Regulatory Senior Program Manager - Paddington, London (Hybrid)

Duties may include:

• Providing input to global program strategy, including working on new indications, new formulation, or acting as RA program lead for program of limited complexity.
• Responsible for developing and maintaining Core Data Sheet (CDS).
• Working closely with Health Authorities, including developing materials for meetings and interactions. Potentially serving as the project liaison for the FDA or EMA.
• Working on the planning and submission of clinical trials.
• Implementing global registration strategies and leading regional submissions on a global basis.
• Coordinating the submission of initial registrations and post-approval applications, including authoring of Module 1 documents.
• Responsible for meeting deadlines for submission of regulatory compliance and maintenance activities.
• Maintaining accurate information stored on in-house document management systems and tracker spreadsheets.
• Maintenance activities of regulatory submissions for assigned portfolio of products.
• Potentially examining client portfolios for divestment, M&A, site rationalization, or manufacturing production transfer.

• Life Sciences degree essential.
• Excellent communication skills – both written and spoken.
• Experience in all European procedures (MRP, CP, DCP) as well as direct contact with the Health Authorities is essential.
• As you will represent G&L to our clients and the agencies, interpersonal skills are paramount.
• Project and/or people management experience. This should include acting as a mentor to junior staff and developing individual training programmes.
• Experience working in client-facing environments.
• Experience in designing, running, and executing bespoke client projects.
• Experience spanning pharmaceuticals, consumer healthcare, biotechnology, and animal health products.
• Ability to work proactively with stakeholders and to communicate regulatory requirements and proposals.
• Must have experience in regulated markets, preferred with experience in emerging markets and international regions.
• Strong and proven project management abilities.