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Regulatory Affairs Manager - UK and Ireland
- Contract
- Project Manager
- United Kingdom
This vacancy has now expired. Please see similar roles below...
Proclinical are recruiting for a Regulatory Affairs Manager - UK and Ireland to join a pharmaceutical organisation. This role is on a contract basis and is located in London.
Responsibilities:
- Distribute and uphold competitive licenses for UK which involves driving regulatory method for new initiatives.
- Distribute clinical trial approvals and upkeep of high regulatory compliance standards for UK accomplished through provision of local regulatory knowledge in a timely manner.
- Assist with the development of the company's investigational and in-licensed/co-development products through valued contributions to MC3 products, study feasibility questionnaires, scientific advice meetings and any other linked actions.
- Responsible for full compliance with CRP needs aligned with the local quality management system SOP and any other company policies and standards.
- Other duties may be assigned to this role.
Key Skills and Requirements:
- Demonstrable experience working in a regulatory affairs organisation within a UK-based or international pharmaceutical organisation.
- Familiarity with operational regulatory within a pharmaceutical organisation in a commercially aware role.
- Negotiation abilities with computer literacy.
- Knowledge in one of the following therapeutic area illnesses or technology fields: Respiratory, Cardiovascular, Diabetes, Renal, Oncology, injectable biologics, inhaled medicines, medical devices.
Acquaintance with producing and distributing regulatory methods for orphan drugs applications and/or paediatric indications.
If you are having difficulty in applying or if you have any questions, please contact Peter Duvall on p.duvall@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
#Regulatory
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