The Regulatory Affairs Coordinator (called an Associate Product Development Champion [APDC] at Facet) is a Product Development Champion in training. The APDC provides guidance and support to Facet clients at all stages of regulated development with support from the Vice President, Research and Development, and other Facet product Development Champions.
The APDC will support the implementation of innovative regulatory strategies based on client input (stated goals, corporate objectives, and risk tolerance), background knowledge, education and experience, and through strong teamwork with Facet colleagues and partners. The APDC applies his/her knowledge and scientific experience to prepare high quality regulatory submission documents with the FDA reviewer in mind.
The APDC:
- Participates on US and/or global regulatory strategy and submission teams
- Serves as the clinical and/or CMC regulatory expert on project teams and within Facet, with oversight from PDC content experts
- Participates in FDA meeting activities, including support for the preparation of meeting materials, meeting rehearsals, and meeting attendance under the direction of a PDC
- Prepares regulatory submission content in subject matter area of expertise (clinical, nonclinical, and/or CMC)
- Establishes and maintains knowledge of regulatory environment, regulations and guidances
- Actively participates in service to the industry (e.g., industry memberships, conference presentations, publications)
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