Associate Director / Director CMC
Proclinical is currently recruiting for an Associate Regulatory Affairs CMC Director for a biotechnology company located in Baltimore, Maryland. Successful candidate will provide regulatory guidance to ensure development activities, manufacturing, and testing for all products are compliant with the relevant regulations, guidelines and industry standards.
- Develop CMC-related submission content outlines and establish submission timelines in collaboration with relevant project team members; manage execution of submission preparation, review, approval and delivery to the appropriate Regulatory Authority.
- Represent Regulatory Affairs CMC in project meetings as assigned.
- Interact with Process Development, Manufacturing, Quality Assurance and Quality Control personnel contributing to a submission regarding content and timelines; ensure sections provided to Regulatory are consistent with regulatory requirements and internal submission format standards; edit content of submissions based on regulatory requirements.
- Review and provide comments on SOPs, stability protocols, product container labeling, product specifications, comparability protocols and reports, quality agreements, pharmacy manuals, investigator brochures and other related CMC documents.
- Continue professional development by attending regulatory CMC-related meetings applicable to biopharmaceutical products.
- Aid in the implementation of infrastructure necessary for successful completion of regulatory projects (e.g., preparation of Regulatory-related written processes and procedures, review of departmental SOPs, establishment of electronic document standards).
- Provide support to Senior Director, Regulatory Affairs CMC as requested.
Skills and Requirements:
- Bachelor's degree in a scientific discipline.
- 8+ years in a Regulatory department at biopharmaceutical/pharmaceutical company.
- 5+ years working with biologics/large molecules with a proven track record in preparing and submitting high quality submissions that meet regional Regulatory Authorities' requirements.
- Direct experience assembling Regulatory applications in eCTD format.
- Knowledge of FDA, ICH and EMA requirements for biopharmaceutical products required.
- Excellent verbal and written communication skills.
- Strong project management and organizational skills with ability to multi-task on several projects.
- Highly flexible, adaptable and experienced in a fast-paced environment.
- Expertise in MS Office; experience with Electronic Document Management Systems for preparing, formatting, and finalizing regulatory submissions.
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 Nicholas Walker at (+1) 646-367-2908 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.
Proclinical Staffing is an equal opportunity employer.