CMC Regulatory Affairs Associate
CMC Regulatory Affairs Associate
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
- Authoring and submitting PMA supplements (30-day Notice Real-Time Reviews 180-Day Supplements Annual Reports).
- Review/approval of engineering study protocols/reports and validation study protocols/reports.
- Review and approval of manufacturing changes for Class III implantable medical devices.
- May require an advanced degree and 3 to 5 years of direct experience in the field.
- Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations.
- Relies on extensive experience and judgment to plan and accomplish goals.
- Performs a variety of tasks.
- May lead and direct the work of others.
- A wide degree of creativity and latitude is expected.
- CMC (Chemistry Manufacturing Controls) background in completing clinical submissions.
- IND/IMPD submission background based on manufacturing batch records.
- Early Phase CMC knowledge a plus.
- French/ English speaking a plus.
- Experience Level 3-5 Years.
- Familiar with pharmaceutical master batch records and how to author CMC submissions for clinical studies.
- Technical writing skills.
- Familiar with typical manufacturing processes especially cell cultures.
- Familiar with microbial methodology.
- Familiar with ICH and country regulatory procedures for clinical trials.
- Able to work with electronic systems i.e. Microsoft and dossier publication systems.
- New manufacturing site in France due to acquiring new business . Contractor needed to complete 3 separate projects for CMC clinical/regulatory submissions. This was a previous commitment for completion from prior company.
Employment Type
Full Time
