Department
:
Regulatory Affairs
Reporting to
:
Director of New Products, BD & Commercial Excellence
Location
:
Mumbai (on-site)
Experience
:
5+ years in Regulatory Affairs within pharmaceuticals/biotech, with demonstrated experience in CDSCO submissions
INSUD PHARMA operates across the entire pharmaceutical value chain, bringing specialist knowledge and experience in scientific research, development, manufacturing, sales, and commercialisation of a broad range of active pharmaceutical ingredients (API), finished dosage forms (FDF), and branded pharmaceutical products, adding value in both human and animal health. Our activities are organised in three synergistic business areas: Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with over 9,000 professionals in more than 50 countries. We are committed to innovation and sustainable development to deliver solutions that positively impact global health.
Exeltis, our branded pharmaceuticals division, focuses on therapeutic areas including Women's Health, Central Nervous System, and Cardiometabolic conditions, delivering high-quality branded generics, innovative molecules, and specialty products to patients worldwide.
We are seeking a Regulatory Affairs – Chief Manager to lead the regulatory strategy for Exeltis India's product portfolio—spanning branded generics, new chemical entities, fixed-dose combinations, and biosimilars—ensuring compliance with Indian regulatory requirements while aligning with global standards.
Regulatory Strategy & Compliance
Monitor changes in the Indian regulatory landscape (CDSCO, DCG(I), state FDA requirements), assess their impact on Exeltis India's portfolio, and propose solutions to maintain compliance
Define regulatory strategy for product registrations, line extensions, and lifecycle management in coordination with Management, Business teams, and global Regulatory Affairs
Interpret and communicate legislative changes under the Drugs and Cosmetics Act, New Drugs and Clinical Trials Rules 2019, and related guidelines affecting product registration, manufacturing, or development
Submissions & Approvals
Prepare, review, and approve regulatory submission documents including CTD dossiers, Form 44/45, clinical trial applications, marketing authorisation applications, and import licences as per Schedule Y and current CDSCO guidelines
Lead submissions for branded generics, new drugs, fixed-dose combinations, and where applicable, biosimilar products
Manage post-approval variations, renewals, and periodic safety update reports (PSURs)
Coordinate state-level licensing requirements (Form 20B/21B) for manufacturing and sales
Health Authority Engagement
Lead engagement with CDSCO during pre-submission meetings, Scientific Advice procedures, and responses to queries and deficiency letters
Coordinate with Subject Expert Committees (SECs) and manage timelines for New Drug Advisory Committee reviews
Build strong collaborative partnerships with CDSCO, state licensing authorities, and approved testing laboratories
Risk Management & Cross-Functional Collaboration
Identify and mitigate regulatory risks, adapting strategies to evolving regulations and Health Authority feedback
Support the review of licence agreements, site master files, and quality agreements for Indian operations
Collaborate with Quality Assurance, Pharmacovigilance, Medical Affairs, and Supply Chain teams to ensure compliant product launches
Support product launch activities, ensuring regulatory risks are managed with appropriate action plans
Operations & Digitalisation
Organise the regulatory submission schedule and coordinate with global Regulatory Affairs teams to align Indian filings with international timelines
Manage external consultants, CROs, and vendors for regulatory activities in India
Drive digitalisation within the department, including SUGAM portal submissions and electronic document management systems
Participate in product plan development, regulatory strategy, and CMC documentation in line with Indian Pharmacopoeia and ICH-aligned requirements
Qualifications
Bachelor's or master’s degree in pharmacy, Life Sciences, or a related discipline
5+ years of experience in Regulatory Affairs within pharmaceuticals or biotech, with hands-on experience in CDSCO submissions across multiple dosage forms
Strong working knowledge of the Drugs and Cosmetics Act 1940, New Drugs and Clinical Trials Rules 2019, CDSCO guidelines, and Schedule Y requirements
Experience with SUGAM online portal for regulatory submissions
Familiarity with ICH guidelines (CTD format) and their adaptation to Indian regulatory requirements
Experience handling branded generics, new drugs, FDCs, and/or biological products preferred
Excellent communication skills and ability to liaise effectively with CDSCO and state regulatory authorities
Experience managing external consultants and cross-functional project teams
Preferred Experience
Background in Exeltis therapeutic focus areas: Women's Health, CNS, or Cardiometabolic
Prior experience with import registrations and coordination with overseas manufacturing sites
Exposure to pharmacovigilance requirements and safety reporting in India
