Regulatory Affairs Manager

2 weeks ago

Uxbridge, United Kingdom PE Global Full time

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.

  • Regulatory Affairs Manager

    3 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 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...

  • Regulatory Affairs Manager

    3 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 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...

  • Regulatory Affairs Manager

    3 weeks ago

    Uxbridge, United Kingdom CK Group- Science, Clinical and Technical Full time

    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...

  • Regulatory Affairs Manager

    3 weeks ago

    Uxbridge, United Kingdom CK Group- Science, Clinical and Technical Full time

    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....

  • Regulatory Affairs Manager

    3 weeks ago

    Uxbridge, United Kingdom CK Group Full time

    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....

  • Regulatory Affairs Manager

    2 weeks ago

    Uxbridge, United Kingdom PE Global Full time

    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.In order to make an application, simply read through the following job description and make sure to attach relevant documents.Responsibilities of the role: Advising the GRT on regional...

  • Regulatory Affairs Manager

    2 weeks ago

    Uxbridge, Greater London, 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 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...

  • CMC Regulatory Affairs Manager

    1 week ago

    Uxbridge, United Kingdom Park Street People Full time

    Our client, a global pharmaceutical company, is currently looking for a CMC Regulatory Affairs Manager to join their team in Uxbridge on a temporary contract. This is a great opportunity to work for a pharmaceutical company who have created a centre of excellence and constantly focus on driving innovation and using cutting edge techniques in their...

  • CMC Regulatory Affairs Manager

    1 week ago

    Uxbridge, United Kingdom Park Street People Full time

    Our client, a global pharmaceutical company, is currently looking for a CMC Regulatory Affairs Manager to join their team in Uxbridge on a temporary contract.This is a great opportunity to work for a pharmaceutical company who have created a centre of excellence and constantly focus on driving innovation and using cutting edge techniques in their science.Key...

  • Regulatory Affairs Manager

    2 weeks ago

    Uxbridge, United Kingdom PE Global Full time

    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.In order to make an application, simply read through the following job description and make sure to attach relevant documents.Responsibilities of the role: Advising the GRT on regional...

  • CMC Regulatory Affairs Manager

    5 days ago

    Uxbridge, United Kingdom Park Street People Full time

    Our client, a global pharmaceutical company, is currently looking for a CMC Regulatory Affairs Manager to join their team in Uxbridge on a temporary contract.This is a great opportunity to work for a pharmaceutical company who have created a centre of excellence and constantly focus on driving innovation and using cutting edge techniques in their science.Key...

  • CMC Regulatory Affairs Manager

    6 days ago

    Uxbridge, United Kingdom Park Street People Full time

    Our client, a global pharmaceutical company, is currently looking for a CMC Regulatory Affairs Manager to join their team in Uxbridge on a temporary contract.This is a great opportunity to work for a pharmaceutical company who have created a centre of excellence and constantly focus on driving innovation and using cutting edge techniques in their science.Key...

  • CMC Regulatory Affairs Manager

    5 days ago

    Uxbridge, United Kingdom Park Street People Full time

    Our client, a global pharmaceutical company, is currently looking for a CMC Regulatory Affairs Manager to join their team in Uxbridge on a temporary contract. This is a great opportunity to work for a pharmaceutical company who have created a centre of excellence and constantly focus on driving innovation and using cutting edge techniques in their science....

  • CMC Regulatory Affairs Manager

    6 days ago

    Uxbridge, United Kingdom Park Street People Full time

    Our client, a global pharmaceutical company, is currently looking for a CMC Regulatory Affairs Manager to join their team in Uxbridge on a temporary contract.This is a great opportunity to work for a pharmaceutical company who have created a centre of excellence and constantly focus on driving innovation and using cutting edge techniques in their science.Key...

  • CMC Regulatory Affairs Manager

    5 days ago

    Uxbridge, United Kingdom Park Street People Full time

    Job DescriptionOur client, a global pharmaceutical company, is currently looking for a CMC Regulatory Affairs Manager to join their team in Uxbridge on a temporary contract.This is a great opportunity to work for a pharmaceutical company who have created a centre of excellence and constantly focus on driving innovation and using cutting edge techniques in...

  • Regulatory Affairs Manager CMC

    1 week ago

    Uxbridge, United Kingdom CK Group- Science, Clinical and Technical Full time

    CK Group are recruiting for a Regulatory Affairs Manager CMC 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...

  • Regulatory Affairs Associate

    4 weeks ago

    Uxbridge, United Kingdom Proclinical Full time

    Proclinical are recruiting for a Regulatory Affairs Associate to join a pharmaceutical organisation. This role is on a contract basis and is either located in Uxbridge or Cambridge. **Key Skills and Requirements**: - Familiarity in an administrative field within a corporate or similar setting preferably within a healthcare sector. - Educated to a degree...

  • UK CW Regulatory Affairs Manager

    7 days ago

    Uxbridge, United Kingdom PE Global Full time

    PE Global is recruiting for a UK regulatory affairs manager for our leading pharmaceutical client in Uxbridge on an initial 12-month hybrid contract.Responsibilities: 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...

  • UK CW Regulatory Affairs Manager

    7 days ago

    Uxbridge, United Kingdom PE Global Full time

    PE Global is recruiting for a UK regulatory affairs manager for our leading pharmaceutical client in Uxbridge on an initial 12-month hybrid contract. Responsibilities: 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...

  • UK CW Regulatory Affairs Manager

    6 days ago

    Uxbridge, United Kingdom PE Global Full time

    PE Global is recruiting for a UK regulatory affairs manager for our leading pharmaceutical client in Uxbridge on an initial 12-month hybrid contract.Responsibilities: 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...