A biotechnology company that focuses on developing innovative treatments for orphan and rare diseases is seeking a Regulatory Affairs Manager to join their team in Princeton, New Jersey.
The Manager of Regulatory Affairs role will report to the Director, Regulatory Affairs and is accountable for the preparation, coordination, and management of simple and complex regulatory submissions. The incumbent will work independently and within a group setting to act as liaison between Regulatory Affairs and other functional areas including external CROs, partners, and consultants in the planning, organizing, and preparing of regulatory documents for submission to governmental regulatory agencies.
- 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 coordinate identified regulatory requirements into reliable submission plans; develop & maintain timelines; coordinate internal/external authoring/review/comment adjudication and finalization (submission and archival).
- Provide review and comment during document (e.g., IB, protocol, ICFs, DSURs, annual reports, etc.) review, including consideration of regulatory/ICH guidance/requirements pertaining to document strategic purpose and content.
- Interface with external regulatory groups (e.g., CRO, partner, consultants, etc.) in the preparation/review/compilation/finalization/submission/posting of regulatory submissions.
- Regulatory Affairs activities with other functional areas as required including representation Regulatory Affairs in cross-functional team meetings.
- Provide regulatory support for clinical operations activities (e.g., review of essential documents, and development and review of consent forms, etc.).
- Monitor company progress toward fulfillment of regulatory commitments.
- Initiate and/or contribute to local process improvements which have an impact on Regulatory Affairs, including the authoring and review of standard operating procedures (SOPs).
- Remain current on regulatory requirements (e.g., Domestic and International) supporting the regulatory strategy and clinical operations related activities.).
- Bachelor's or Master's degree in a scientific discipline or equivalent.
- Regulatory Affairs Certification is preferred
- Candidate must possess at least 5 to 7 years of Regulatory experience in the pharmaceutical or biotechnology industry, with demonstrated increasing expertise and responsibility.
- Experience working with innovative products and implementation of creative development strategies are highly desirable.
- 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.
- Solid understanding of FDA regulations and ICH guidance's and experience with regulatory submissions, including INDs, international clinical trial applications, and marketing applications in Common Technical Document format.
- Excellent written and effective verbal communication skills, proficient in project management, is flexible, and able to work in a fast paced environment.
- 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.
- Domestic and international travel required.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please send your CV to Mike Froggatt on [click here] or upload to our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.