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Vedangi Kolhatkar

@vedangikolhatkar

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Regulatory Affairs professional specializing in eCTD submissions and product registrations.

South Africa

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What I'm looking for

I seek a remote Regulatory Affairs role where I can lead eCTD submissions, ensure global compliance, manage product registrations, and progress into a senior regulatory position.

I am a Regulatory Affairs professional with two years of hands-on experience in eCTD dossier preparation, pre- and post-registration submissions, new product launches, renewals, and compliance activities within a pharmaceutical manufacturing environment.

At Macleods Pharmaceuticals Ltd., I prepared Modules 1–5, compiled and published submissions via PharmaReady software, handled pre- and post-approval queries, managed variations (Type IA, IB, II, IN, Clinical), and supported packaging, labeling, and batch conversion processes to meet regulatory timelines.

I monitor regulatory updates, perform gap analyses, and contribute to product qualification records, renewals (PBRER, COPP, RMP), API DMF/CEP/CPQ/LOA-related submissions, and change control reviews; I seek a remote Regulatory Affairs role to drive efficient product registrations and grow into a senior regulatory position.

Experience

Work history, roles, and key accomplishments

Current

Junior Officer Regulatory Affairs

Current

Macleods Pharmaceuticals Ltd.

Prepared eCTD dossiers (Modules 1–5), managed pre- and post-approval submissions and queries, and supported new product launches and renewals to maintain regulatory compliance across markets including South Africa. Improved submission timeliness and managed artwork, labeling, and variation submissions (Type IA/IB/II/IN).

ECTD Compliance Regulatory Submissions Product Labeling & Artwork DMF CEP LOA Reviews Pharmacovigilance Regulatory Intelligence MS Office

Education

Degrees, certifications, and relevant coursework

SVKM's NMIMS - SPPSPTM

Master of Pharmacy, Regulatory Affairs

Grade: 8.15 CGPA

Master of Pharmacy (Regulatory Affairs) with a reported CGPA of 8.15, focused on regulatory submissions, post-approval variations, and dossier preparation.

Govindrao Nikam College of Pharmacy, University of Mumbai

Bachelor of Pharmacy, Pharmacy

Grade: 8.45 CGPA

Bachelor of Pharmacy with a reported CGPA of 8.45, covering pharmaceutical sciences and practical training relevant to regulatory and manufacturing environments.