Head of Regulatory Affairs

3 weeks ago

Glasgow, United Kingdom Mentholatum UK Ltd Full time

 

Job title: Head of Regulatory Affairs

Position reports to: Director of QA and RA

Direct reports:

RA Manager (UK, EEA, EAEU, CIS)

RA Manager (Middle East)

Compliance Manager

Location:  East Kilbride/hybrid

Employment status:  Full time, permanent

Travel requirements:  Occasional domestic/international travel may be required.

Other special requirements:  Some knowledge of a second language preferable - Arabic

Overall purpose of the job

To oversee the Regulatory Affairs (RA) activities for all Mentholatum products in all territories to support the manufacture, importation, sale and supply of medicines, medical devices, cosmetics, and other product categories.

To formulate strategy and actions to assure successful initiation, management and maintenance of regulatory authorisations, through liaison with Competent Authorities, and contractors.

To provide a “one stop shop” for the Mentholatum business to use for regulatory advice and support, as well as coordination of training for key areas of the business in regulatory requirements.

To assure and maintain the compliance of the business with regulatory requirements.

To develop, maintain and assure interaction of the RA team with suitable systems to support progression and compliance.

Principal duties, deliverables and accountabilities

Principal duties:

To effectively manage the RA team resources: To assure that the RA team has the necessary training and support required to fulfil their roles.

To delegate tasks commensurate with their individual skill levels;  including evaluation of workload, quality and metrics through regular review and reporting of findings.

To assure appropriate RA actions are taken within required timescales in support of the introduction of new products and registrations to help develop and grow the Mentholatum  business.

To assure that all product registrations and certifications, including facility registrations, are maintained and compliant across the Mentholatum territories.

To effectively collaborate with all functional categories within the business:

To provide clear and consistent regulatory advice and information on registrations and activities To collaborate with functions on change management and compliance

To collaborate with NPD to develop innovative claims and formulations that will optimise routes to market. To provide sound regulatory strategy and advice to support Senior Management within the business.

Core responsibilities / deliverables:

Formulate RA strategy and complete regulatory activities to agreed schedules.

Oversee and/or contribute to regulatory submissions prepared by the regulatory team.

Mentor and encourage sharing of knowledge with the regulatory team to help build, establish, and maintain a strong regulatory presence.

Establish and maintain regulatory intelligence to best support the business

Key accountabilities:

Ensure principal duties are carried out accurately, professionally, in compliance and to schedule. Continually build upon and maintain knowledge base of global regulatory landscape, regulations, and guidance

Ensure monthly report is delivered in a timely manner. 

Skills, knowledge, experience and qualifications required

Skills

Excellent written, oral and presenting skills

Ability to lead and work in a team with a strong sense of responsibility.

Ability to work effectively with senior management, remaining motivated and enthusiastic in times of change and other pressure situations.

Capability to professionally represent the department and the company both externally and internally. Knowledge

Extensive experience in pharmaceutical regulatory affairs and medical device legislation.

Experience of the regulatory environment in the territories covered by Mentholatum.

Experience of working in or with manufacturing, quality assurance, (pharmacovigilance), marketing and commercial. Experience of interfacing with Competent Authorities globally.

Experience

Broad experience and knowledge in the field of RA for medicines, medical devices and preferably also cosmetics.

Experience in defining and implementing RA Quality Management Processes.

Experience in interpreting and explaining regulatory concepts

Experience with proactively communicating and interacting directly with Competent Authorities. Senior executive level or greater in RA

Qualifications

Bachelor's Degree in Life Science or related discipline, advanced degree advantageous but not essential. Desirable MSc Regulatory Affairs or Medical Technology

Member of TOPRA

At least 10 years regulatory experience

 

  • Head of Regulatory Affairs

    13 hours ago

    Glasgow, United Kingdom Mentholatum UK Ltd Full time

    Job title: Head of Regulatory Affairs Position reports to: Director of QA and RA Direct reports: RA Manager (UK, EEA, EAEU, CIS) RA Manager (Middle East) Compliance Manager Location : East Kilbride/hybrid Employment status : Full time, permanent Travel requirements : Occasional domestic/international travel may be required. Other...

