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- Revamped outdated regulatory SOPs and eliminated redundant steps in the artwork and labelling review process, achieving a 20% reduction in approval delays.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.
