Regulatory Affairs Manager

CK Group are recruiting for a Regulatory Affairs Manager to join a biopharmaceutical company who are based in Uxbridge on a contract basis for 12 months.

Company:

Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Location:

The role is based in Uxbridge and offers hybrid working.

Hourly Rate:

£45.56 PAYE.

Role:

• This role will support one or more products from a regional regulatory perspective and will achieve the desired labelling by developing and executing regional regulatory strategies and managing effective agency interactions.
• Ensure that all the required approvals are acquired and maintained in order to support clinical trials for investigational medicinal products as well as to market approved medicinal products.
• Advise on regional considerations in developing strategy and ensure that the regional needs are well defined and implemented in collaboration with relevant regional stakeholders.
• Act as a contact with relevant regulatory agencies in fulfilling local obligations by product assignment and document and communicate details and outcomes of regulatory agency interactions to senior management.
• Participate in core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy- including contingency regulatory planning/risk assessment.
• Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) in compliance with global filing plans and local regulatory requirements.
• Implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements and manage the development of the regional product label by collaborating with the Labeling Working Group.

Your Background:

• Educated to degree level or above in life sciences or a relevant field with significant experience in Regulatory Affairs in the pharmaceutical industry.
• Knowledge of regulatory procedures in region for MAAs, CTAs, post approval changes and amendments, extensions and renewals.
• Understanding of the drug development process as well as cultural awareness and sensitivity to achieve results across both regional country and international borders.
• Strong knowledge of relevant legislation and regulations relating to medicinal products.

Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 100750 in all correspondence.