  • Head of Regulatory Affairs

    7 days ago

    Glasgow, United Kingdom Mentholatum UK Ltd Full time

    Job title: Head of Regulatory Affairs Position reports to: Director of QA and RA Direct reports: RA Manager (UK, EEA, EAEU, CIS) RA Manager (Middle East) Compliance Manager Location : East Kilbride/hybrid Employment status : Full time, permanent Travel requirements : Occasional domestic/international travel may be required. Other special...

  • Head of Regulatory Affairs

    2 weeks ago

    Glasgow, United Kingdom Mentholatum UK Ltd Full time

    Job title: Head of Regulatory Affairs Position reports to: Director of QA and RA Direct reports: RA Manager (UK, EEA, EAEU, CIS) RA Manager (Middle East) Compliance Manager Location : East Kilbride/hybrid Employment status : Full time, permanent Travel requirements : Occasional domestic/international travel may be required. Other special...

  • Head of Regulatory Affairs

    10 hours ago

    Glasgow, Glasgow City, United Kingdom Mentholatum UK Ltd Full time

    Job title: Head of Regulatory AffairsPosition reports to: Director of QA and RADirect reports:RA Manager (UK, EEA, EAEU, CIS)RA Manager (Middle East)Compliance ManagerLocation: East Kilbride/hybridEmployment status: Full time, permanentTravel requirements: Occasional domestic/international travel may be required.Other special requirements: Some knowledge of...

  • Regulatory Affairs

    1 day ago

    Glasgow, United Kingdom Mentholatum UK Ltd Full time

    Job title: Head of Regulatory Affairs Position reports to: Director of QA and RA Direct reports: RA Manager (UK, EEA, EAEU, CIS) RA Manager (Middle East) Compliance Manager Location : East Kilbride/hybrid Employment status : Full time, permanent Travel requirements : Occasional domestic/international travel may be required. Other special...

  • Regulatory Affairs

    2 weeks ago

    Glasgow, United Kingdom Mentholatum UK Ltd Full time

    Job title: Head of Regulatory Affairs Position reports to: Director of QA and RA Direct reports: RA Manager (UK, EEA, EAEU, CIS) RA Manager (Middle East) Compliance Manager Location : East Kilbride/hybrid Employment status : Full time, permanent Travel requirements : Occasional domestic/international travel may be required. Other special...

  • Principal- Regulatory Affairs

    1 month ago

    Glasgow, United Kingdom FPSG Full time

    **Regulatory Affairs Principal** **Overview** FPSG Life Sciences is delighted to be supporting our key client to recruit a Principal in their Regulatory Affairs team in Glasgow. Experience in medical devices or in Vitro diagnostics would be advantageous. Fantastic opportunity to be a part of a global business undergoing significant...

  • Regulatory Affairs

    13 hours ago

    Glasgow, United Kingdom Mentholatum UK Ltd Full time

    Job title: Head of Regulatory Affairs Position reports to: Director of QA and RA Direct reports: RA Manager (UK, EEA, EAEU, CIS) RA Manager (Middle East) Compliance Manager Location : East Kilbride/hybrid Employment status : Full time, permanent Travel requirements : Occasional domestic/international travel may be required. Other special...

  • Head of Legal, Compliance

    17 hours ago

    Glasgow, United Kingdom Edrington Full time

    **Requisition Id**:1760**Location**:Glasgow, Scotland, GB, G1 3DNAbout Edrington Edrington’s vision is to give more by crafting exceptional ultra-premium spirit brands. The Macallan is our central focus, supported by Highland Park and The Glenrothes in the fast-growing single malt category and Naked Malt in the blended malt category. Our portfolio is...

