Syneos Health is hiring a Regulatory Affairs Associate for its India Market team in Mumbai on a hybrid basis. This full-time pharma job is perfect for candidates with 1-3 years of experience and hands-on knowledge of the SUGAM Portal. Excellent opportunity for professionals seeking Regulatory Affairs jobs, pharma jobs in Mumbai, and careers in the CRO and life sciences sector.
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About the Company
Syneos Health is a leading fully integrated biopharmaceutical solutions organization that accelerates customer success across drug development and commercialization. With a strong global footprint, the company partners with innovators to navigate regulatory complexities and bring therapies to market faster.
Syneos Health has supported 94% of all novel FDA-approved drugs and 95% of EMA-authorized products in recent years. Known for its agile culture, inclusive environment, and focus on employee development, Syneos offers excellent career growth, learning opportunities, and a collaborative work culture in the pharmaceutical services industry.
Job Details
- Company Name: Syneos Health
- Experience: 1-3 years (with India Market experience preferred)
- Qualification: Bachelor’s / Master’s degree in Life Sciences, Pharmacy, or related field
- Location: Mumbai (Hybrid)
- Work Type: Full time, Hybrid
Job Description
Syneos Health is recruiting a Regulatory Affairs Associate to support regulatory activities for the India Market. The role involves active participation in new drug registrations, renewals, variations, and import licenses, with a strong focus on hands-on work with the SUGAM Portal.
This position provides an excellent opportunity to work with internal and external stakeholders while contributing to efficient regulatory submissions and compliance for bulk drugs and pharmaceutical products.
Regulatory Affairs Associate
- Department: Regulatory Affairs – India Market
- Market: Pharmaceutical / CRO Services
- Role: Regulatory Affairs Associate
- Experience: 1–3 years
- Education/Qualification: Degree in Pharmacy, Life Sciences, or related discipline
Skills/Qualifications
- 1-3 years of experience in Regulatory Affairs
- Hands-on experience with SUGAM Portal
- Strong understanding of Indian regulatory requirements for drug registrations
- Experience in new drug registrations, renewals, site registrations, and variations
- Excellent documentation and database management skills
- Good knowledge of bibliographic searches and dossier preparation
- Strong organizational and multitasking abilities
- Effective communication and stakeholder management skills
- Proficiency in MS Office and internal regulatory tools
- Ability to work independently and in a team
Key Responsibilities
- Prepare and manage new drug registrations, renewals, and variations
- Handle site registrations and import licenses for bulk drugs
- Actively use SUGAM Portal for regulatory submissions
- Support preparation of documents for tenders
- Update and manage internal databases for artworks and dossiers
- Participate in planning and strategy for bulk drug registrations
- Prepare administrative documents including mail, translations, and filings
- Support labelling updates and new product registrations
- Liaise with internal teams and external stakeholders
- Organize meetings and provide back-up administrative support
Benefits/Perks
- Competitive salary and performance-based incentives
- Hybrid work model with flexibility
- Career development and progression opportunities
- Technical and therapeutic area training
- Inclusive and supportive work culture
- Peer recognition and total rewards program
- Exposure to global regulatory projects and innovative therapies
How to Apply
Interested candidates can apply directly for Job ID 25107611 through the official Syneos Health careers portal.
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Apply now and advance your career in Regulatory Affairs with a leading life sciences services organization!
Why You Should Join
Syneos Health offers a dynamic and inclusive workplace where professionals can grow while contributing to meaningful healthcare solutions. As a Regulatory Affairs Associate, you will gain valuable India Market experience and work on diverse regulatory projects that impact drug availability and patient care.
The company is committed to employee development, innovation, and work-life balance, making it an ideal place for long-term career stability and professional growth in the pharmaceutical industry.
FAQs
What is the experience required for the Regulatory Affairs Associate role at Syneos Health?
Candidates need 1-3 years of experience in Regulatory Affairs with hands-on knowledge of the SUGAM Portal and India Market exposure.
Is the Syneos Health job in Mumbai fully remote or hybrid?
The position is Hybrid, based in Mumbai.
What key skill is mandatory for this pharma job?
Hands-on experience with the SUGAM Portal is essential for managing regulatory submissions.
What career growth does this Regulatory Affairs role offer?
It provides exposure to new drug registrations, variations, and stakeholder coordination, opening doors to senior regulatory positions within a global CRO.
