ProClinical is seeking a Manager, CMC Regulatory Affairs for an exciting growing biopharmaceutical company developing therapies for rare / orphan diseases. They 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. Manager, CMC Regulatory Affairs manages all regulatory CMC aspects of the company throughout their lifecycle with minimum supervision. This includes early development, development/scale up, and commercial products. He/she is responsible for the integration of the regulatory CMC strategy of all submissions and managing interactions with external regulatory consultant services on CMC issues.
- Prepare, author, review, coordinate, manage or maintain simple and complex regulatory submissions, including original INDs, IND amendments, IMPDs, annual reports and agency meeting briefing documents in accordance with applicable regulations
- Translate regulatory requirements into practical, workable submission plans
- Develop and maintain submission timelines for CMC related issues
- Coordinate the authoring, review and comment resolution for related submissions
- Provide thoughtful & accurate comments during document review with focus on US, international, and ICH regulatory guidelines
- Interface with external regulatory groups, such as contract manufacturers, development partners, consultants and technical writers
- Act as liaison between Regulatory Affairs and other functional areas
- Represent Regulatory Affairs in cross-functional team meetings
- Initiate and/or contribute to process improvements which have an impact on Regulatory Affairs, Quality Assurance or other departments
- Review and communicate current and emerging regulatory requirements
- Author and review standard operating procedures (SOPs)
- Develop and maintain current regulatory knowledge
Skills and Requirements:
- The successful candidate must possess a Bachelor's degree in pharmacy, or process manufacturing related healthcare functional area.
- Advanced Scientific or Process Engineering degree is desirable
- Background in biologics manufacturing process, process validation, and project management are required.
- The candidate must have 3 to 5 years of regulatory experience in the pharmaceutical or biotechnology industry as it pertains to CMC regulatory affairs or biologics manufacturing process
- Experience working in small molecule is desirable
- The candidate must have a solid understanding of FDA regulations, international regulations and the ICH guidelines, as well as a comprehension of the drug development process
- Experience with regulatory submissions in Common Technical Document format.
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 resume 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.