ProClinical is currently seeking a Manager of Regulatory Affairs on behalf of an exciting growing biopharmaceutical company developing therapies for rare / orphan diseases. This biopharma company have entities being developed at the clinical stage across all phases, as well as a product currently being marketed in the EU with plans to enter the US market in Winter 2017. The Manager of Regulatory Affairs, Rare Disease will report to the Director, Regulatory Affairs and is accountable for the preparation, coordination and management of regulatory submissions supporting the Rare Disease program. The incumbent will work within a group setting to act coordinate assigned Regulatory Affairs activities with other functional areas including external CROs, partners, and consultants in the planning, organizing, and preparing of regulatory documents as required for submission to governmental regulatory agencies. This individual will have a 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. The ideal candidate will have excellent written and effective verbal communication skills, proficient in project management, is flexible, and able to work in a fast-paced environment.
- Actively contribute to the operational implementation of regulatory strategy for assigned projects.
- Prepare, coordinate, manage or maintain 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 preparation, 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.
- Coordinate 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.).
- 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.).
Skills and Requirements:
- Bachelor's or Master's degree in a scientific discipline or equivalent.
- Candidate must have at least 5 to 7 years of Regulatory Affairs experience in the pharmaceutical or biotechnology industry, experience with clinical development of biologics in rare disease indications is preferred.
- 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 biologics drug development process.
- Experience with regulatory submissions, including INDs, international clinical trial applications, and marketing applications in Common Technical Document format, is essential.
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 call Katherine Dunleavy on +1 646 367 2646 or upload your CV on 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.