Sr. Manager, Regulatory Affairs
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Accentuate is working with a local Pharmaceutical company focused primarily on Respiratory Disease. We have been asked to assist in finding candidates for this Sr. Manager in Regulatory Affairs. These are Direct Hire positions.
Responsibilities:
Overall responsibility for the management of US Regulatory Affairs matters and maintenance of NDAs relating to the approved pharmaceutical products portfolio, in support of the business goals. This includes:
- Review and approval of promotional materials in accordance with labeling including oversight of filing of 2253s
- Review and approval of packaging materials in accordance with labeling, and approval of artwork through partner electronic portal
- Maintenance of NDAs including coordinating compilation and submission of ad hoc reports, aggregate reports, annual updates, DSCSA reports, and other post marketing requirements
- Coordinating responses to any Deficiency letters from US FDA
Requirements:
- Bachelor of Science in a scientific or healthcare discipline
- 5 to 10 years’ experience in post-approval Regulatory Affairs and NDA maintenance in a commercial environment.
- A broad understanding of operational Regulatory Affairs, as it pertains to the maintenance of pharmaceutical product NDAs in the USA.
