Location: Mumbai, Maharashtra, India (Hybrid)
Company: Syneos Health
Job Type: Full-Time
Experience Required: 1–3 Years
Freshers Eligible: No
Job Requisition ID: 25107611
About the Company
Syneos Health is a globally recognized biopharmaceutical solutions organization focused on accelerating customer success across the drug development and commercialization lifecycle. The company partners with pharmaceutical, biotechnology, and healthcare innovators to support regulatory compliance, clinical development, and global market expansion.
With operations spanning multiple countries and therapeutic areas, Syneos Health provides professionals with exposure to international regulatory standards, pharmaceutical product registration processes, and global healthcare innovation.
Job Overview
Syneos Health is hiring a Regulatory Affairs Associate for its India Market operations in Mumbai. This opportunity is ideal for regulatory affairs professionals with hands-on experience in Indian pharmaceutical regulatory submissions, dossier management, and SUGAM portal operations.
The selected candidate will support regulatory activities related to drug registrations, import licenses, variations, labeling updates, and compliance documentation for pharmaceutical products in the Indian market.
Key Responsibilities
Participate in preparation and management of new drug registrations, renewals, site registrations, and variations
Handle regulatory submissions and import license activities for bulk drugs and pharmaceutical products
Work extensively on the SUGAM Portal for regulatory filing and submission management
Support preparation of regulatory documentation required for government tenders and submissions
Maintain and update internal databases, regulatory tracking systems, artworks, and dossiers
Coordinate with internal departments and external stakeholders for registration and maintenance activities
Assist in planning and execution of regulatory strategies for bulk drug registrations
Conduct bibliographic and scientific literature searches whenever required
Support labeling updates, product lifecycle management activities, and regulatory database maintenance
Prepare administrative regulatory documents including legalization requests, translations, filing, and archives
Organize meetings and support departmental coordination activities
Provide backup support for administrative functions within the regulatory affairs department when required
Required Skills & Qualifications
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Regulatory Affairs, or related field
1–3 years of experience in Regulatory Affairs within the pharmaceutical or healthcare industry
Mandatory experience in handling the Indian Pharmaceutical Market
Practical working knowledge of the SUGAM Portal
Understanding of CDSCO regulatory requirements and drug registration processes
Strong documentation, communication, and coordination skills
Ability to manage multiple regulatory projects and timelines simultaneously
Proficiency in dossier preparation, lifecycle management, and compliance documentation
Preferred Candidate Profile
Experience in pharmaceutical product registration and maintenance activities
Familiarity with regulatory artwork review and labeling compliance
Knowledge of import licensing and bulk drug registration procedures
Strong attention to detail and regulatory accuracy
Why Join Syneos Health?
Opportunity to work with one of the world’s leading life sciences organizations
Exposure to global pharmaceutical regulatory operations
Collaborative and innovation-driven work environment
Career growth opportunities in Regulatory Affairs and Clinical Development
Experience working on international healthcare and pharmaceutical projects
Important Note for Applicants
This role is designed for experienced Regulatory Affairs professionals with prior exposure to Indian pharmaceutical regulations and the SUGAM portal. Candidates without relevant regulatory affairs experience may explore entry-level pharmaceutical, pharmacovigilance, clinical research, or regulatory trainee opportunities before applying for this position.
How to Apply
Candidates interested in Regulatory Affairs jobs in Mumbai, CDSCO regulatory submission roles, pharmaceutical compliance careers, and SUGAM portal opportunities can apply through the official company careers portal.
For more verified global pharmaceutical, clinical research, pharmacovigilance, and regulatory affairs jobs, visit ThePharmaDaily.com.
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Sheffield |Oxfordshire :
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Canada |Quebec :
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Japan | Saitama |Tokyo :
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