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Regulatory CMC Consultant

Employer
RegDev, Inc.
Location
Working from home.
Salary
Consultant Hourly Rate TBD.
Start date
Jan 13, 2025
View more categoriesView less categories
Discipline
Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Consultant

RegDev, Inc., is a consulting service organization with global clients investigating drugs, biologics, devices or combination products in multiple therapeutic areas.

We are searching for seasoned regulatory affairs consultants to integrate with clients requiring support e.g., to advise and execute regulatory CMC strategies.

Essential Duties and Responsibilities:

  • Extensive knowledge of CMC drug development science.
  • Interpret CMC global regulatory requirements, policies, guidance, and feedback from global health authorities and advise clients on strategic responses and implementation as well as draft responses.
  • Develop and execute on regulatory CMC strategies.
  • Lead preparation, review, and finalization of regulatory CMC documents for US INDs, NDAs/BLAs, and global CMC applications and responses to agency requests for information.
  • Conduct risk assessments, analyze risks, advise on mitigation strategies for clients.
  • Proactively remain up to date on regulatory landscape across a variety of compound types and formulation delivery systems.
  • Work with minimal supervisory oversight but know when to ask questions internally in order to ensure solid aligned advice to clients to enable their success.

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