Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
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 deliver – for one another, our customers, and, most importantly, for those in need.
Discover what your 25,000 future colleagues already know:
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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
Job Responsibilities
General Position Summary
The Chemistry Manufacturing Controls Manager will support the execution of global regulatory CMC strategies for marketed and development products. This role contributes to the preparation and submission of regulatory CMC documentation for a small molecule. This role also provides regulatory support and guidance to various cross functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into development and commercial programs.
Key Duties & Responsibilities
Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
Contributes to the development of global regulatory CMC strategies for commercial products
Works with regulatory colleagues in development of global regulatory CMC strategies and Submissions
Provides regulatory CMC guidance to cross-functional teams and key stakeholders
Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
Required Education Level & Experience
Strong interpersonal skills to exchange complex information with others and to guide others
Proficiency in regulatory (FDA, EMA, Health Canada, LATAM, Middle East, and ICH) guidelines
Experience in the preparation, including writing, of CMC submissions
Strategic thinking and strong problem solving skills
Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner
Strong sense of planning and prioritization, and the ability to work with all levels of management
Capable of strategic thinking with ability to resolve complex and ambiguous situations
Sound knowledge of cGMP, FDA, EMA, ICH
Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
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.
Skills Required
- Experience with Veeva RIM
- Experience in small-molecule CMC regulatory submissions and writing CMC documentation
- Proficiency with global regulatory guidelines (FDA, EMA, Health Canada, LATAM, Middle East, ICH)
- Sound knowledge of cGMP
- Experience providing regulatory CMC guidance to cross-functional teams
- Knowledge of product compliance topics including change controls, deviations, and GMP investigations
- Strong interpersonal, communication, planning, prioritization, and stakeholder management skills
- Strategic thinking and strong problem-solving skills; ability to resolve complex and ambiguous situations
- Bachelor's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs/Biologics/Medical Devices, or related life-science field
Syneos Health Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Syneos Health and has not been reviewed or approved by Syneos Health.
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Leave & Time Off Breadth — Unlimited PTO for managers and flexible time‑off options make time away accessible and support work‑life balance. Day‑to‑day usability can depend on team and workload, but the policy breadth is a clear strength.
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Retirement Support — A 401(k) with company match is frequently highlighted as a strong component of the package. Despite vesting details to confirm, the retirement offering adds meaningful long‑term value.
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Parental & Family Support — Partnership with Maven provides fertility, adoption support, parental‑leave guidance, and women’s health resources across multiple regions. This family‑building support enhances the overall total rewards appeal.
Syneos Health Insights
What We Do
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. We bring together a talented team of professionals, who work across more than 110 countries, with a deep understanding of patient and physician behaviors and market dynamics. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment.
