Regulatory Compliance Manager

3 weeks ago

London Area, United Kingdom B&S Group Full time

PRIMARY RESPONSIBILITIES


  • Manage the preparation and review of dossiers for MA variation applications, MA renewals and other regulatory post licensing submission in all territories in which Syri/ Syri Pharma holds marketing authorisations and ensures timely submission of applications meeting pre agreed timelines
  • Manage the preparation and review of responses to requests for further information from regulatory authorities for all post approval regulatory submissions.
  • Liaise and follow up with regulatory authorities submissions and regulatory issues.
  • Maintaining the product life cycle once the licence is approved.
  • Responsible for the preparation, maintenance and review of product approval packages.
  • Ensure with internal and external contacts that regulatory dossiers maintained, up to date and in compliance following the current best practice standards.
  • Prepare with SOPs, Change controls and review of internal processes. Creating and monitoring all regulatory changes through change control system.
  • Manage staff assigned to post approval regulatory affairs in the UK.
  • Co-ordinate post approval regulatory activity with regulatory team In India
  • Manage and ensure regulatory compliance ensuring manufacturing, testing and release activities and labelling are in compliance with approved registrations at Syri and CMO manufacturing sites. Liaising with CMO sites when required and provide regulatory support to facilitate batch release.


ESSENTIAL

  • Well-developed regulatory compliance experience in the pharmaceutical industry. At least 6 years of relevant experience in the pharmaceutical industry, with preferably 4 years in compliance in Regulatory Affairs preferably with some Quality Assurance experience
  • Well developed understanding of the medicines manufacturing testing and release
  • Good knowledge of EU directives, ICH guidelines.UK requirements
  • Ability to prepare high quality regulatory submissions
  • Ability to communicate effectively with regulatory authorities and other departments.
  • Ability to handle multiple tasks in a fast-paced and constantly changing environment
  • Good presentation and training skills
  • Good analytical and investigation skills.
  • Project management skills; excellent planning and organizational skills.


OTHER

  • Educated at Bachelor's Degree, Master's Degree or even a Ph.D.
  • Regulatory audits and inspections experience is an asset

  • Compliance Manager

    11 hours ago

    London, Greater London, United Kingdom Compliance Professionals Full time

    About the Role:Compliance Professionals is seeking a highly skilled Compliance Manager to join our team. As a Compliance Manager, you will play a critical role in ensuring that our organization operates in compliance with all relevant laws, regulations, and industry standards.Key Responsibilities:Develop and implement effective compliance policies and...

  • Compliance Manager

    9 hours ago

    London, Greater London, United Kingdom Compliance Professionals Full time

    About the Role:Compliance Professionals is seeking a highly skilled Compliance Manager to join our team. As a Compliance Manager, you will play a critical role in ensuring that our organization operates in compliance with all relevant laws, regulations, and industry standards.Key Responsibilities:Develop and implement effective compliance policies and...

  • Ad Regulatory Compliance

    3 months ago

    London, United Kingdom Compliance Professionals Full time

    **THE COMPANY**: Our client is a global institutional investment management firm, based in the City. They are looking for a Regulatory Compliance specialist to join the team. The role is hybrid with 2/3 days expected in the office each week. **THE RESPONSIBILITIES**: - Assist in the management, supervised by the Director, Risk & Compliance, of the risk and...

  • Compliance Manager

    5 days ago

    London, Greater London, United Kingdom Compliance Professionals Full time

    Company OverviewCompliance Professionals is a leading fintech banking group that operates globally. We are seeking a highly skilled Compliance Manager to join our London-based team.Job SummaryWe are looking for a seasoned Compliance Manager to lead our regulatory efforts and provide strategic guidance to our senior management team. The ideal candidate will...

  • Compliance Manager

    5 days ago

    London, Greater London, United Kingdom Compliance Professionals Full time

    Company OverviewCompliance Professionals is a leading fintech banking group that operates globally. We are seeking a highly skilled Compliance Manager to join our London-based team.Job SummaryWe are looking for a seasoned Compliance Manager to lead our regulatory efforts and provide strategic guidance to our senior management team. The ideal candidate will...

  • Regulatory Compliance Specialist

    4 weeks ago

    London, Greater London, United Kingdom Compliance Professionals Full time

    ABOUT THE ORGANIZATION:Our client is a forward-thinking investment platform operating within the Fintech sector, poised for significant expansion. They are in search of a Regulatory Compliance Specialist to enhance their team.KEY RESPONSIBILITIES:Oversee daily financial promotion approvals, address complaints, conduct transaction assessments, and manage...

  • Compliance Manager

    3 days ago

    London, Greater London, United Kingdom Compliance Professionals Full time

    Job DescriptionThe CompanyOur global fintech banking group is a leading financial institution that provides innovative banking solutions to individuals and businesses worldwide.The RoleWe are seeking a highly skilled Compliance Manager to join our London-based team. As a key member of our compliance department, you will be responsible for leading regulatory...

  • Compliance Manager

    3 days ago

    London, Greater London, United Kingdom Compliance Professionals Full time

    Job DescriptionThe CompanyOur global fintech banking group is a leading financial institution that provides innovative banking solutions to individuals and businesses worldwide.The RoleWe are seeking a highly skilled Compliance Manager to join our London-based team. As a key member of our compliance department, you will be responsible for leading regulatory...

