Varsha Divekar在找工作

Manager Regulatory Affairs in Pune @ Brinton Pharmaceuticals Ltd.

About

Regulatory Affairs professional with 11+ years of experience in Pharmaceuticals, Vaccines, Nutraceuticals and Cosmetics. Skilled in global dossier submissions (CTD, ACTD, VNeeS, PIF) and regulatory compliance across EU, USA, UK, ASEAN, LATAM and African markets. Currently working as Manager – Regulatory Affairs, leading a 4-member team and expert in product registrations, variations and digital marketing compliance. Maintain the compliance of products label, formulations by evaluating ingredients & claims as per health authority. Review & approval of Artworks & brand communications as per Regulatory guidelines.

Country

India

City

Pune

Industry

Pharmaceuticals

Skill

Renewals, Adobe Acrobat, Query Resolution, Variation , Artwork, Regulatory Approvals, CMC Regulatory Affairs, Variation, Publications, Dossier Preparation, Document Review, GMP application, International market , Microsoft PowerPoint, ANDA, Pharmaceutics, HPLC, Regulatory Affairs, Regulatory Submissions, Regulatory Guidelines

Experience

Manager

Brinton Pharmaceuticals Ltd.

2024-4 - Present · 2 yrs 5 mos

Pune, Maharashtra, India

Assistant Manager

Brinton Pharmaceuticals Ltd.

2022-6 - 2024-3 · 1 yr 10 mos

Pune, Maharashtra, India

Regulatory Affairs Executive

Ventri Biological Vaccine Division

2017-8 - 2022-6 · 4 yrs 11 mos

Pune, Maharashtra, India

Preparation of registration & re-registration dossiers as per regulatory guidelines for vaccines & injectable products

Regulatory Affairs Executive

Cian Healthcare Pvt. Ltd.

2013-9 - 2017-7 · 3 yrs 11 mos

Pune Area, India

Compile the registration dossiers for various countries in CTD, A-CTD & Country specific guidelines. Coordinate with manufacturing unit for Technical Documents. Monitoring, control and Handling of technical queries raised by Regulatory Authority.

F & D Executive

Batavia Exports International LLP

2012-11 - 2013-9 · 11 mos

Pune

Handling Formulation Development & Regulatory affairs for Europe market(Generic Formulation). Handling projects of regulated & non regulated market(Tablets, capsules, Suspensions, Lozenges,Injectables) Coordination with factory, R&D, QA, QC, Packing, Production departments for analytical data requirement, Registration samples & Technical documents.