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Regulatory Affairs Associate (Mumbai/ Hybrid) India Mkt

Syneos Health
Syneos Health
Fresher years
3-5 LPA
Remote, India, India
9 April 30, 2026
Job Description
Job Type: Remote Education: B.Pharm, M.Pharm, Pharm D., BSc., MSc., Lifesciences graduate Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Regulatory Affairs Associate – India Market

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.