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OBJECTIVE

Accountable for leading the development and implementation of the global regulatory strategy for current and future products. Ensure that the strategy is designed to deliver rapid approval with advantageous labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients.

KEY ACCOUNTABILITIES

Lead the regulatory team, provide leadership and participate in skill-development, coaching, and performance feedback
Develops regulatory strategies for planned projects and manufacturing improvements, analyses risk vs. benefit in regulatory strategies to ensure successful review by regulatory authorities
Negotiates submission data requirements and deliverable dates with regulatory authorities and internal technical teams
Authors, with other team members, key pieces of regulatory submissions
Liaises with licensing partners or affiliate companies to ensure submissions of marketing authorisation applications in their territories can be successful
Acts as a point person for regulatory agency interactions, including preparation of briefing packages and strategy for meetings, inspections, advisory committee meetings, responses to agency letters pertaining to the assigned products/teams
Manages the routine Marketing Authorisation maintenance activities DCP/MRP/National including compilation and submission of variations and renewals
Manages distributors to ensure Marketing Authorisation compliance and to ensure timely submission
of variations and renewals, including translations
Evaluates manufacturing and labelling changes, liaising/advising other internal departments regarding implementation timelines and data requirements - accurately describes these changes for ease of regulatory agency review
Ensures new and post-approval product artwork is generated in line with regulatory requirements and to agreed timescales
Ensures Manufacturer’s / Importer’s Authorisations and Wholesale Dealer’s Licences are maintained in line with changing business requirements
Accountable for regulatory compliance to include the raising of regulatory Change Controls and the maintenance of regulatory SOPs
Supports due diligence of potential acquisitions

SPECIFICATION (Skills required to perform the job)

A Life Science degree or equivalent
Significant experience in the pharmaceutical industry, including medicinal and medical device regulatory development and life-cycle maintenance activities
Must have previous experience in leading Major Health Authority interaction
Proven leadership and program management experience
A scientific and clinical understanding of the regulatory sciences
Ability to think strategically and critically evaluate risks to regulatory activities
Excellent knowledge of applicable EU Regulations, Directives and Guidance
Experience of managing a product through the DCP/MRP/National approval processes
Exceptional organisational skills including the ability to prioritise effectively
Must demonstrate competencies of: strategic thinking, strategic influencing, innovation, collaborative working, initiative, leadership and excellent oral and written communication skills
Must be able to commute to the office 3x per week (Monday, Tuesday and Thursday)

Britannia Pharmaceuticals Ltd

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