CMC Regulatory Affairs Consultant

MBS Consulting is a dynamic and growing biopharmaceutical consulting firm supporting biotech and pharmaceutical companies in developing innovative therapies across the various stages of development and commercialisation. We foster a collaborative and supportive environment where employees are empowered to make a real difference for clients’ projects.

Role Description

We are seeking a highly motivated and experienced CMC Regulatory Affairs Consultant to join our growing team. This critical role will be responsible for providing expert CMC regulatory guidance and support for our drug development programs. The ideal candidate will have a strong understanding of global CMC regulatory requirements and experience in preparing and submitting CMC documentation to health authorities.

Responsibilities

1. Provide expert CMC regulatory advice to internal teams on all aspects of drug development, from early phase development through commercialization.
2. Prepare and review CMC sections of regulatory submissions, including INDs, NDAs, MAAs, and variations.
3. Ensure CMC regulatory compliance with applicable global regulations and guidelines (e.g., FDA, EMA, ICH).
4. Collaborate with cross-functional teams (e.g., Development, Manufacturing, Quality) to address CMC regulatory questions and issues.
5. Interact with health authorities on CMC-related matters.
6. Monitor and interpret evolving regulatory landscape and provide updates to internal stakeholders.
7. Develop and maintain CMC regulatory strategies for drug development programs.
8. Participate in regulatory agency meetings and teleconferences.
9. Manage CMC regulatory projects and timelines effectively.
10. Contribute to the development and improvement of CMC regulatory processes and procedures.

Qualifications

1. Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy, Chemical Engineering) required; advanced degree (e.g., MS, PhD) preferred.
2. Minimum 5 years of experience in CMC regulatory affairs within the pharmaceutical or biotechnology industry.
3. RAC (US) certification is a plus.
4. In-depth knowledge of global CMC regulatory requirements and guidelines (e.g., FDA, EMA, ICH).
5. Proven experience in preparing and submitting CMC documentation to health authorities.
6. Strong understanding of drug development processes and CMC-related activities.
7. Excellent written and verbal communication skills.
8. Ability to work independently and as part of a team.
9. Strong problem-solving and analytical skills.
10. Detail-oriented and organized.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Legal

Industries

Business Consulting and Services

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