Job Title: Senior Executive / Manager II – India Regulatory Affairs
Company: Sun Pharmaceutical Industries Ltd.
Location: Vadodara (Baroda), Gujarat, India – R&D Center (Tandalja)
Department: R&D – Regulatory Affairs
Job Type: Full-Time
Experience Required: 8–10 Years of Experience in Regulatory Affairs, preferably in Indian Regulatory Submissions and Compliance
About Sun Pharmaceutical Industries Ltd.
Sun Pharmaceutical Industries Ltd. is one of the world’s leading specialty generic pharmaceutical companies, delivering high-quality and affordable medicines across global markets. With a strong presence in more than 100 countries, Sun Pharma focuses on innovation, research, and regulatory excellence to support global healthcare needs.
The company fosters a collaborative and growth-oriented work culture where professionals are encouraged to take initiative, develop expertise, and contribute to advancing pharmaceutical innovation and patient care.
Role Overview
The Senior Executive / Manager II – India Regulatory Affairs will be responsible for managing regulatory strategies and submissions for pharmaceutical products in India. The role involves coordination with cross-functional teams to compile regulatory dossiers, review technical documentation, and ensure compliance with Indian regulatory requirements.
The position plays a critical role in supporting regulatory approvals for new drugs, fixed-dose combinations (FDCs), and clinical trials by ensuring accurate documentation and regulatory alignment.
Key Responsibilities
Regulatory Strategy and Submission Planning
Evaluate and develop regulatory strategies for pharmaceutical products intended for registration in India.
Support regulatory planning for new drug applications, supplemental submissions, and fixed-dose combination approvals.
Cross-Functional Coordination
Collaborate with cross-functional teams including R&D, quality assurance, clinical research, and manufacturing to collect and review documentation required for regulatory submissions.
CMC Documentation Review
Review Chemistry, Manufacturing, and Controls (CMC) documentation to ensure compliance with regulatory guidelines for inclusion in submission dossiers.
Evaluate specifications for bulk drugs and finished formulations based on regulatory expectations.
Clinical and Bioequivalence Documentation Review
Review clinical trial and bioequivalence (BE) study documentation for inclusion in regulatory submissions.
Ensure all clinical and study data meet regulatory standards and submission requirements.
Scientific Literature and Regulatory Research
Conduct literature searches using scientific databases and regulatory resources to support submission strategies.
Prepare scientific justifications related to safety and efficacy of new drugs or fixed-dose combinations based on published evidence.
Regulatory Documentation and SEC Submissions
Prepare executive summaries for Subject Expert Committee (SEC) referrals for drugs not yet approved in India.
Compile complete regulatory dossiers including CMC, clinical trial, and bioequivalence documentation.
Regulatory Filing and Portal Management
Submit regulatory applications such as ND, SND, and FDC applications through the SUGAM portal for domestic manufacturing approvals, marketing authorization, and clinical trial permissions.
Labeling and Prescribing Information Review
Review draft labels, packaging materials, and specimen labels for regulatory compliance.
Prepare prescribing information by referencing approved international prescribing guidelines.
Documentation and Compliance Management
Ensure all regulatory documentation meets national regulatory requirements and internal quality standards.
Maintain organized records of regulatory submissions and documentation for audit readiness.
Educational Qualifications
Master’s Degree in Pharmacy (M.Pharm) or a related pharmaceutical sciences discipline.
Experience Requirements
8–10 years of experience in regulatory affairs within the pharmaceutical industry.
Strong experience in Indian regulatory submissions, dossier preparation, and regulatory documentation review.
Key Skills
Indian Regulatory Affairs Expertise
Strong understanding of Indian regulatory guidelines and pharmaceutical approval processes.
Regulatory Documentation and Dossier Preparation
Experience in preparing and reviewing regulatory dossiers including CMC, clinical trial, and bioequivalence documentation.
SUGAM Portal and Regulatory Submissions
Hands-on experience with regulatory submissions through the SUGAM portal.
Scientific and Regulatory Research
Ability to conduct literature reviews and develop scientific rationales for regulatory submissions.
Cross-Functional Collaboration
Strong coordination skills to work effectively with R&D, clinical, and regulatory teams.
Communication and Documentation Skills
Excellent technical writing and regulatory documentation capabilities.
Additional Information
This role is based at Sun Pharma’s R&D facility in Vadodara and involves close collaboration with internal departments to support regulatory approvals and product registrations in India.
Equal Opportunity Employer
Sun Pharmaceutical Industries Ltd. is committed to providing equal employment opportunities and fostering a diverse and inclusive workplace environment for all employees.
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