Muhammad Bashir
Senior Regulatory Executive @GSK
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WORK HISTORY
Senior Regulatory Executive @GSK
Brentford, GB
Provide regulatory advice and support in the small molecules mature products respiratory team. • Formulate regulatory implementation strategy plans for global post approval CMC changes impacting the US, Australia, Canada and international markets. • Coordinate and respond to Health Authority questions from the US FDA, Health Canada, Japan PMDA and Vietnam DAV. • Preparation of high quality CMC detailed regulatory documents in line with strategic plans using varied information sources, liaising closely with other GSK personnel (manufacturing, Local Offices) to support submissions in Algeria (MAA), Canada (DMF conversion), Indonesia (MAA), Japan (Paediatric JNDA) and the US FDA (Annual Reports). • Work to agreed deadlines and maintaining records to reflect project status. • Responsible for highlighting potential delaying factors promptly to line management and sharing knowledge of regulatory documentation and procedures with others to assist in problem solving. • Proactively pursue process improvement and share best practice with manufacturing and regulatory colleagues globally. Key Achievements: • Presented a global regulatory strategy for gaining approval of clinical indications for existing and new MAAs to fellow regulatory professionals at a TOPRA Module on Regulatory Strategy for Established Active Substances. • Presented and coordinated a regulatory implementation strategy plan to the regulatory department for global post approval CMC changes involving 19 API’s and 21 international markets.
EDUCATION
The Manchester Metropolitan University
BSc (Hons), Chemistry
University of Wales, Cardiff
Postgraduate Diploma, Regulatory Affairs
ABOUT MUHAMMAD BASHIR
A highly skilled regulatory affairs professional with 21 years experience in the pharmaceutical industry; 16 years in regulatory and 5 years in R&D, QC and QA. Bulk of my regulatory experience is CMC but also includes clinical and labelling updates to support additional indications in a variety of therapeutic areas - HIV, liver disease, oncology, fertility, cardiovascular, respiratory. Proven track record of formulating regulatory implementation strategy plans and delivering high priority quality submissions in the EU (10+yr), UK (4yr) and Rest of World (RoW, 9+yr). Good ability to strategically plan, author and execute submission packages to meet tight deadlines and company targets. I\'ve demonstrated effective leadership and project management skills to organise, influence and negotiate cross-functionally with other teams. I have experience of interactions with Regulatory Authorities, especially in MENA and the MHRA. I have good familiarity with international market regulations and strong problem solving and analytical skills for reviewing and assessing technical data. I enjoy developing junior regulatory trainees in the Regulatory Affairs profession and working as part of a team and independently.
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