Regulatory Affairs Senior Manager
An international biopharmaceutical company is currently recruiting a Regulatory Affairs Senior Manager based in the UK. This is an exciting opportunity to bring expertise and skills to an established and in-demand company that is focused on improving patients' lives by identifying, developing and commercialising meaningful products that address unmet medical needs.
- Leading cross-functional teams for new ROW registrations, as well as managing the on-going life-cycle maintenance activities for assigned products covering ROW markets.
- Regulatory filing and life-cycle maintenance activities will also be coordinated in collaboration with in-country partners.
- Executing the regional regulatory strategy pertaining to the development, registration and regulatory compliance of company products in the ROW markets as dictated by company business objectives. This will include:
- Interacting with the relevant groups as needed to ensure timely submission and approval for company products in these markets.
- Providing regulatory support and expertise for the ROW (AsiaPac, LATAM, MENA) portfolio of products.
- Ensuring ROW filing strategy is appropriately represented within the Global Regulatory Team (GRT) and at other appropriate forums (Global Development Team etc.)
- Leading and managing more junior roles, as required.
Skills and Requirements:
- Bachelor's degree required (Scientific discipline preferred) or equivalent in industry related experience.
- Minimum of 7 years' experience in the pharmaceutical industry, with minimum of 5 years direct experience in ROW registration activities.
- Planning & management of all allocated projects and ensuring timely delivery of these projects.
- Collaborate with cross-functional team to develop and implement regulatory strategies based on organisational priorities and resource availability.
- Ability to work cross-functionally and in collaboration with key internal stakeholders/customers (e.g. commercial, technical, quality, medical, supply chain etc.)
- Working knowledge of regulatory requirements and cultural differences for various country registrations and maintenance activities (e.g. local regulatory partners, local distributors and MA holders, regulatory agencies).
- In addition to working in cross-functional teams, must also be able to work successfully as an individual contributor, with a high level of professionalism.
- Proven experience in regulatory affairs with focus on initiating and managing new ROW registrations and life-cycle maintenance activities (e.g. Variation applications including new indications, Renewals, PSUR submissions, Notifications, MA transfers, MA cancellations).
- Act as contact point/knowledge base for scientific & technical aspects of Module 1 documents and associated regulatory activities.
- Ensure compliance with product post-marketing approval requirements.
- Timely filing of complete, high quality regulatory submissions; prompt, complete and accurate management of responses to Health Authority questions and effective communication of approvals.
- Ensure that all submissions comply with the current regulatory guidelines and legislation at all times.
- Ability to review regulatory documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies.
- Ensuring 100% accurate and complete archiving of all submissions, approvals and regulatory agency correspondence performed in ROW markets.
- Ensuring that regulatory document management system contains the most current and accurate information.
- Excellent verbal and written communication skills and collaborative interpersonal skills.
- Ability to travel occasionally - approximately 10-20% regional and/or international travel.
- Responsibilities may require working outside of "normal" hours, in order to meet business demands.
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 Roberto Esposito at 0203 761 5702 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.