Jyotsna Ambre
Regulatory Affairs professional with experience in pharmaceuticals enabling uninterrupted product availability through my skills in regulatory submission, operations and compliance across the UK and European markets.
- Role
- Team Leader-regulatory Affairs, Uk & Europe at Cipla
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Jyotsna Ambre
I am skilled in overseeing large portfolios, with responsibility for 500+ marketing authorizations spanning 20+ countries in Europe and UK, while ensuring smooth product availability and adherence to public health and enterprise standards.A trusted partner to senior leadership and regulatory authorities, bringing strong knowledge of submission processes, cross-regional coordination, and early engagement with regulators. Experienced in supporting Heads of Regulatory with day-to-day deliverables, aligning teams, and embedding knowledge-sharing frameworks that improve efficiency and consistency in filings.Known for a disciplined yet adaptive approach, combining governance, continuous learning, and cultural awareness to help organizations anticipate regulatory changes, maintain compliance, and support sustainable business growth.My work experience includes: New MAA procedure management covering from slot booking until MA grant for Decentralized procedure, National Procedure, Mutual Recognition Procedure, Day Zero Repeat Use Procedure in EU, authoring of module 1, International Recognition Procedure in UK. Review and sign off Renewals, variations, Sunset clause, notification of marketing status applications, preparation of labelling as per QRD, blue box requirements, maintenance of MIA and WDA, change of ownership, ma transfer• Have represented RA in 03 Phv inspections for topic related to Reference Safety Information (RSI)• Have discussed and agreed with MHRA, a standard design for packaging in UK• Have led impact assessment and RA filings during implementation of- Falsified Medicines Directive, Year 2019- Brexit, March 2019 to Dec 2021- Windsor framework, Year 20••••25- F-gas regulation- Year 2025Day to day engagement with Regulatory Authorities.Day to day engagement with business and launch teams enabling uninterrupted product availability and adherence to complex EU frameworks.Hands on experience of submission through MHRA submission platform, CESP, Eudralink and SPOR.Day to day cross functional collaboration with Pharmacovigilance, packaging teams.Day to day management of team, training and recruitment.
Experience
Team Leader-regulatory Affairs, Uk & Europe
Dec 2012 — Present · Mumbai, IN
Responsible for submission and management of New Marketing Authorization Application and their maintenance through life cycle in UK and Europe.
Education
University of Mumbai
Bachelor of Science - BS
1995 — 1998
Skills
- Team Management
- Regulatory Requirements
- Regulatory Operations
- Regulatory Submissions
- Regulatory Affairs
- Ectd
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