Location: India (Remote / Gurugram Hybrid)
Company: Syneos Health
Job Type: Full-Time
Job Requisition ID: 25105261
Experience Required: 6 Months to 2 Years
Freshers Eligible: Internship experience preferred
About the Company
Syneos Health is a globally recognized biopharmaceutical solutions organization that supports pharmaceutical, biotechnology, and medical device companies across the entire drug development lifecycle. The company partners with innovators worldwide to accelerate clinical development, regulatory approvals, and commercialization strategies.
With a strong global presence and expertise in regulatory affairs, clinical research, pharmacovigilance, and medical writing, Syneos Health offers professionals an opportunity to work on high-impact healthcare projects across international markets.
Job Overview
Syneos Health is hiring for the position of Regulatory Associate – EU Market, CMC Module 3 for candidates with experience in regulatory affairs, CMC documentation, and lifecycle management activities. This role focuses on supporting regulatory submissions for global markets including Europe (EU), GCC, and APAC regions.
Candidates with exposure to CMC regulatory activities for small molecules and hands-on experience or internship exposure in regulatory documentation are highly preferred.
This opportunity is ideal for pharmacy, life sciences, biotechnology, and regulatory affairs professionals looking to build a long-term career in global regulatory operations and pharmaceutical compliance.
Key Responsibilities
Assist in the preparation of product development and regulatory documentation
Support the compilation and submission of regulatory dossiers including INDs, NDAs, MAAs, DMFs, variations, renewals, and lifecycle management documents
Participate in CMC Module 3 documentation activities for small molecule products
Conduct regulatory intelligence and research for global pharmaceutical markets
Perform document quality checks and ensure compliance with international regulatory guidelines
Support orphan drug designation requests and regulatory strategy documentation
Coordinate with internal teams and stakeholders for submission-related activities
Gather, analyze, and report regulatory information and project data
Prepare detailed reports, correspondence, and regulatory tracking documents
Maintain compliance with EU and international regulatory standards
Required Skills and Qualifications
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or related healthcare discipline
Minimum 6 months to 2 years of experience in Regulatory Affairs
Internship experience in regulatory affairs or CMC documentation will be considered valuable
Experience in CMC documentation for small molecule products preferred
Exposure to EU, GCC, or APAC pharmaceutical markets is an added advantage
Strong knowledge of regulatory submission processes and lifecycle management
Excellent communication and interpersonal skills
Advanced proficiency in Microsoft Office applications
Strong analytical skills and attention to detail
Ability to manage multiple projects and work independently or within cross-functional teams
Fluency in written and spoken English
Preferred Candidate Profile
Candidates with hands-on experience in EU regulatory submissions
Professionals familiar with pharmaceutical compliance and regulatory operations
Applicants seeking remote regulatory affairs jobs in India
Regulatory professionals interested in global pharmaceutical market exposure
Why Join Syneos Health?
Work with one of the world’s leading clinical and regulatory organizations
Gain exposure to international pharmaceutical regulatory frameworks
Collaborate with global healthcare and life sciences experts
Access career development programs and structured learning opportunities
Opportunity to contribute to innovative drug development projects worldwide
Over the last five years, Syneos Health has contributed to regulatory and clinical programs associated with the majority of newly approved FDA and EMA products globally.
Important Note for Applicants
This role is suitable for candidates with prior internship exposure or early professional experience in regulatory affairs. Complete freshers without any internship or CMC exposure may require foundational training in regulatory documentation and pharmaceutical submissions before applying.
How to Apply
Interested candidates can apply through the official careers portal of Syneos Health.
For more verified global pharmaceutical, pharmacovigilance, clinical research, regulatory affairs, medical writing, and biotech job opportunities, visit ThePharmaDaily.com.
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Sheffield |Oxfordshire :
Witney |Ontario :
Renfrew | North York | Australia | Uxbridge | Richmond Hill | Mississauga |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
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Auckland |New Zealand :
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Austria |Vienna :
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Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
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Japan | Saitama |Tokyo :
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