  • Regulatory Compliance Consultant

    4 weeks ago

    London, Greater London, United Kingdom Compliance Professionals Full time

    COMPANY OVERVIEW:Our client is a comprehensive investment brokerage firm with a global footprint and a robust culture of compliance, making it a desirable workplace.KEY RESPONSIBILITIES:Conduct reviews, audits, and investigations as requested by Exchanges and Regulatory authorities.Provide advisory services for FATCA and CRS compliance, along with various...

  • Regulatory Compliance Consultant

    4 weeks ago

    London, Greater London, United Kingdom Compliance Professionals Full time

    COMPANY OVERVIEW:Our client is a comprehensive investment brokerage firm with a global footprint and a robust culture of compliance, making it a desirable workplace.KEY RESPONSIBILITIES:Conduct audits and investigations in response to requests from Exchanges and Regulatory authorities.Provide advisory services for FATCA and CRS compliance, along with various...

  • Regulatory Compliance Consultant

    4 weeks ago

    London, Greater London, United Kingdom Compliance Professionals Full time

    COMPANY OVERVIEW:Our client is a comprehensive investment brokerage firm with a global footprint and a robust culture of compliance, making it a desirable workplace.KEY RESPONSIBILITIES:Conduct reviews, audits, and investigations in response to requests from Exchanges and Regulatory authorities.Provide advisory services for FATCA and CRS compliance; engage...

  • Regulatory Compliance Specialist

    4 weeks ago

    London, Greater London, United Kingdom Compliance Professionals Full time

    Position OverviewABOUT THE ORGANIZATION:Compliance Professionals is a dedicated firm specializing in compliance solutions for investment management, overseeing assets totaling over £18 billion.KEY RESPONSIBILITIES:Continuously assess and improve the Compliance Monitoring Framework, collaborating with management and department heads on compliance...

  • Regulatory Compliance Specialist

    4 weeks ago

    London, Greater London, United Kingdom Compliance Professionals Full time

    Position OverviewABOUT THE ORGANIZATION: Compliance Professionals is a dedicated firm specializing in investment management, overseeing assets totaling over £18 billion.KEY RESPONSIBILITIES:Continuously assess and improve the Compliance Monitoring Framework, collaborating with management and department heads on compliance controls.Conduct daily compliance...

  • Regulatory Compliance Specialist

    4 weeks ago

    London, Greater London, United Kingdom Compliance Professionals Full time

    ABOUT THE ORGANIZATION:Our client is a prominent investment-focused fund management entity, overseeing assets totaling over £18 billion. KEY RESPONSIBILITIES:Continuous assessment and improvement of the Compliance Monitoring Framework, including controls and oversight, collaborating with management and department heads on compliance measures.Daily...

  • Regulatory Compliance Specialist

    4 weeks ago

    London, Greater London, United Kingdom Compliance Professionals Full time

    COMPANY OVERVIEW:Our organization is a dedicated, investment-focused fund management firm, overseeing assets totaling over £18 billion. KEY RESPONSIBILITIES:Continuous assessment and improvement of the Compliance Monitoring Framework, including controls and oversight, collaborating with management and department heads on compliance measures.Daily compliance...

  • Compliance Director

    3 days ago

    London, Greater London, United Kingdom Compliance Professionals Full time

    Job DescriptionCompliance Professionals is seeking a highly skilled Compliance Director to join our team in London. As a key member of our compliance team, you will play a critical role in ensuring our organization's compliance with regulatory requirements.Key Responsibilities:Regulatory Horizon Scanning: Lead the identification and analysis of emerging...

  • Compliance Director

    3 days ago

    London, Greater London, United Kingdom Compliance Professionals Full time

    Job DescriptionCompliance Professionals is seeking a highly skilled Compliance Director to join our team in London. As a key member of our compliance team, you will play a critical role in ensuring our organization's compliance with regulatory requirements.Key Responsibilities:Regulatory Horizon Scanning: Lead the identification and analysis of emerging...

  • Compliance Director

    7 hours ago

    London, Greater London, United Kingdom Compliance Professionals Full time

    Job Description:Job Title: Compliance Director - Regulatory ExpertCompany: Compliance ProfessionalsJob Type: Full-timeLocation: LondonJob Category: ComplianceJob Description:We are seeking a highly skilled Compliance Director to join our team at Compliance Professionals. As a Compliance Director, you will be responsible for ensuring that our organization's...

  • Compliance Director

    8 hours ago

    London, Greater London, United Kingdom Compliance Professionals Full time

    Job Description:Job Title: Compliance Director - Regulatory ExpertCompany: Compliance ProfessionalsJob Type: Full-timeLocation: LondonJob Category: ComplianceJob Description:We are seeking a highly skilled Compliance Director to join our team at Compliance Professionals. As a Compliance Director, you will be responsible for ensuring that our organization's...

  • Head of Regulatory Compliance

    3 days ago

    London, Greater London, United Kingdom AJ FOX COMPLIANCE Full time

    Job DescriptionWe're seeking a seasoned Legal Risk & Compliance professional with a passion for Anti-Money Laundering (AML), regulatory compliance, and conflict management to join AJ FOX COMPLIANCE as our Head of Regulatory Compliance.This high-impact role covers all aspects of AML, sanctions, and regulatory compliance while driving innovation and best...