Principal / Senior Regulatory Affairs CMC Consultant
Can be remotely based across the UK
This role is with a rapidly growing international regulatory consulting organization focused on advancing healthcare innovation through expert scientific and regulatory support. The company partners with clients to streamline product development, reduce time-to-market, and deliver strategic solutions across global markets. As a Principal or Senior Regulatory Affairs CMC Consultant, you will play a key leadership role, providing high-level regulatory and technical guidance for complex therapeutics. The position offers opportunities to mentor team members, influence business growth, and engage directly with global regulatory authorities. This role can be remotely based across the United Kingdom with a once-a-month in office requirement.
Responsibilities
* Provide strategic, technical, and regulatory CMC advice to clients, supporting the development of human medicinal products.
* Develop innovative drug development plans, data gap analyses, and global regulatory strategies for complex products.
* Author, review, and contribute to key regulatory documents, including development plans, clinical trial applications, and marketing authorizations.
* Lead multi-jurisdictional projects, ensuring delivery within timelines and budget while maintaining high-quality standards.
* Represent clients in interactions with regulatory agencies and provide solutions to regulatory challenges and objections.
* Lead, mentor, and manage team members while supporting business development initiatives and client relationship growth.
Requirements
* Bachelor’s degree in a science-related field, with an advanced degree (MSc or preferably PhD) in a biomedical or related discipline.
* Principal level - minimum of 10 years’ experience in CMC development, regulatory strategy, and compliance within the pharmaceutical or biotech industry. Senior level - minimum of 5 years experience.
* Strong knowledge of global regulatory requirements, including FDA, EMA, and ICH guidelines.
* Proven experience managing regulatory submissions across MAA/BLA and interactions with agencies such as FDA, MHRA, EMA, or TGA.
* Experience working on biologics programs is preferred
* Demonstrated ability to lead teams, mentor staff, and deliver strategic consultancy services to clients.
* Excellent communication, organizational, and problem-solving skills, with flexibility to travel and work across international teams.
Contact
If you are interested in learning more, apply to this job post and reach out to Amit at .