Consultant Regulatory CMC - Permanent - Boston, MA
Proclinical is seeking a Senior Regulatory Affairs Associate or a Regulatory Affairs Consultant with a strong background in CMC post-approval. This permanent position is located in Boston, MA.
Primary Responsibilities:
The successful candidate will provide lifecycle management support to a broad, global portfolio of commercial products.
Skills & Requirements:
- Minimum of 3 years of significant post-approval CMC experience in global markets, including experience with the FDA and EU Agencies.
- Excellent communication skills and the ability to multi-task, stay organized, and prioritize.
- Incredible attention to detail and previous experience leading meetings and planning submission timelines.
- Fluency in French is a plus, but not required.
- CMC Vaccines authoring experience is preferred, but consideration will be given to those with strong CMC Biologics authoring experience.
The Consultant Regulatory CMC will:
- Conduct CMC Variations/Submissions and CMC Change control assessments.
- Carry out global assessment of change controls in current markets and support for new Markets Assessment of existing change controls in support of market extension.
- Lead initial planning and determination of content and timing for submission planning.
- Interact with other groups for confirmation of timelines considering all relevant parameters for accurate planning.
- Maintain a record of activities to ensure all product activities are kept on target.
- Coordinate submission writing, review, and approval process with contributors and stakeholders.
- Dispatch CMC dossiers and secure document approvals.
- Respond to Health Authority Questions and support technical aspects of queries in coordination with the impacted SMEs.
- Update HA question record in Vault and coordinate dispatch of information to Affiliate noting status changes in Veeva.
If you are having difficulty in applying or if you have any questions, please contact Funmi Gbadamosi at +(1) 617-963-0342 or f.gbadamosi@proclinical.com.
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.
.png)
