Asset Regulatory Lead (Strategy)
ProClinical have a new vacancy at a pharmaceutical company that specialises in the research and development of highly effective and innovative medications. This job vacancy is for an Asset Regulatory Lead (Strategy) position with their team at their Cambridge office. The company is one of the industry's most well-known brands and specialises in R&D in 3 major areas; respiratory, oncology and inflammation.
- Developing and leading regulatory strategies and driving the execution of registration plans for development, regulatory approval and optimal regulatory data protection/market exclusivity (RDP/ME), and market access of early and late stage development assets in the assigned regions.
- Providing regulatory advice and expertise to R&D, commercial asset teams, business development, alliance partners, and other activities related to innovating, developing and enhancing the value of pipeline.
- Providing specialist advice and expertise in specific technical regulatory areas CMC, labelling or LCM to support regulatory strategy and execution.
- Providing regulatory expertise for the development asset portfolio utilising optimised regulatory pathways and submission routes to achieve strong commercially focussed labels and expeditious approvals that maximise RDP/ME.
- Defining regulatory pathways and strategic options, ensuring alignment and driving regulatory recommendations within the asset team and other parts of the business, as part of an integrated drug development plan for pre-IND through to MAA assets in key territories, including development of new indications.
- Leading the development, documentation, and review of the Strategic Regulatory Plan for the assigned assets including assessment of the probability of regulatory success together with risk mitigation measures; utilise available resources including outsourcing partners to efficiently deliver regulatory milestones in accordance with the plan
- Maintaining ownership and accountability for timely and effective Regulatory Agency negotiations and interactions throughout the asset development and registration process.
- Driving regulatory outcomes and local delivery in the Independent associated Companies (IACs) in line with development & commercial goals through optimal partnership with IACs
- Responsible for regulatory representation in Alliance Management with Partner Companies for their assigned assets.
- Providing strategic direction and oversight of delivery output from outsourcing partners to ensure alignment with regulatory strategies, effective execution and quality submissions, and regulatory agency interactions.
- Providing strong regulatory expertise into assigned Due Diligence for new assets, ensuring a solution-based focus to give key regulatory considerations and regulatory direction for business development.
- Providing expertise in particular regulatory focused disciplines (CMC, labelling, LCM) to support early and late stage and life cycle management assets in development.
Skills and Requirements:
- At least an undergraduate degree.
- Relevant experience in a similar, or related, field.
- Excellent project management, consensus building, and leadership skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Alex Czuprynski at +44 203 869 2329 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
£0.00 - £40000.00 per annum
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