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

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

Updated: Yesterday
Location: PRT-Remote
Job ID:25104247

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 places the customer and the patient at the centre of everything we do. Whether you join us in a Functional Service Provider partnership or a Full‑Service environment, you’ll collaborate with problem‑solvers, innovating as a team to help our customers achieve their goals.

Job Responsibilities

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

Additional Information

Tasks, duties, and responsibilities are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, or job responsibilities. Equivalent experience, skills, and/or education may also be considered, and qualifications of incumbents may differ from those listed in the Job Description. The Company will determine what constitutes equivalency to the qualifications described above. The Company commits to compliance with the EU Equality Directive, the Americans with Disabilities Act, and all applicable legislation in each country of operation.

Summary

Experienced CMC Regulatory Manager. At Syneos Health, we are dedicated to building a diverse, inclusive, and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway.

Syneos Health® (Nasdaq: SYNH) supports a diverse, equitable, and inclusive culture and is a leading integrated biopharmaceutical solutions organization.

Phone: 919 876 9300
Fax: 919 876 9360
Toll-Free: 866 462 7373

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of the application process, including the use of this website, please contact us at Email: jobs@syneoshealth.com.