Regulatory Associate CMC job at Syneos Health, Apply Now!
Syneos Health is hiring a Regulatory Associate (CMC) in Pune. If you have at least 1 year of experience in preparing global CMC dossiers and lifecycle maintenance submissions, this is a great opportunity to work with a global biopharma leader. Bring your expertise in regulatory affairs and make an impact in markets like EU and ROW. Join a collaborative, purpose-driven team focused on innovation and patient outcomes.
- Location: Pune
- Job ID: 25003845-5
About Company:
Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs, and commercial insights into outcomes to meet the demands of today’s healthcare markets.
Our Clinical Development model keeps the customer and patient at the center of everything we do. We continually seek ways to simplify and streamline our processes to make Syneos Health both easier to work with and to work for.
Summary
Under supervision, the Regulatory Associate supports agency submissions, research, and product development. Responsibilities include preparing, tracking, and submitting global regulatory documentation for new submissions, variations, renewals, MATs, and lifecycle activities. Exposure to regulatory tools like Veeva RIM is a plus.
Job Responsibilities
Primary Duties:
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Understand current global regulatory guidelines (ICH, FDA, EMA) for post-approval changes.
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Prepare high-quality global CMC dossiers for variations, renewals, annual reports, and lifecycle maintenance (e.g., change control assessment, response to queries).
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Interpret client SOPs for daily execution tasks as Regulatory Associate.
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Support preparation and finalization of quality compliance reports (e.g., APQR).
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Build ancillary and document request trackers.
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Liaise with functions to gather documents for global submissions.
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Ensure compliance and meet submission timelines through timely escalation.
Secondary Duties:
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Understand regional regulatory requirements (LATAM, APAC, ME, AF, China) for ROW marketing authorizations.
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Support tracking and submission of regulatory/CMC commitments and database updates.
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Familiarity with RIMS/VEEVA Vault preferred for Regulatory Associate.
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Work effectively in cross-cultural and virtual teams.
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Strong communication skills to update regulatory activities in meetings.
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Willingness to learn and adapt.
Qualifications
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Minimum 1 year of experience in preparing global CMC dossiers and lifecycle maintenance submissions.
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Master’s degree in pharmaceutical sciences (preferred) or other life sciences.
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Post-approval variation experience for the EU market is mandatory as Regulatory Associate.
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Pre-approval MAA dossier experience for ROW is preferred.
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Experience contributing to submissions like IND, PMA, NDA, MAA, and CTD, including electronic formats.
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Strong interpersonal, written, and verbal communication skills.
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Exceptional customer service, quality management, and Microsoft Office skills.
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Ability to multitask across varied project instructions.
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Fluent in English.
Keywords: Regulatory Associate CMC job, Syneos Health careers, CMC regulatory jobs Pune, pharmaceutical regulatory affairs jobs, global CMC dossier preparation, post-approval variation jobs, regulatory submissions careers
