Syneos Health
Syneos Health, a leading fully integrated biopharmaceutical solutions organization, is inviting applications for the position of Senior Regulatory Associate (CMC). With a global presence and a mission to accelerate the delivery of therapies worldwide, the company is seeking an experienced regulatory professional who thrives in a fast-paced, collaborative environment.
About Syneos Health
Syneos Health® operates across 110 countries with a team of over 29,000 professionals, dedicated to bringing life-changing therapies to market. The company leverages integrated clinical, medical, and commercial expertise to address evolving market challenges. With a focus on innovation and patient-centricity, Syneos Health has built a reputation for excellence in the biopharmaceutical industry.
Job Overview
Position: Sr. Regulatory Associate (CMC)
Location: Pune, India
Job ID: 25003846-7
Experience Required: Minimum 4 years
Education: Master’s in Pharmaceutical Sciences or Life Sciences (preferred)
The selected candidate will play a key role in the preparation, compilation, review, and submission of high-quality Chemistry, Manufacturing, and Controls (CMC) dossiers for global markets.
Key Responsibilities
Primary Responsibilities:
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Develop and submit regulatory CMC documentation including variations, renewals, and annual reports.
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Demonstrate practical knowledge of ICH guidelines, GMP requirements, and regulatory frameworks including FDA and EMA.
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Manage post-approval variation submissions for the EU market and contribute to pre-approval dossiers for Rest of World (ROW) markets.
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Provide regulatory support for change controls, impact assessments, and compliance reports.
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Collaborate with Quality, Manufacturing, and Analytical departments to ensure submission accuracy.
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Train and mentor junior team members on regulatory processes and standards.
Secondary Responsibilities:
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Track and update regulatory/CMC commitments using platforms such as RIMS and Veeva Vault.
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Maintain communication with cross-cultural teams and participate in client meetings.
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Ensure documentation and submissions align with client SOPs and project timelines.
Ideal Candidate Profile
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At least 4 years of hands-on experience in regulatory CMC documentation.
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Sound understanding of regulatory requirements for EU and ROW markets.
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Proficiency in tools like RIMS, Veeva Vault, and experience in managing document lifecycles.
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Strong organizational and communication skills.
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Ability to work independently and manage multiple projects in a consulting environment.
Why Work at Syneos Health?
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Career Development: Continuous learning and upskilling opportunities.
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Supportive Culture: Encouragement to bring your full, authentic self to work.
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Global Teamwork: A diverse and inclusive workplace spanning 110 countries.
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Recognition and Rewards: Peer recognition programs and competitive benefits.
At Syneos Health, your contributions will help bring life-saving therapies to market faster and more efficiently.
Apply Today
If you’re ready to make a global impact and grow your career in regulatory affairs, this opportunity at Syneos Health could be the next step in your professional journey.
To apply for this job please visit www.syneoshealth.com.
