Regulatory Affairs Manager

CK Group are recruiting for a Regulatory Affairs Manager to join a biopharmaceutical company who are based in Cambridge, 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 Cambridge and offers hybrid/remote working.

Hourly Rate:

£43.94phr PAYE or £58.19phr Umbrella.

Role:

• Provide national/regional input to and execute regulatory strategies.
• Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.
• Contribute to the filing plan (MA and Lifecycle maintenance), advising and discussing with the local cross-functional team and with minimal supervision, executes the filing plan (MA and Lifecycle maintenance).
• Collaborate with Regional and Global Study Operations (GSO) teams to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements (where appropriate).
• Ensure local labels are developed and maintained in line with local legislation and create, review and approve source text for country labeling.  

Your Background:

• Educated to degree level or above in Life sciences or a related field.
• Extensive experience in Regulatory Affairs across the UK market and an understanding of the local regulatory procedures for CTAs, MAAs and all lifecycle management activities.
• Excellent communication skills and experience of building relationships with stakeholders 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 103571 in all correspondence.