17 days ago
Our client is a biopharmaceutical company based in Seattle, which has multiple Phase II and III clinical-stage development programs is currently hiring for a Regulatory Affairs specialist professional to join the team.
In this position, you would be responsible for coordinating the preparation, compilation and review of CMC filings in support of commercial applications, regional requirements and company policies and procedures.
Main responsibilities include:
- To create & compile content of CMC documentation to regulatory agencies to ensure that standards for regulatory submissions are met
- Assist with the preparation of information and related activities for CMC meetings with health authorities
- Coordinates the preparation of CMC submissions through editing and approval of final documents including review for quality in a timely manner
- To have an up-to-date knowledge of regulatory requirements and to ultimately communicate any changes in regulatory information to director and project teams
- To support submission process to assist in the overall efficiency of the regulatory submissions
- Manage regulatory CMC activities within time and budget for approved project plans
- BS in a scientific discipline (plus training in regulatory affairs specific training)
- MS degree in Drug Regulatory Affairs or Regulatory Science (highly preferred)
- 3+ years’+ in the pharmaceutical industry with at least 1 year in a CMC Regulatory focused role
- You must have a good understanding of CMC regulatory requirements (including FDA and ICH guidelines)
If this opportunity interests you, please get in touch today so that we can provide a full job description and explore in more detail!