Associate Director Regulatory Affairs
hace 3 días
Hammersmith
Job Title: Global Regulatory Lead (GRL), Senior Regulatory Program Manager Job Type: Full-time permanent position Location: West London, UK – 3x a week in the office Salary: Attractive salary plus benefits package Working for one of the industry’s leading pharmaceutical companies, this is a fantastic opportunity to provide expert regulatory knowledge from pre-clinical through clinical studies to initial registration in key global markets. Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies. Interacts and negotiates with regulatory agency personnel in order to expedite approval of pending registration and answers any questions. Serves as a regulatory liaison on the project team throughout the product lifecycle. Ensures rapid and timely approval of new drugs, biologics/biotechnology, and/or medical devices, and continued approved status of marketed drugs or medical devices. Serves as regulatory representative to marketing or research project teams and government regulatory agencies. Provides advice to development and/or marketing teams on manufacturing changes, line extensions, technical labelling, appropriate regulations, and interpretations. Coordinates, reviews, and may prepare reports for submission. Role responsibilities: • Drive global Regulatory Affairs strategies for the portfolio, including managing internal and external stakeholders., • Lead interactions with the health authorities/ local agencies – MHRA, EMA & FDA. This will be including pre-submission meetings, pre-IND meetings, Scientific advice and type B/C meetings with the FDA., • Support both early and late-stage development activities CTAs, IND, ODD, PIPS, IND, IMPD, and initial MAAs., • Confident in doing submissions in global markets with a main focus on the UK, EU, US, and ROW., • Support and lead cross functional team discussions with medical, quality, PV, and other departments. Requirements: • A scientific degree is essential., • Proven track record of leading successful European (CP, DCP, MRP), European national and US submissions., • Confident in leading global RA strategies., • Knowledge of regulatory frameworks and external environments as it applies to project specific global regulatory strategy document (GRSD) delivery., • Ability to drive new regulatory approaches to improve and expedite development products submissions to meet business/project objectives and patient needs., • Ability to clearly convey and exchange information with internal and external stakeholders. This role is a very senior role within the regulatory team and within any other business, it may be titled an Associate Director. You will need at least 8 years of relevant regulatory experience, ideally within a large pharmaceutical business. All the Regulatory team members attend the office 3x a week, so you would be expected to attend the office on a hybrid basis in White City, London. For more information, please reach out to me at
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