Regulatory Affairs Manager - UK and Ireland

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