Senior Manager, Regulatory Affairs

Senior Manager, Regulatory Affairs

Daiichi Sankyo Europe

Uxbridge, United Kingdom

Accountabilities/Measures:

• For an assigned product portfolio, act as the regulatory liaison and contact person for the MHRA, support or lead negotiations on regulatory issues and organise meetings and teleconferences;
• In close collaboration with the UK, European and Global Regulatory Team develop regulatory strategies and advice, and provide clear guidance and information to internal and external stakeholders on behalf of Daiichi Sankyo;
• In collaboration with the European and Global Regulatory Team plan, lead and manage regulatory submissions to MHRA during product development and lifecycle management;
• Advise on national submission matters and any specific additional national requirements, identify deficiencies requiring resolution. Prepare gap analyses of UK documentation vs. EU and global requirements;
• Provide launch support and advise on supply questions of medicinal products to patients;
• Maintain licences of approved products, initiate and supervise implementation of changes; provide oversight and ensure regulatory compliance. Keep the European headquarters informed about the status of submissions and implementation of changes;
• Independently manage coordination and preparation of regulatory documents for UK submission, review regulatory and related documents for sign off prior to submission. This includes any national documents required for submission and for labelling and artwork implementation;
• Act as the regulatory liaison for the Daiichi Sankyo UK affiliate for a designated product range (and/or UK alliance partners). Act as the primary contact person for regulatory information and support. This includes Brand Teams, Medical, Market Access and Supply;
• Where required, support regulatory activities and submissions in Ireland, e.g. as absence cover;
• Work with the European Regulatory Team and Clinical Research Organisations to provide regulatory advice on matters related to interventional and non-interventional clinical trials in UK if needed;
• Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives with particular focus on UK/MHRA national regulations. Communicate important changes and trends within Regulatory Affairs and UK affiliate business functions when relevant;
• Represent Regulatory Affairs and/or DS in internal and external interactions and liaise with functional groups at UK Affiliate, multidisciplinary local and multinational project and working teams, licence partners, authorities, and industry associations. Build up strong relationship with internal and external stakeholders at the UK affiliate and EU head office;
• Where applicable, mentor/instruct and provide guidance to internal and external reports including consultants and service providers. Plan, assign and direct work; manage competing priorities as appropriate;
• Lead or support projects to enhance the functionality and improve processes of the organisation and/or to adapt to a regulatory environment. Design and revise SOPs and SOIs if required;
• Contribute to continuous process improvements and inspection readiness for both internal process reviews/audits and HA inspections for GxP.

Technical/Professional Knowledge:

Essential

• Degree in Pharmacy, Medicine, Life or Natural Sciences;
• Deep knowledge of UK/MHRA national laws, regulations, guidelines and other requirements for human medicinal product marketing authorisation and maintenance is essential;
• Significant level of experience (circa +5-8) years professional background in pharmaceutical industry, in Clinical Research Organisations or at a regulatory authority with + 5 years proven experience in Regulatory Affairs with an emphasis on regulatory pre-submission and post-approval activities and preparation of new marketing authorisations in the UK and EU;
• Understanding of development and life-cycle management of drugs and regulatory processes including the regulatory requirements and processes in the UK and Europe. Ability to interact and communicate effectively with regulatory authorities and external stakeholders;
• Working experience with MHRA;
• Very high ethical standards;
• Excellent interpersonal skills. Ability to communicate and work across functions effectively in a multinational organisation to accomplish results;
• Be detailed-oriented, well organised and self-motivated. Proven ability to plan, coordinate and lead activities simultaneously on multiple projects;
• Computer proficiency (e. g. MS office, document management systems, databases), excellent written and verbal communication skills in English.

Desirable

• PhD, post-doctorate or professional experience in pre-clinical research or clinical development, a TOPRA diploma or Master’s degree in Regulatory Affairs or other relevant specialisation;
• Experience in Oncology, including Project Orbis;
• Fluent in another European language.

Apply Now