Current jobs related to Regulatory Affairs Specialist - Maidenhead, Windsor and Maidenhead - Select Pharma Limited

  • Regulatory Affairs Specialist

    2 weeks ago

    Maidenhead, Windsor and Maidenhead, United Kingdom Fortrea Full time

    Fortrea, a leading global contract research organization, is seeking a skilled Regulatory Affairs Specialist to support the preparation and submission of key documentation to regulatory authorities for new clinical trials. The ideal candidate will have a strong understanding of regulatory guidelines and legislation related to drug and biologic products.Key...

  • Regulatory Affairs Specialist

    2 weeks ago

    Maidenhead, Windsor and Maidenhead, United Kingdom Pharmiweb Full time

    Job Title: Regulatory Affairs SpecialistJob Summary:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Pharmiweb. As a Regulatory Affairs Specialist, you will be responsible for preparing and submitting key documentation to regulatory authorities for new clinical trials of investigational medicinal products in the UK and...

  • Regulatory Affairs Specialist

    3 weeks ago

    Maidenhead, Windsor and Maidenhead, United Kingdom Biogen Full time

    About This RoleWe are seeking a highly motivated and proactive graduate to join our Regulatory Affairs team as a Regulatory Affairs Specialist. In this role, you will be responsible for coordinating and enabling implementation of artwork changes for EU marketed products, ensuring compliance with regulatory requirements.Key ResponsibilitiesLead change...

  • Regulatory Affairs Manager OTC

    4 weeks ago

    Maidenhead, Windsor and Maidenhead, United Kingdom Hays Specialist Recruitment Limited Full time

    Regulatory Affairs Manager OTC Job DescriptionThis well-established Consumer Health company is seeking an experienced Regulatory Affairs Manager / Senior Manager to join their team. The role is a 6-month contract with potential for extension.Main Responsibilities:Manage post-approval activities for specified OTC products.Support the EMEA Regulatory Affairs...

  • Regulatory Affairs Manager OTC

    4 weeks ago

    Maidenhead, Windsor and Maidenhead, United Kingdom Hays Specialist Recruitment Limited Full time

    Regulatory Affairs Manager OTC Job DescriptionThis well-established Consumer Health company is seeking an experienced Regulatory Affairs Manager / Senior Manager to join their team. The role is a 6-month contract with potential for extension.Main Responsibilities:Manage post-approval activities for specified OTC products.Support the EMEA Regulatory Affairs...

  • Regulatory Affairs Manager OTC

    4 weeks ago

    Maidenhead, Windsor and Maidenhead, United Kingdom Hays Specialist Recruitment Limited Full time

    Regulatory Affairs Manager / Senior Manager OTC Job DescriptionOur client, a well-established Consumer Health company, is seeking an experienced Regulatory Affairs Manager / Senior Manager to join their team on a 6-month contract basis with potential for extension.Main Responsibilities:Manage post-approval activities for specified OTC productsSupport the...

  • Regulatory Affairs Manager OTC

    4 weeks ago

    Maidenhead, Windsor and Maidenhead, United Kingdom Hays Specialist Recruitment Limited Full time

    Regulatory Affairs Manager / Senior Manager OTC Job DescriptionOur client, a well-established Consumer Health company, is seeking an experienced Regulatory Affairs Manager / Senior Manager to join their team on a 6-month contract basis with potential for extension.Main Responsibilities:Manage post-approval activities for specified OTC productsSupport the...

  • Regulatory Affairs Director OTC

    3 weeks ago

    Maidenhead, Windsor and Maidenhead, United Kingdom Hays Specialist Recruitment Limited Full time

    Job Title: Regulatory Affairs Senior Manager OTCOur client, a well-established Consumer Health company, is seeking an experienced Regulatory Affairs Senior Manager to join their team on a 6-month contract basis, with potential for extension.About the Role:The successful candidate will be responsible for managing post-approval activities for specified OTC...

  • Regulatory Affairs Director OTC

    3 weeks ago

    Maidenhead, Windsor and Maidenhead, United Kingdom Hays Specialist Recruitment Limited Full time

    Job Title: Regulatory Affairs Senior Manager OTCOur client, a well-established Consumer Health company, is seeking an experienced Regulatory Affairs Senior Manager to join their team on a 6-month contract basis, with potential for extension.About the Role:The successful candidate will be responsible for managing post-approval activities for specified OTC...

  • Regulatory Affairs Specialist

    3 weeks ago

    Maidenhead, Windsor and Maidenhead, United Kingdom Fortrea Full time

    Regulatory Specialist Opportunity at FortreaFortrea, a leading global contract research organization, is seeking a proactive Regulatory Specialist to join our client-dedicated team. As a key member of our team, you will support Clinical Operation Managers and a team of Start-Up Specialists in the preparation and submission of key documentation to regulatory...

