Senior Executive / Manager II – India Regulatory Affairs & Business Continuity
Company: Sun Pharmaceutical Industries Ltd
Business Unit: R&D – Regulatory Affairs (India)
Location: Baroda (Vadodara), Gujarat, India
Work Location: Tandalja – R&D
Job Type: Full-Time
Job Grade: G11A
Experience Required: 8–10 Years
Education Required: Master of Pharmacy (M.Pharm)
Job Overview
Sun Pharmaceutical Industries Ltd is seeking an experienced Senior Executive / Manager II – India Regulatory Affairs & Business Continuity to support regulatory strategy, submissions, and lifecycle management for products intended for the Indian market. This role plays a critical part in ensuring compliance with Indian regulatory frameworks while enabling timely product approvals and market access.
The position requires strong expertise in CMC review, clinical and bioequivalence documentation, SUGAM portal submissions, and coordination with cross-functional teams across R&D and manufacturing.
Key Responsibilities
Regulatory Strategy and Submissions
Develop and evaluate regulatory strategies for products to be registered in India, including new drugs, subsequent new drugs (SNDs), and fixed-dose combinations (FDCs).
Coordinate with cross-functional teams to obtain complete and compliant documentation for regulatory filings.
Compile and submit regulatory dossiers in alignment with Indian regulatory guidelines and expectations.
CMC, Clinical, and Labeling Review
Review Chemistry, Manufacturing, and Controls (CMC) documents for bulk drugs and finished formulations.
Evaluate specifications for APIs and formulations as per CDSCO regulatory requirements.
Review clinical trial and bioequivalence (BE) study documentation for regulatory submissions.
Review draft labels, cartons, and specimen packaging for regulatory compliance.
Prepare prescribing information by referencing approved international product labels.
Scientific and Literature Evaluation
Conduct literature searches using recognized scientific and regulatory databases to support application strategies.
Prepare safety and efficacy rationales for new drugs and FDCs based on published scientific literature.
Draft executive summaries for Subject Expert Committee (SEC) referrals for products not yet approved in India.
Regulatory Filing and Coordination
Compile final CMC, clinical trial, and BE documents received from cross-functional teams.
Submit ND, SND, and FDC applications through the SUGAM portal for domestic manufacturing, marketing authorization, and clinical trial approvals.
Ensure timely follow-ups and effective coordination to support regulatory milestones.
Required Qualifications and Experience
Education
Master of Pharmacy (M.Pharm)
Experience
8–10 years of hands-on experience in India Regulatory Affairs within pharmaceutical R&D or manufacturing organizations
Proven experience with CDSCO submissions, SUGAM portal filings, CMC review, and regulatory documentation
Key Skills and Competencies
Strong knowledge of Indian pharmaceutical regulatory guidelines and CDSCO requirements
Expertise in CMC documentation, clinical trial, and bioequivalence submissions
Experience with SUGAM portal regulatory filings
Ability to interpret scientific literature and regulatory policies
Strong cross-functional coordination and stakeholder management skills
High attention to detail, documentation accuracy, and compliance standards
Excellent written and verbal communication skills
Why Join Sun Pharma
At Sun Pharma, you are encouraged to grow continuously, take ownership of your career, and collaborate within a supportive and high-performance environment. The organization offers strong professional development opportunities, robust benefits, and the chance to contribute meaningfully to global healthcare outcomes.
Gujarat :
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