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We are currently looking for a Head of Regulatory Affairs to join a leading Pharmaceutical company based in the Berkshire area. As the Head of Regulatory Affairs you will be responsible for supporting registrations with all existing products in their portfolio, as well as ensuring all new products are developed in line with the company's global regulatory strategy.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Head of Regulatory Affairs will be varied however the key duties and responsibilities are as follows:
1. You will be the regulatory leader for all matters and will take the responsibility for developing the companies regulatory strategies for all development projects, manufacturing improvements and the continued registration and licensing for all established products both in current markets, and new.
2. You will act as a the point of contact with regards all regulatory interactions. This will include preparing all pre and post meeting strategies and responses as well as
3. As the Head of Regulatory Affairs you will manage the preparation of registration dossiers and submission of Marketing Authorisation Applications (MAAs) in line with regulatory authority requirements. To do so you will interact with all licensing partners to ensure submissions of MAAs in their territories are be successful.
4. Additional duties of the role will be to lead the team on all artwork, labelling ensure all manufacturers / importers and wholesale dealer licensee are maintained, as well as the regulatory compliance with all change controls and SOP activities.
To be successful in your application to this exciting opportunity as the Head of Regulatory Affairs we are looking to identify the following on your profile and past history:
1. Relevant degree in a life sciences related field (Biological Sciences, Pharmaceutical Chemistry, Quality Management etc) with proven experience in leading global Regulatory Affairs strategy in a Pharmaceutical company.
2. Experience with regulatory affairs within a development, research or establish product portfolio environment will be welcomed, provided you can demonstrate clear evidence in the leadership around delivering Regulatory strategy's in an EU or global basis, and leading a team.
3. A working knowledge and practical experience with managing products through CP / DCP / MRP and National as well as exposure to working in a clinical trial environment, would be expected.
Key Words: Pharmaceutical Regulations / Global Regulatory Affairs / EU Regulations / Head of Regulatory Affairs / Director of Regulatory Affairs / Pharmaceutical Licensing / New Product Development / Global Pharmaceutical Strategy
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors and is made up of a collaboration of scientists supporting science. We look forward to helping you with your next career moves.