  • Regulatory Affairs Specialist

    3 weeks ago

    Maidenhead, Windsor and Maidenhead, United Kingdom Fortrea Full time

    Regulatory Specialist Opportunity at FortreaFortrea, a leading global contract research organization, is seeking a proactive Regulatory Specialist to join our client-dedicated team. As a key member of our team, you will support Clinical Operation Managers and a team of Start-Up Specialists in the preparation and submission of key documentation to regulatory...

  • Regulatory Affairs Specialist

    2 weeks ago

    Maidenhead, Windsor and Maidenhead, United Kingdom Pharmiweb Full time

    Job Title: Regulatory Affairs SpecialistAbout the Role:Fortrea is seeking a skilled Regulatory Affairs Specialist to join our team. As a leading global contract research organization (CRO), we provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more...

  • Regulatory Affairs Specialist

    2 weeks ago

    Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full time

    Regulatory Affairs OpportunityAn exciting opportunity has become available with Select Pharma Limited, a growing pharmaceutical company, for an experienced and enthusiastic Regulatory Affairs professional wishing to expand their experience and knowledge in a growing Reg team.Key Responsibilities:Conversion of existing applications to eCTD format.Preparation...

  • Regulatory Affairs Specialist

    2 weeks ago

    Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full time

    An exciting opportunity has become available with Select Pharma Limited, a growing pharmaceutical company, for an experienced and enthusiastic Regulatory Affairs professional wishing to expand their experience and knowledge in a growing Reg team. With a focus on post-approval activities, the successful candidate will gain exposure to many aspects of...

  • Regulatory Affairs Specialist

    4 weeks ago

    Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full time

    Regulatory Affairs ProfessionalAn exciting opportunity has become available with Select Pharma Limited, a growing pharmaceutical company, for an experienced and enthusiastic Regulatory Affairs professional wishing to expand their experience and knowledge in a growing Reg team.About the Role:Converting existing applications to eCTD format and ensuring...

  • Regulatory Affairs Specialist

    4 weeks ago

    Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full time

    Regulatory Affairs ProfessionalAn exciting opportunity has become available with Select Pharma Limited, a growing pharmaceutical company, for an experienced and enthusiastic Regulatory Affairs professional wishing to expand their experience and knowledge in a growing Reg team.About the Role:Converting existing applications to eCTD format and ensuring...

  • Regulatory Affairs Specialist

    4 weeks ago

    Maidenhead, Windsor and Maidenhead, United Kingdom Fortrea Full time

    Regulatory Start-Up SpecialistFortrea is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20...

  • Regulatory Affairs Specialist

    4 weeks ago

    Maidenhead, Windsor and Maidenhead, United Kingdom Fortrea Full time

    Regulatory Start-Up SpecialistFortrea is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20...

  • Regulatory Affairs Specialist

    4 weeks ago

    Maidenhead, Windsor and Maidenhead, United Kingdom Pharmiweb Full time

    Job Title: Regulatory Start-Up SpecialistFortrea is seeking a highly skilled Regulatory Start-Up Specialist to join our team. As a leading global contract research organization (CRO), we provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20...

  • Regulatory Affairs Specialist

    4 weeks ago

    Maidenhead, Windsor and Maidenhead, United Kingdom Pharmiweb Full time

    Job Title: Regulatory Start-Up SpecialistFortrea is seeking a highly skilled Regulatory Start-Up Specialist to join our team. As a leading global contract research organization (CRO), we provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20...

Regulatory Affairs Specialist

2 months ago

Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full time
Job Description

**Regulatory Affairs Officer**

We are seeking an experienced and enthusiastic Regulatory Affairs professional to join our growing team at Select Pharma Limited. This exciting opportunity will provide the successful candidate with exposure to various aspects of Regulatory compliance and the chance to supervise and guide a team.

Key Responsibilities:

  • Convert existing applications to eCTD format.
  • Prepare and submit Sunset clause, MA cancellation applications, MA transfers, remediation dossiers as required by the Company.
  • Ensure completion of post-approval commitments, if any.
  • Compile and maintain Product license files.
  • Coordinate regulatory activities with QPPV and QP (Quality/GMP) for management of MAs.
  • Process and communicate regulatory approvals internally and to external stakeholders.
  • Participate in the review of process/product changes, deviations, product complaints, adverse drug reactions, medical information, and batch recall to determine the need for any regulatory activities and to ensure compliance to regulatory requirements.
  • Maintain regulatory files/database and chronologies in good order. Maintain system for tracking changes in documents submitted to agencies or partners.
  • Publishing activities including converting/binding of pdf files, resolve validation issues.
  • Compile and submit variations.
  • Work in accordance with Company's working Instructions and SOPs.
  • Carry out other activities which contribute to the effective performance of the Regulatory Affairs Department.

Requirements:

  • Pharmacy/Chemistry degree.
  • 1-2 years Regulatory Affairs experience.
  • Understanding of the current UK and European regulations, laws, guidelines, and industry requirements.
  • Exposure to NeeS/eCTD format and electronic submission gateways is preferable.
  • Experience with Generic products and MRP/DCP submissions is advantageous.