriate documentation, and participating in FDA Pre IND/IND, EoP2 meetings and any relevant meetings with US/Global regulatory authorities.
  • Serves as main contact with US Food and Drug Administration (FDA) and liaises with other country Regulatory Agencies as needed, directly or in coordination with local country representation; leads agency meeting preparation and attends key agency meetings to ensure full discussion of issues and opportunities and to track critical outcomes and commitments.
  • Identify potential regulatory risks to strategic/operational plans, and propose options to mitigate risk.
  • Prepare the team and lead negotiations with FDA, EMA and other health agencies.
  • Provide regulatory due diligence as required.
  • Monitor and update national and international registration requirements through reviews of publications, seminars, and direct communication with outside regulatory personnel.
  • Analyze FDA regulatory agency activities in areas concerning the Company's investigational products; advise senior management of potential and actual regulatory agency actions that could impact business.


Essential Skills/Qualification

  • Bachelor’s degree is required (advanced degree in a scientific discipline or relevant experience is preferred).
  • 10+ years in a Regulatory Affairs role within the biotechnology industry.
  • Strong understanding of advanced therapy product development within Cell and Gene Therapy and viral vectors, highly preferred.
  • Extensive and comprehensive knowledge of the drug development process.
  • Strong understanding and interpretation of GxP protocols and ICH, FDA, & EMA guidelines and regulations to ensure compliance.
  • Experience leading in Health Authority interactions and submission preparations (i.e PIND, EOP2, scientific advice meetings, etc.).
  • In-depth working knowledge of procedures, guidance and policies related to biologics development.
  • Experience with dossier compilation and submission, and regulatory experience across all product lifecycle stages.
  • Knowledge and proficiency in regulatory environments that include FDA, ICH and EMA.
  • Motivated, highly detail oriented, with the ability to work autonomously and in a multilevel, cross functional team setting to achieve client goals.
  • Excellent interpersonal and intercultural communication skills, both written and verbal.
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