Regulatory Affairs Manager (CTA)

Description:

PE Global is recruiting a Regulatory Affairs Manager (CTA) for our multinational pharmaceutical client based in Uxbridge. The role is hybrid and an initial 12-month contract.

Responsibilities of the role:
• Advising the GRT on regional considerations in developing strategy
• Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
• May manage one or more regional leads or support roles
• May participate as a member of: Global Regulatory Team (GRT) Global Development Team (GDT) Clinical Study Team (CST) Label Working Group (LWG) Regional Teams (e.g. IMT, IBT, NAMT)
• Act as a contact with relevant regulatory agencies in fulfilling local obligations.
• Under general supervision participates in core regulatory activities to ensure effective regional agency interactions.
• Review and approve materials for use in the EU.
• Strategy and Execution Plans and manage regulatory submissions.
• Implement product related regulatory strategies, Regulatory Affairs processes and activity planning.
• Manage in the development of the regional product label with the Labelling Working Group.
• Supports regional label negotiation activities, participate in the development and execution of regional regulatory product strategies.

Requirements:
• Working with policies, procedures and SOPs
• Knowledge of relevant legislation and regulations relating to medicinal products
• Awareness of the regulatory procedures in region for MAs, CTAs, post approval changes and amendments, extensions and renewals.
• Knowledge of drug development Cultural awareness and sensitivity to achieve results across both regional country and international borders.

Interested candidates should submit an updated CV.
Please click the link below to apply, call Sean on (phone number removed) or alternatively send an up to date CV to
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***

Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert