Clinical Trial Submissions Manager

4 weeks ago

Maidenhead, United Kingdom Consult Remote Work Freelance Full time

Hybrid working 2x a week

Scope:

This is an excellent opportunity for an experienced Clinical Trial Submissions Manager to join a global pharmaceutical company for an initial 12 months with the potential for this to be extended. This role has come about due to expansion and an increase in the production of pharmaceutical. They are looking for someone with EU CTR/CTD/CTIS/CTA experience who is looking for a new opportunity to grow and develop their career.

Responsibilities:

  • Develop and execute CTA regulatory strategies and operations for a designated portfolio of developmental compounds across specified regions: WE, EEMEA, LA, and select JAPAC countries, ensuring alignment with global regulatory strategies and regional requirements
  • Design and implement regulatory strategies and deliverables for global clinical trial applications in accordance with the overarching global regulatory strategy considering regional specific requirements
  • Coordinate submission strategies for global clinical trials, ensuring alignment with regulatory strategies, and promptly highlighting any risks or issues to GRPT and study teams
  • Ensure timely achievement of study deliverables in accordance with global regulatory strategies and evolving global clinical trial legislation, including compliance with the EU Clinical Trial Regulation and company protocols
  • Serve as the primary liaison between the company and regulatory authorities for streamlined assessment procedures
  • Act as main interface between global subject matter expert functions and affiliates to implement clinical development regulatory strategies and achieve desired outcomes
  • Populate and manage regulatory databases to oversee data collation, and track regulatory submissions

About You:

  • Possesses a minimum of 6 years' experience in the pharmaceutical industry, with a focus of at least 5 years in Regulatory Affairs, including extensive involvement in global clinical trials.
  • Demonstrates experience in overseeing multinational programs of Clinical Trial Applications (CTAs).
  • Exhibits a comprehensive understanding of global clinical trial legislation, including but not limited to the EU Clinical Trials Directive, Voluntary Harmonization Procedure, Clinical Trial Regulation, as well as familiarity with evolving regulatory environments, Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), ICH guidelines, and other relevant protocols related to clinical trial supply management.
  • Preference for knowledge and experience in medical device legislation relevant to clinical trials.
  • Holds a degree in medicine, pharmacy, biology, chemistry, pharmacology, or a related life sciences discipline.

  • Regulatory Manager, Clinical Trial Strategy

    1 month ago

    Maidenhead, United Kingdom SRG Full time

    SRG are currently looking for a Regulatory Affairs Manager for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory Affairs team on an initial 12 Month basis to be based at their office in Maidenhead. The Role: Deliver CTA regulatory strategies and operations for a designated portfolio of development compounds in specified...

  • Regulatory Manager, Clinical Trial Strategy

    1 week ago

    Maidenhead, United Kingdom SRG Full time

    SRG are currently looking for a Regulatory Affairs Manager for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory Affairs team on an initial 12 Month basis to be based at their office in Maidenhead. The Role: Deliver CTA regulatory strategies and operations for a designated portfolio of development compounds in specified...

  • Regulatory Manager, Clinical Trial Strategy

    2 weeks ago

    Maidenhead, United Kingdom SRG Full time

    SRG are currently looking for a Regulatory Affairs Manager for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory Affairs team on an initial 12 Month basis to be based at their office in Maidenhead.The Role:Deliver CTA regulatory strategies and operations for a designated portfolio of development compounds in specified...

  • Regulatory Manager, Clinical Trial Strategy

    1 month ago

    Maidenhead, United Kingdom SRG Full time

    SRG are currently looking for a Regulatory Affairs Manager for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory Affairs team on an initial 12 Month basis to be based at their office in Maidenhead.The Role:Deliver CTA regulatory strategies and operations for a designated portfolio of development compounds in specified...

  • Regulatory Manager, Clinical Trial Strategy

    4 weeks ago

    Maidenhead, United Kingdom SRG Remote Work Freelance Full time

    SRG are currently looking for a Regulatory Affairs Manager for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory Affairs team on an initial 12 Month basis to be based at their office in Maidenhead.The Role: Deliver CTA regulatory strategies and operations for a designated portfolio of development compounds in specified...

  • Manager, Clinical Trial Strategy

    1 month ago

    Maidenhead, United Kingdom SRG Full time

    Job DescriptionSRG are currently looking for a Regulatory Affairs Manager for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory Affairs team on an initial 12 Month basis to be based at their office in Maidenhead or remotely.The Role:Deliver CTA regulatory strategies and operations for a designated portfolio of development...

  • Manager, Clinical Trial Strategy

    1 month ago

    Maidenhead, United Kingdom SRG Full time

    SRG are currently looking for a Regulatory Affairs Manager for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory Affairs team on an initial 12 Month basis to be based at their office in Maidenhead or remotely.The Role:Deliver CTA regulatory strategies and operations for a designated portfolio of development compounds in...

