- Will support the global regulatory activities associated with the Chemistry, Manufacturing and Controls for clinical and commercial products.
- Will provide input into the product strategy and to the direction provided to commercial and clinical teams.
- Ensure that regulatory submissions are on time and of high quality.
- Must be a self-starter and have the ability to work with minimal direction.
- Experience in developing Briefing packages, IND, BLA and supporting regulatory meetings a plus.
- Manage the compilation, review and approval of the CMC data package for regulatory dossiers and documents in various phases of clinical development, global marketing applications, and post-approval life cycle activities
- Ensure the CMC content is complete, well-written, and conforms with established requirements for regulatory submissions
- Work closely with and coordinate project related activities with Regulatory Operations to ensure appropriate regulatory support of projects
- As a Regulatory CMC representative to assigned product teams, collaborate with project teams to implement company regulatory strategies. Communicate with internal and external customers to obtain required supporting documents and data for compilation of the CMC dossier in a timely manner that supports agreed upon project timelines. Ensure and/or enhance regulatory compliance with respect to filing requirements for assigned compounds throughout development and the commercial life cycle.
- Develop constructive relations with internal and external functional groups and partner/contract manufacturing sites
- Coordinate the task of drafting responses to CMC related questions from FDA or foreign health authorities per established process
- Evaluate proposed manufacturing changes for global impact to ongoing and existing filings, and provide a regulatory assessment and a submission strategy for optimal implementation of changes
- Research and interpret global CMC regulations and provide regulatory guidance to the project teams and functional groups
- Support the organization in maintaining a work environment that is focused on quality, and that fosters learning, open communication, collaboration, integration, and teamwork
- BA/BS degree in life sciences, chemistry, molecular biology, or related disciplines is required, advanced degree preferred
- 5-7 years of experience in Regulatory Affairs CMC in the pharmaceutical and/or biotechnology industry. Alternatively, 3 years pharmaceutical Regulatory CMC experience combined with 4+ years relevant pharmaceutical experience (e.g. Pharmaceutical Development, Analytical Development, Production, Quality Assurance or Quality Control). Manufacturing and/or Analytical experience is a plus
- Experience and knowledge in small molecule drugs is preferred but not required. Effective written and verbal communication skills, and abilities to present scientific data and author/edit technical documents are required
- Enjoy matrix environment and thrive in the challenges of multiple, fast-paced projects
- Job Types**: Full-time, Contract
- Regulatory Affairs: 5 years (Preferred)
*The position level is negotiable depending on experience and qualifications. These positions will report to the Chief Regulatory Officer CMC*
*Most of the work activities can be done in Home Office and minor travel required to client and regulatory meeting locations in US and Europe*