Regulatory CMC Manager/Regulatory Consulting - hybrid/remote (Serbia, UK, Portugal)

Syneos Health, Inc.; Greater London; Hybrid; GBP 65,000 - 85,000; Full time

Job summary

A biopharmaceutical solutions organization is seeking an experienced Regulatory CMC Manager to support global regulatory CMC execution for multi-product. Candidates will be responsible for authoring CMC sections for Marketing Authorisation dossiers, reviewing CMC submissions, and collaborating with cross-functional teams. Strong regulatory writing skills and experience with global regulatory strategies are essential for success in this role, which offers a hybrid work model in London.

Benefits

Career development and progression

Total Self culture

Technical and therapeutic area training

Qualifications

• Proficient in authoring CMC sections for regulatory submissions.
• Experience with global regulatory strategies.
• Ability to manage interactions with regulatory agencies.

Responsibilities

• Support execution of global regulatory CMC for multi-product.
• Author CMC sections for Marketing Authorisation dossiers.
• Work effectively on cross-functional teams.

Skills

Regulatory writing

Cross-functional collaboration

CMC documentation

Job description

Regulatory CMC Manager / Regulatory Consulting (Hybrid/Remote)

Updated: Dec 15, 2025
Location: London, United Kingdom
Job ID: 25104247-OTHLOC-3526-2DR

Description

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate about changing lives.

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels they belong.

Job Responsibilities

General Position Summary: The Chemistry Manufacturing Controls Manager will support the execution of multi-product global regulatory CMC for products at Marketing Authorisation Application Stage. This role contributes to the preparation and submission of regulatory CMC documentation and provides regulatory support to various cross‑functional teams and may contribute to strategic Regulatory CMC discussions.

• Authoring of CMC sections for Marketing Authorisations dossiers.
• Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies.
• Works with regulatory colleagues in development of global regulatory CMC strategies and submissions.
• Participates effectively on cross‑functional teams and may serve as the primary regulatory CMC contact for assigned products and projects.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

Experienced CMC Regulatory Manager