Location: Mumbai, India (Hybrid)
Company: Syneos Health
Job ID: 25107611
Experience Required: 1–3 years (Freshers may apply if they have strong regulatory knowledge or internship experience)
About the Company
Syneos Health is a leading global biopharmaceutical solutions organization that accelerates drug development and commercialization. With a strong presence across clinical research, regulatory, and commercialization domains, the organization partners with global innovators to bring life-changing therapies to market efficiently.
Job Overview
The Regulatory Affairs Associate – India Market role is designed for professionals with foundational regulatory experience who are looking to build expertise in Indian regulatory submissions and lifecycle management. The role focuses on handling regulatory documentation, submissions, and compliance activities aligned with CDSCO requirements.
Key Responsibilities
Prepare and manage regulatory dossiers for new drug registrations, renewals, variations, and import licenses for bulk drugs
Work extensively on the SUGAM Portal for regulatory submissions in India
Support preparation and submission of documents for government tenders
Maintain and update internal regulatory databases, artwork systems, and dossier tracking tools
Assist in regulatory strategy planning for bulk drug registrations in coordination with internal and external stakeholders
Conduct bibliographic searches and gather scientific/regulatory information as required
Support labeling activities, lifecycle management, and variation submissions
Coordinate with cross-functional teams, affiliates, and external partners to ensure timely and compliant submissions
Prepare administrative documentation including correspondence, legalization, translation coordination, and archival activities
Organize regulatory meetings and provide operational support to the regulatory team
Required Qualifications
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field
1–3 years of experience in Regulatory Affairs (India Market preferred)
Hands-on experience with CDSCO submissions and SUGAM Portal is highly desirable
Strong understanding of Indian regulatory guidelines and documentation requirements
Good organizational, documentation, and communication skills
Ability to manage multiple regulatory activities within timelines
Why This Role Matters
Direct exposure to India regulatory framework and CDSCO processes
Opportunity to work on end-to-end regulatory lifecycle activities
Hands-on experience with real-time submissions and compliance management
Strong foundation for career growth in Regulatory Affairs, Drug Development, and Global Submissions
Important Note for Applicants
Candidates with relevant internships, regulatory training, or exposure to CDSCO processes may be considered for this role even with limited experience. However, familiarity with regulatory documentation and submission workflows is expected.
How to Apply
Apply through the official careers page of Syneos Health or explore verified global opportunities on ThePharmaDaily.com.
Disclaimer
The responsibilities listed above are indicative and may evolve based on business requirements. Equivalent qualifications and transferable skills will be considered in line with company policies and regional employment regulations.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
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Remote, USA | Castlebar | Melbourne | Remote | Victoria | Nairobi | Green Way | Faridabad | Minnesota | Leinster | Belgium | Bishop | Slovakia | Thailand | Regulatory Labeling Manager (NA and LATAM Only) | Tulsa | Lenexa | Ireland | McFarland | Hungary | Remote - Middle East | Remote - South America (Latin Americal) | Hammond | Lousiana | Manipal | Zaragoza | Medan | Xzagreb | Bountiful | French | Springville | Riga | Remote - Europe | Texas | Switzerland | Blue Bell | Remote - Africa |Republic of Colombia :
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