(REMOTE) Regulatory Project Manager
Responsible for overseeing nonclinical, clinical, and labeling regulatory elements of our proprietary products and development initiatives. Additional responsibilities include managing the Target Product Profile (TPP), Company Core Data Sheet (CCDS), definition of claims, regulatory strategy (clinical and non-clinical), defining dossier Table of Contents, and development and management of submissions.
- Work with project teams to create, implement, execute regulatory strategic plans, and help create the nonclinical and clinical study plans necessary for regulatory approval.
- Coordinating the creation, evaluation, and submission of the nonclinical and clinical regulatory dossier modules (IND/CTA/NDA/MAA filings).
- Create and implement performance standards and deadlines for regulatory projects in collaboration with the CMC Lead.
- Strategic execution for submissions of product registration documents to health authorities.
- Interact cross functionally to prepare documents for regulatory submissions.
- 8+ years experience in Regulatory Affairs in the pharmaceutical/biologic industry while holding responsibility for preparing and submitting electronic regulatory applications.
- Regulatory Affairs Certification (RAC) preferred.
- Working knowledge of the CFRs and the ability to understand and interpret domestic and international governmental regulations/guidelines and apply them so that regulatory requirements are met.
- Bachelor's Degree in scientific field required. Master's degree preferred.