Raina Supriya

Regulatory Affairs Project Manager with over 8 years' experience in the pharmaceutical industry, specialising in lifecycle management and regulatory strategy across generic, OTC and prescription medicines. Skilled in leading complex, cross-functional projects, managing high-volume variations, and ensuring compliance across UK and EU markets. Track record of streamlining regulatory processes — including a 15% reduction in dossier compilation time — and consistently delivering against critical CCSI/PRAC milestones under tight timelines.

Currently available following a redundancy at Perrigo, and looking to bring this expertise to a new regulatory affairs role.

Regulatory Affairs Project Manager - Perrigo Pharma PLC - Leeds, UK

(2023-03 - 2026-08)

• Spearheaded the regulatory strategy for a Nicotine 1mg licence, authoring the briefing document and representing the company at a Scientific Advice Meeting with the MHRA, securing written advice in October 2024; the product is now progressing through bioequivalence (BE) studies ahead of launch.
• Orchestrated the regulatory workstream for the Galpharm All-in-One project over several years, collaborating with R&D, Quality, and Commercial departments through to its launch in August 2025.
• Directed lifecycle management for over 50 generic and OTC projects, conducting nitrosamine risk assessments across 5 licences and managing high-volume Type I/II variations, renewals, and safety-driven SmPC/PIL updates.
• Served as the primary regulatory liaison among R&D, Artworks, QA, and Commercial teams, ensuring comprehensive input capture prior to submissions and packaging changes.
• Mentored team members on regulatory processes and day-to-day delivery; earlier in the role, undertook due diligence on new markets and products, including research into the International Recognition Procedure (IRP).
• Optimised the Technical Data-to-Regulatory handoff process, reducing average dossier compilation time by 15%.
• Received consistent recognition from leadership for reliably meeting CCSI/PRAC milestones and launch dates under stringent timelines.

Regulatory Affairs Associate - Thornton & Ross Limited - Huddersfield, UK

(2019-06 - 2023-03)

• Prepared and technically upgraded eCTD dossiers for national prescription and generic medicines, meticulously reviewing CMC documentation to ensure alignment with current requirements.
• Oversaw the review of technical data during a licence-transfer project that integrated a range of prescription medicines from a global partner into the company's portfolio, and harmonised 12 medical device dossiers to comply with MDR requirements.
• Managed complex Type I/II variations under Mutual Recognition (MRP) and Decentralised (DCP) procedures, including super-grouping and work-sharing variations across multiple licences and markets.
• Engaged directly with the MHRA and HPRA to resolve technical queries during variation assessments.
• Revamped outdated regulatory SOPs and eliminated redundant steps in the artwork and labelling review process, achieving a 20% reduction in approval delays.

Regulatory Associate (Maternity Cover) - Perrigo (Rosemont Pharmaceuticals) - Leeds, UK

(2018-05 - 2019-05)

• Compiled and maintained Drug Master Files (DMFs) and CMC documentation within strict GxP and GMP environments.
• Generated and updated comprehensive eCTD dossiers (Modules 1–5) utilising T.V.T and Samarind software.
• Prepared and coordinated Article 61(3) notifications, BROMI requests, and variations under National and Decentralised Procedures for a diverse portfolio of licensed prescription products.

Regulatory Affairs & Quality Executive - Neopharma LLC - Abu Dhabi, UAE

(2005-07 - 2008-07)

• Ensured adherence to international medicines regulations for an extensive export portfolio of prescription pharmaceuticals.
• Authored scientific justifications and technical responses to address regulatory authority challenges during product evaluation processes.
• Drafted and audited original SOPs for regulatory and quality control operations, ensuring manufacturing protocols were aligned with international standards.

Research Fellow - Council of Scientific and Industrial Research (CSIR) - Jammu, India

(2000-03 - 2005-04)

• Executed experimental protocols for drug discovery initiatives, focused on drug-transport, toxicity, and hepatoprotective mechanisms; co-authored a peer-reviewed publication in Hepatology Research on anti-tuberculosis drug-induced hepatotoxicity.

Masters Diploma - Pharmaceutical Management - Institute of Pharmaceutical Education and Research (IPER) Pune, India

BPharm (Hons.) - Pharmacy - Shivaji University Maharashtra, India