Rahul Walunj
Airoli (Navi Mumbai)
Summary
Experienced Regulatory Affairs Manager with a robust background in managing end-to-end regulatory compliance for FMCG and pharmaceutical products across global markets. Demonstrated expertise in FSSAI licensing, CDSCO/DCGI submissions, and CTD/eCTD dossier compilation. Proven track record in ensuring ingredient, additive, formulation, and claims compliance, as well as overseeing post-approval lifecycle management. Adept at coordinating with cross-functional teams to meet regulatory timelines and support business continuity.
Career goal: to leverage extensive regulatory affairs experience to drive compliance excellence and support product innovation in a dynamic organization.
Overview
14
14
years of professional experience
Work History
Manager- Regulatory Affairs
Procter & Gamble Health Limited
Mumbai, India
07.2018 - 04.2025
- Led end-to-end FSSAI regulatory compliance for large-scale FMCG food manufacturing operations, including Central & State licenses for plants, warehouses, and contract manufacturers.
- Ensured ingredient, additive, formulation, and claims compliance in line with FSSAI regulations and evolving notifications.
- Reviewed and approved high-volume food labeling and packaging artworks, ensuring compliance with nutrition, allergen, statutory, and legal metrology requirements.
- Managed regulatory activities for semi-regulated markets including Sri Lanka, Nepal, Maldives, and Myanmar, ensuring product registration and continued compliance.
- Drafted and managed health authority communications, submissions, responses to queries, and follow-ups.
- Oversaw post-approval lifecycle management including renewals, quality updates, and safety changes for assigned markets.
- Coordinated with business partners, third-party consultants, and cross-functional teams to meet regulatory timelines and support business continuity.
- Supported customs clearance of ingredients and finished products from a regulatory compliance perspective.
- Actively collaborated with Marketing on promotional material and artwork reviews to ensure regulatory compliance.
Deputy Manager – Regulatory Affairs
Cipla Limited
Mumbai, India
10.2013 - 07.2018
- Managed global regulatory submissions for respiratory and non-respiratory products across Russia-CIS, WANA, GCC, ASEAN, LATAM, Africa, and Asian markets.
- Planned, compiled, and submitted CTD and country-specific dossiers, including Module 3 (Quality) documentation.
- Developed regulatory strategies for new product registrations, renewals, and line extensions in ROW markets.
- Conducted gap analyses for renewals and variations to ensure uninterrupted product approvals and market continuity.
- Prepared and coordinated responses to regulatory deficiencies and MOH queries in collaboration with R&D, Manufacturing, QA, and regional teams.
- Maintained regulatory trackers and databases to monitor submission status, approvals, and commitments.
- Supported implementation of regulatory IT systems (CipDox, Documentum, TrackWise) to strengthen regulatory processes and compliance.
QA Officer
Johnson and Johnson
Mumbai, India
03.2012 - 10.2013
- Ensured GMP, GDP, and GLP compliance during manufacturing and packaging operations.
- Performed line clearance, in-process checks, and review of BMR/BPR documentation.
- Participated in deviation investigations, OOS handling, and CAPA implementation.
- Supported quality systems using LIMS and SYMPHONY.
- Managed the documentation of all quality assurance activities, facilitating easy reference and compliance.
- Analysed data from quality tests to identify trends and areas for improvement.
- Monitored compliance with regulatory requirements to mitigate risks and uphold company reputation.
- Monitored the effectiveness of corrective actions to ensure continuous quality improvements.
QC Officer
WOMCO Laboratories
11.2008 - 08.2009
- Managed ETO sterilization processes, cycle monitoring, and microbial testing.
- Performed wet chemical analysis and ensured GMP/GLP compliance.
Trainee
Cipla Pvt. Ltd
Mumbai, India
07.2008 - 11.2008
- Reviewed regulatory and legal documents, COAs, BMRs, and compliance documentation.
- Supported dossier compilation and regulatory documentation for ROW markets.
- Acted as key compliance contact and officer for regulatory matters, answering queries promptly and politely.
- Built and maintained strong working relationships across company to help implement internal standards.
- Maintained a comprehensive database of compliance records, audits, and corrective action plans for easy retrieval.
Education
Master of Pharmacy - Pharmaceutical Chemistry
Bombay College of Pharmcay
santacruz2012
Bachelor of Pharmacy - Pharmacy
NCRD's Sterling Institute of Pharmacy
Nerul2008
HSC - IT
Motilal Hargovidadas High School
Thane, Maharashtra2004
Skills
- Regulatory Affairs Strategy (India & ROW)
- CDSCO / DCGI & State FDA Submissions
- FSSAI Licensing & Compliance
- CTD / eCTD Dossier Compilation (Module 3)
- WHO-GMP & Schedule M Compliance
- New Product Registration & Line Extensions
- Post-Approval Lifecycle Management (Renewals, Variations)
- Global & Emerging Markets (CIS, GCC, ASEAN, LATAM)
- Labeling, Artwork & Claims Compliance
- Regulatory Intelligence & Audit Support
Languages Known
English
Hindi
Marathi
Custom Section
- NS3 a potential target on Dengue virus, Delivered seminar in Bombay College of Pharmacy
- Research work presented in IBS 2012, Chennai
- Attended national seminar on Drug Discovery & Development, Bombay College of Pharmacy, 2009-10-01
Disclaimer
I hereby declare that all the information given by me is true to the best of my Knowledge., 2024-01-22, Navi Mumbai
Interests
- Regulatory updates and compliance learning
- Research reading and knowledge building
- Process improvement and documentation
- Health, fitness, and wellness
- Travel and cultural exposure
Additional Qualification
Diploma in Dietetics and Nutrition - From Dr. D. Y. Patil College, Nerul
Knowledge of nutrition science, dietary requirements, ingredient functionality, and health & wellness principles, supporting FSSAI compliance, nutritional labeling, claims assessment, and consumer healthcare product alignment.
Timeline
Manager- Regulatory Affairs
Procter & Gamble Health Limited
07.2018 - 04.2025
Deputy Manager – Regulatory Affairs
Cipla Limited
10.2013 - 07.2018
QA Officer
Johnson and Johnson
03.2012 - 10.2013
QC Officer
WOMCO Laboratories
11.2008 - 08.2009
Trainee
Cipla Pvt. Ltd
07.2008 - 11.2008
Master of Pharmacy - Pharmaceutical Chemistry
Bombay College of Pharmcay
Bachelor of Pharmacy - Pharmacy
NCRD's Sterling Institute of Pharmacy
HSC - IT
Motilal Hargovidadas High School