Sr. Regulatory Affairs Specialist (50573819) Coventry, Rhode Island

This position will have advanced responsibilities in support of the Regulatory Affairs department goals and objectives.

PRINCIPAL ACCOUNTABILITIES:
- Manage regulatory affairs drug product development projects through entire lifecycle - from initiation through commercialization.
- Review drug product labeling components for NDAs and ANDAs.
- Compose, review, and submit to the FDA original INDs, NDAs, ANDAs, supplements, amendments, annual reports, and periodic adverse event reports in both paper and electronic CTD format. Review all chemistry, manufacturing, and controls (CMC) documentation related to submissions.
- Complete electronic publishing of regulatory submissions for submission to the FDA and other regulatory authorities.
- Serve as the regulatory representative on cross-functional teams supporting products throughout the stages of development and commercialization. Ensure regulatory and cross-functional project strategies and submission timelines are in alignment.
- Develop and track regulatory project timelines that incorporate all submission requirements including CMC, clinical, and labeling functions.
- Communicate regulatory requirements and expectations to various contract organizations, including travel for on-site meetings as necessary.
- Serve as the Rhodes Pharmaceuticals representative for industry groups. As needed, travel to face-to-face meetings and communicate decision points and meeting outcomes to senior management.
- Evaluate proposed changes to approved products for potential regulatory impact. Gather required data as needed to defend regulatory filing strategy.
- Contact FDA and other regulatory authorities for review status updates for pending applications and supplements.
- Author and review departmental SOPs, as well as any additional SOPs that may impact regulatory affairs.
- Monitor various websites and publications to gather regulatory intelligence on proposed product pipeline projects and any associated information.
- Perform due diligence audits of applications proposed for transfer from external partners. Review all documentation submitted throughout the lifecycle of the application and request any additional information prior to authorization of the transfer.

Educational Requirements

- BS in science or related field with 10 or more years of applicable US Generic Drug Regulatory Affairs experience.
- Advanced degree preferred.
- US Regulatory Affairs Professional Certification is desirable.

Required Experience & Technical Requirements

- Experience filing electronic CTD submissions in the US
- Experience with regulatory timeline development and document tracking
- Excellent verbal and written communication skills
- Availability and willingness to travel as necessary
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