Job Opportunity
Job Title: Manager Regulatory Submissions
Location: Northern CA
Industry: Pharmaceutical
Type: Full-time
Description: Assume a key role responsible for preparing regulatory submissions, including INDs, ANDAs, and NDAs, and also provide counsel on submission strategies for a broad base of pharmaceutical products. Our client is a dynamic and growing pharmaceutical company developing a broad base of pharmaceutical products.
Contributions: You will be responsible for regulatory submissions, submission strategies, acting as the companies’ primary liaison with the FDA for regulatory submissions, and developing / maintaining a training program on electronic regulatory submissions. In addition, you will select and work with vendors to support eCTD readiness, and will provide guidance to CROs on eCTD and other submission related issues.
Capabilities: Utilize your experience with electronic submissions (in eCTD format), a strong working knowledge of FDA / ICH / EU guidelines, and also bring an in-depth understanding of software systems for electronic submissions (such as CoreDossier, Insight, eCTDXpress, or equivalent) to a key strategic position.
An exciting opportunity to work with an experienced team, in a collaborative work environment, and leading the company to fully electronic submissions. A key leadership role with excellent career growth prospects within the company.
Contact: infomrb@mrbellevue.com
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