  • Manager, Clinical Trial Strategy

    2 months ago

    Maidenhead, United Kingdom SRG Full time

    SRG are currently looking for a Regulatory Affairs Manager for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory Affairs team on an initial 12 Month basis to be based at their office in Maidenhead or remotely.The Role:Deliver CTA regulatory strategies and operations for a designated portfolio of development compounds in...

  • Manager, Clinical Trial Strategy

    4 weeks ago

    Maidenhead, United Kingdom SRG Full time

    SRG are currently looking for a Regulatory Affairs Manager for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory Affairs team on an initial 12 Month basis to be based at their office in Maidenhead or remotely.Qualifications, skills, and all relevant experience needed for this role can be found in the full description...

  • Manager, Clinical Trial Strategy

    1 month ago

    Maidenhead, United Kingdom SRG Full time

    SRG are currently looking for a Regulatory Affairs Manager for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory Affairs team on an initial 12 Month basis to be based at their office in Maidenhead or remotely. The Role: Deliver CTA regulatory strategies and operations for a designated portfolio of development compounds...

  • Manager, Clinical Trial Strategy

    1 month ago

    Maidenhead, United Kingdom SRG Full time

    SRG are currently looking for a Regulatory Affairs Manager for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory Affairs team on an initial 12 Month basis to be based at their office in Maidenhead or remotely.The Role:Deliver CTA regulatory strategies and operations for a designated portfolio of development compounds in...

  • Clinical Trial Manager

    3 weeks ago

    Maidenhead, United Kingdom Consult Full time

    CTS ManagernMaidenheadnVery competitive salarynHybrid working 2x a weeknInitial 12 month contract which is likely to be extendedThis is an excellent opportunity for an experienced CTS Manager to join a global pharmaceutical company for an initial 12 months with the potential for this to be extended. This role has come about due to expansion and an increase...

  • Clinical Trial Manager

    1 week ago

    Maidenhead, United Kingdom Consult Full time

    CTS ManagernMaidenheadnVery competitive salarynHybrid working 2x a weeknInitial 12 month contract which is likely to be extendedThis is an excellent opportunity for an experienced CTS Manager to join a global pharmaceutical company for an initial 12 months with the potential for this to be extended. This role has come about due to expansion and an increase...

  • Regulatory Manager, Clinical Trial Strategy

    1 month ago

    Maidenhead, Berkshire, United Kingdom SRG Full time

    SRG are currently looking for a Regulatory Affairs Manager for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory Affairs team on an initial 12 Month basis to be based at their office in Maidenhead. The Role: Deliver CTA regulatory strategies and operations for a designated portfolio of development compounds in specified...

  • Regulatory Manager, Clinical Trial Strategy

    2 weeks ago

    Maidenhead, Berkshire, United Kingdom SRG Full time

    SRG are currently looking for a Regulatory Affairs Manager for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory Affairs team on an initial 12 Month basis to be based at their office in Maidenhead. The Role: Deliver CTA regulatory strategies and operations for a designated portfolio of development compounds in specified...

  • Regulatory Manager, Clinical Trial Strategy

    1 week ago

    Maidenhead, Berkshire, United Kingdom SRG Full time

    SRG are currently looking for a Regulatory Affairs Manager for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory Affairs team on an initial 12 Month basis to be based at their office in Maidenhead. The Role: Deliver CTA regulatory strategies and operations for a designated portfolio of development compounds in specified...

  • Regulatory Manager, Clinical Trial Strategy

    3 weeks ago

    Maidenhead, Berkshire, United Kingdom SRG Full time

    SRG are currently looking for a Regulatory Affairs Manager for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory Affairs team on an initial 12 Month basis to be based at their office in Maidenhead. The Role: Deliver CTA regulatory strategies and operations for a designated portfolio of development compounds in specified...

  • Clinical Trial Manager

    2 weeks ago

    Maidenhead, United Kingdom Consult Full time

    CTS ManagerBefore applying for this role, please read the following information about this opportunity found below.MaidenheadVery competitive salaryHybrid working 2x a weekInitial 12 month contract which is likely to be extendedThis is an excellent opportunity for an experienced CTS Manager to join a global pharmaceutical company for an initial 12 months...

  • Clinical Trial Manager

    1 week ago

    Maidenhead, United Kingdom Consult Full time

    CTS ManagerMaidenheadVery competitive salary Hybrid working 2x a week Initial 12 month contract which is likely to be extended This is an excellent opportunity for an experienced CTS Manager to join a global pharmaceutical company for an initial 12 months with the potential for this to be extended. This role has come about due to expansion and an increase in...

  • Clinical Trial Manager

    3 weeks ago

    Maidenhead, United Kingdom Consult Full time

    CTS Manager Maidenhead Very competitive salary Hybrid working 2x a week Initial 12 month contract which is likely to be extended This is an excellent opportunity for an experienced CTS Manager to join a global pharmaceutical company for an initial 12 months with the potential for this to be extended. This role has come about due to expansion and...