Regulatory Affairs Manager

Location

Hertfordshire | United Kingdom

Job description

Hobson Prior are currently looking for a Regulatory Affairs Manager to join a fantastic pharmaceutical organisation on a permanent basis located in Hertfordshire. Our client is focused on improving eye health and vision.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this role, you will uphold and attain marketing authorisations in EMEA region aligned with the company methods, business requirements and European regulatory needs.
• Provide senior knowledge of regulatory processes, develop and execute methods for regulatory processes and applications.
• Offer senior level expertise and strategic management on multifaceted regulatory applications.
• Handle regulatory lifecycle of allocated products, which involves maintenance of the regulatory core dossiers (Mod 1-5) for territory growth and lifecycle proposals and having an oversight of the allocated products regulatory status across EMEA.
• Collaborate with both internal and external partners and authorities to pursue and maintain Mas.
• Accountable for general regulatory execution strategy for major changes for designated products for EMEA.
• Other duties may be assigned.

Requirements:

• Demonstrable experience in European regulatory affairs.
• Know-how of the legislation of the EU for marketing authorisation procedures and processes, focusing on variations and renewals.
• Capable of arranging regulatory projects with both internal and external partners.
• Educated to a degree or higher level in a Pharmaceutical, Chemical or other Life-Science field.

Apply now :

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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Job tags

Salary

£55k - £65k per annum