Description
MAJOR ACTIVITIES AND RESPONSIBILITIESReporting to the Associate Director of Regulatory Affairs, the Regulatory Affairs Manager will:
- Actively contribute to the development and implementation of regulatory strategy for assigned projects.
- Prepare, coordinate, manage or maintain simple and complex regulatory submissions (e.g., INDs, CTAs, amendments, safety reports, DSUR, annual reports, meeting packages, etc.) in accordance with applicable regulations; this includes ability to translate regulatory requirements into practical, workable submission plans; develop & maintain timelines; coordinate internal/external authoring/review/comment adjudication and finalization (submission and archival).
- Interface with external regulatory groups in the preparation/review/compilation/finalization/submission/posting of regulatory submissions.
- Act as liaison between Regulatory Affairs and other functional areas; represent Regulatory Affairs in cross-functional team meetings.
- Provide regulatory support for clinical operations activities
- Monitor company progress toward fulfillment of regulatory commitments.
- Initiate and/or contribute to local process improvements which have an impact on Regulatory Affairs, Quality Assurance or other departments.
- Review and communicate current & emerging regulatory requirements
- Author and review SOPs; ensure SOPs are in compliance with current regulatory requirements and provide regulatory support for corporate quality assurance efforts.
- Develop and maintain current regulatory knowledge.
Educational Requirements
- Bachelor's degree in a scientific discipline or equivalent.
Professional Work Experience
- Candidate must have at least 3 to 7 years of Regulatory experience in the pharma industry
- Must have a solid understanding of FDA regulations and ICH guidance's, as well as a comprehension of the drug development process.
- Experience with regulatory submissions, including INDs, international clinical trial applications, and marketing applications in Common Technical Document format, is essential.
- Able to handle multiple projects and exercise good judgment in prioritizing tasks.
- Demonstrated ability to work independently and within a group setting, and to interact effectively with various functional groups.
- Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
- High level of attention to detail, and be proficient with Microsoft Office applications, Adobe and document management templates.