Job Summary:
We are seeking an experienced Regulatory CMC Consultant to provide expert guidance on regulatory compliance for pharmaceutical and biotechnology products. The ideal candidate will have a deep understanding of global regulatory requirements related to CMC, including FDA, EMA, ICH, and other health authority guidelines. This role involves collaborating with cross-functional teams to ensure that manufacturing, quality, and regulatory requirements are met for successful product development and approvals.
Key Responsibilities:
- Develop and review CMC regulatory strategies for drug development, submissions, and lifecycle management.
- Prepare, compile, and submit CMC sections of regulatory submissions, including INDs, NDAs, BLAs, MAAs, and variations.
- Ensure compliance with global regulatory requirements for manufacturing, quality, and supply chain operations.
- Provide expert guidance on CMC-related regulatory requirements, including stability studies, analytical methods, specifications, and control strategies.
- Collaborate with R&D, manufacturing, quality, and regulatory teams to support product development and approval processes.
- Monitor and assess changes in CMC regulatory guidelines and ensure timely implementation of updates.
- Review and assess technical documentation, including drug substance and drug product information, to ensure regulatory compliance.
- Support responses to health authority queries and regulatory inspections related to CMC aspects.
- Provide strategic input on CMC regulatory considerations for new product development, scale-up, and post-approval changes.
Required Qualifications:
- Bachelor’s, Master’s, or PhD in Chemistry, Pharmacy, Biochemistry, or a related field.
- Minimum of 5 years of experience in Regulatory CMC within the pharmaceutical or biotechnology industry.
- Strong knowledge of global CMC regulations, including FDA, EMA, ICH, and other regulatory authorities.
- Experience with regulatory submissions, including IND, NDA, BLA, MAA, and post-approval changes.
- Excellent communication and technical writing skills.
- Ability to work independently and collaboratively in a fast-paced environment.
- Proficiency in regulatory software and document management systems.
Preferred Qualifications:
- Regulatory Affairs Certification (RAC) or equivalent.
- Experience with biologics, biosimilars, or advanced therapies.
- Familiarity with electronic submission tools and regulatory databases.
Location: Remote
Employment Type: Contract/Consulting
Join our team and contribute to the success of regulatory CMC strategies that ensure product quality, compliance, and market approval. Apply today!
