Regulatory Affairs Senior Manager

1 week ago

Uxbridge, United Kingdom CK GROUP Full time

CK Group are recruiting for a Regulatory Affairs Senior Manager to join a biopharmaceutical company, who are based in Uxbridge and Cambridge on a contract basis for 6 months. This role is inside IR35, and allows for Remote working.
**Rates**:
Hourly: Up to £80 Umbrella
**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 geneticsto unravel the complexities of disease and understand the fundamentals of human biology.
**Location**:
The role is remote based position but the office team location is Uxbridge and Cambridge. Ideally you should be able to travel into the office occasionally for meetings.
**Regulatory Affairs Senior Manager**:
Ensure that the company acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as to market approved medicinal products to ensure timely regulatory compliance with above approvals,

**Responsibilities**:

- Advising on regional considerations in developing strategy ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
- Directs the development of the regional product label by collaborating with the Labelling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.

**Experience required**:

- Strategic guidance on filing strategies
- EU market / working with global teams
- Early development experience, with taking a product to market
- Post approval experience
- Paediatric plans and scientific advice

**Apply**:
It is essential that applicants hold entitlement to work in the UK. Please quote reference 54143 in all correspondence.

  • Senior Regulatory Affairs Manager EU Oncology

    2 weeks ago

    Uxbridge, United Kingdom Hays Careers Full time

    Senior Regional Regulatory Affairs Lead - Oncology (EU Markets)Your new company Are you a seasoned regulatory affairs professional with a passion for oncology and a deep understanding of European regulatory frameworks? Our client, a leading global biopharmaceutical company, is seeking a Senior Regional Regulatory Affairs Lead to drive regulatory strategy and...

  • Regulatory Affairs Manager

    2 weeks ago

    Uxbridge, United Kingdom Park Street People Full time

    An innovative global pharmaceutical company is currently looking for a Regulatory Affairs Manager with CTA, EU and experience to join their team on a 12 month temporary contract. Working with the regulatory team (and core stakeholders across multiple areas), your role will be to provide regulatory strategy and guidance across the region and make sure that...

  • Regulatory Affairs Manager

    6 days ago

    Uxbridge, United Kingdom Park Street People Full time £125 - £150

    Role OverviewAn innovative global pharmaceutical company is currently looking for a Regulatory Affairs Manager with CTA, EU and experience to join their team on a 12‑month temporary contract. The role works closely with the regulatory team and core stakeholders across multiple areas, providing regulatory strategy and guidance to ensure deadlines and...

  • Regulatory Affairs Manager

    2 weeks ago

    Uxbridge, United Kingdom Park Street People Full time

    An innovative global pharmaceutical company is currently looking for a Regulatory Affairs Manager with CTA, EU and early stage development experience to join their team on an initial 12-month contract. Working with the regulatory team (and core stakeholders across multiple areas), your role will be to provide regulatory strategy and guidance across the...

  • Senior Regulatory Affairs Manager EU Oncology

    2 weeks ago

    Uxbridge, United Kingdom Hays Full time

    Job DescriptionSenior Regional Regulatory Affairs Lead - Oncology (EU Markets)Your new companyAre you a seasoned regulatory affairs professional with a passion for oncology and a deep understanding of European regulatory frameworks? Our client, a leading global biopharmaceutical company, is seeking a Senior Regional Regulatory Affairs Lead to drive...

  • Senior Regulatory Affairs Manager EU Oncology

    2 weeks ago

    Uxbridge, United Kingdom Hays Full time

    Job DescriptionSenior Regional Regulatory Affairs Lead - Oncology (EU Markets)Want to make an application Make sure your CV is up to date, then read the following job specs carefully before applying.Your new companyAre you a seasoned regulatory affairs professional with a passion for oncology and a deep understanding of European regulatory frameworks? Our...

  • Regulatory Affairs Manager

    1 week ago

    Uxbridge, United Kingdom CK GROUP Full time

    CK Group are recruiting for a Regulatory Affairs Manager to join a biopharmaceutical company at their site based in Uxbridge or Cambridge on a on a contract basis for 12 months.**Salary**: Hourly: £45.56 PAYE or £60.35 Umbrella**Company**: Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by...

  • Regulatory Affairs Manager

    3 weeks ago

    Uxbridge, United Kingdom PE Global Full time

    PE Global are currently recruiting for a Regulatory Affairs Manager (CTA) with EU experience for an initial 12 month contract role with a leading multinational Pharma client based in either Uxbridge or Cambridge - 1 day per month in the office.You will be working with colleagues who are responsible for leading the European regulatory strategies and...

  • Regulatory Affairs Manager Cmc

    2 weeks ago

    Uxbridge, United Kingdom PE Global Full time

    **PE Global is currently recruiting for a Regulatory Affairs Manager for a leading multi-national Biotech client based in Uxbridge with a hybrid work option.** **Role**: - Responsible for the generation of country specific regulatory strategies and providing feedback to internal teams regarding submission plans and execution of the strategy for one or more...

  • Senior Regulatory Affairs Manager Hybrid

    2 weeks ago

    Uxbridge, United Kingdom PE Global Full time

    **PE Global is currently recruiting for a Senior Regulatory Affairs Manager for a leading multi-national Biotech client based in Uxbridge with the option to work from home.** **The purpose of this role is to ensure that the client acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as...