Senior Manager Regulatory Affairs- UK & Ireland
5 days left
- Experience Level
Our client, an international pharmaceutical business, are in an exciting stage of portfolio expansion, adding to their traditional product offering with a rapidly developing Oncology department.
They now seek a Senior Manager of Regulatory Affairs for the UK & Ireland, who will provide regulatory guidance and execute regulatory activities for marketed products and development projects.
• Act as the regulatory liaison and primary contact for MHRA and HPRA, support or lead negotiations on regulatory issues.
• Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives. Design and revise SOPs and SOIs if required.
• Where applicable, mentor/instruct and provide guidance to internal and external reports including consultants and Clinical Research Organisations.
• In close collaboration with the European Regulatory Team develop regulatory strategies and advice and provide clear guidance and information to internal and external stakeholders.
• Advise on national submissions and evaluate the content and adequacy of regulatory submissions, identify deficiencies requiring further resolution.
• Provide and prepare national information and documents for submission including documents required for labelling.
• Ensure timely delivery of national regulatory submission, track and report national deadlines and submissions
• Maintain licences of approved products, initiate and supervise implementation of changes;
• Provide launch support and advise on supply questions of medicinal products to patients.
• Represent Regulatory Affairs in internal and external interactions and liaise with functional groups. Build up strong relationships with internal and external stakeholders at the UK affiliate and EU head office.
• Lead or support projects to enhance the functionality and improve processes of the organization.
- Degree in Pharmacy, Medicine, Life or Natural Sciences.
- Desirable but not essential: PhD, post-doctorate or professional experience in pre-clinical research or clinical development, a TOPRA diploma or Master Degree in Regulatory Affairs or other relevant specialization
- Deep knowledge of European and national laws, regulations, guidelines and other requirements for human medicinal product marketing authorization and maintenance is essential.
- Working experience in the pharmaceutical industry, in CRO, or at a regulatory authority with proven experience in regulatory affairs with an emphasis on regulatory pre-submission and post-approval activities and preparation of new marketing authorization in Europe and UK.
- Experience in oncology or rare disease
- Ability to communicate and work across functions effectively in a multinational organization to accomplish results.
- Detailed-oriented, well organized, and self-motivated. Proven ability to plan, coordinate and lead activities simultaneously on multiple projects.
- Very high ethical standards.
- Understanding of development and life-cycle management of drugs and regulatory processes. Ability to interact and communicate effectively with regulatory authorities and stakeholders.
- Computer proficiency (e. g. MS office, document management systems, databases) and excellent written and verbal communication skills in English.
- German and/or another European language is desirable.
This role can offer highly flexible home working, but regular visits to Middlesex office will be required for workshops and meetings. My client offers an interesting, diversified, and challenging position, good contractual conditions, flexible working models, all the social benefits of a modern company and a professional environment where you will have the opportunity for personal growth.
If you would like to discuss the roles in more detail, please contact Katie Dunbar on +44 (0)1239 584300 or apply using the button and you will be called back
Apply for Senior Manager Regulatory Affairs- UK & Ireland
Already uploaded your CV? Sign in to apply instantly