General Summary :
The individual will lead a team that will provide support to the Regulatory Affairs (CMC) Organization. This team’s primary responsibility will be to provide the technical content for the Chemistry, Manufacturing and Controls (CMC) sections of investigational drug applications (INDs, CTAs) and initial marketing applications, along with required supplements and amendments. Additional responsibilities include assisting the RA (CMC) group with the compilation of responses to the respective health authorities resulting from the noted filings, coordinating and synthesizing input from the required technical experts. This individual will represent this function on multi-disciplinary project teams. Must be detail-oriented with good oral and written communication skills. Must be able to multi-task and keep to the timelines established for the respective filings.
- Responsible for generating the technical content for the Chemistry, Manufacturing and Controls (CMC) documentation required for investigational new drug applications and their initial marketing applications, along with relevant supplements, amendments and health authority responses.
- Work collaboratively with the Biopharmaceutical Manufacturing and Development technical experts and the Regulatory Affairs CMC organization to implement regulatory filings.
- Coordinate the development of CMC filing related document templates with the Regulatory Affairs (CMC) Organization.
- Summarize technical reports and information in accordance with developed CMC document templates.
- Prepare and maintain an up-to-date project plan for each molecule to ensure CMC sections are delivered on time. The project plans will be based on the deliverables established by the product core teams and the filing schedule established by the Regulatory Affairs (CMC) organization.
- Participate as a member of multi-disciplinary teams to ensure project timelines impacting the availability of clinical and commercial supplies are met.
- Develop and supervise a multi-disciplinary team.
- Optimize the document work flow process.
- Assist manager with the development and maintenance of department budget.