  • Public Affairs Advisor

    1 month ago

    Glasgow, United Kingdom Statkraft Full time

    Public Affairs Advisor - Full-time **Company Description**: Statkraft is Europe's largest generator of renewable energy from hydro, wind and solar power. We have over 5,300 employees in 21 countries. We have been making clean energy possible for over 125 years, with unrivalled expertise in supplying the world with what it needs most. We envision a world...

  • Public Affairs Advisor

    4 weeks ago

    Glasgow, United Kingdom Statkraft Full time

    Company Description Statkraft is Europe's largest generator of renewable energy from hydro, wind and solar power. We have over 5,300 employees in 21 countries. We have been making clean energy possible for over 125 years, with unrivalled expertise in supplying the world with what it needs most. We envision a world that runs entirely on renewable...

  • Head of Student Conduct

    1 month ago

    Glasgow, United Kingdom University of Glasgow Full time

    **Job Purpose** To be responsible for the management, development and delivery of the University’s Codes relating to student conduct in support of the University’s vision and strategies, and to provide professional leadership to the Student Conduct Team. Serve as the University-wide lead for the implementation of systems and operations for student...

  • Head of Government Relations

    1 month ago

    Glasgow, United Kingdom University of Glasgow Full time

    **Job Purpose** The Head of Government Relations will lead and manage the University’s public affairs activity, including identifying key public policy priorities, advising the Principal on and managing relationships, taking forward high-level meetings with political stakeholders and implementing appropriate actions with key external stakeholders and...

  • Head of Professional Services

    1 month ago

    Glasgow, United Kingdom University of Glasgow Full time

    **Job Purpose** As an integral member of both the School's Leadership Team and the College Administrative Management Group, the post holder will play a lead role in the successful implementation and delivery of the College and School's strategy, policies, and objectives, in order to fully achieve key University/College/School goals and deliver improvements...

  • Head of Professional Services

    4 weeks ago

    Glasgow, United Kingdom University of Glasgow Full time

    **Job Purpose** As an integral member of both the School's Leadership Team and the College Administrative Management Group, the post holder will play a lead role in the successful implementation and delivery of the College and School's strategy, policies, and objectives, in order to fully achieve key University/College/School goals and deliver improvements...

  • Head of Data and Applications

    1 month ago

    Glasgow, United Kingdom University of Glasgow Full time

    **Job Purpose** As a key member of both the RCB Executive Team and the RCB Operational Management Group, the Head of Data and Applications is a senior strategic leadership post and will lead on the planning and implementation of innovative, efficient and effective data management systems and robust data governance strategy, and make a significant...

  • Head of School, School of Humanities/ceannard Sgoil

    1 month ago

    Glasgow, United Kingdom University of Glasgow Full time

    Head of School, School of Humanities/Ceannard Sgoil nan Daonnachdan **University of Glasgow** **School of Humanities/Sgoil nan Daonnachdan** **Head of School/Ceannard Sgoil nan Daonnachdan** **Role Description** The Head of School reports to the VP/Head of College and performs a pivotal and instrumental academic leadership role in the University's...

  • Head of Corporate Governance

    2 days ago

    Glasgow, Glasgow City, United Kingdom Glasgow School of Art Full time

    Applications are invited for the Head of Corporate Governance within the Corporate Governance department at The Glasgow School of Art. The purpose of the role of the Head of Corporate Governance is:To provide high quality professional support to the Secretary and Registrar in ensuring the effective and efficient governance of the Glasgow School of Art.To...

  • Senior Project Manager

    2 weeks ago

    Glasgow, United Kingdom Head Resourcing Ltd Full time

    Senior Project Manager - Payments & Fraud Inside IR35£500 - £589 to umbrella Remotely based in the UK Our client, a large financial services organisation is looking for a Senior Project Manager to join their growing team within Fraud and Financial Crime to work on a Payments Systems regulatory project. Deemed Inside IR35 this role will require to be...

  • Head of Department

    1 month ago

    Glasgow, Glasgow City, United Kingdom University of Strathclyde Full time

    As a leading international University, we pride ourselves in recruiting the best academic and professional staff to support our ground-breaking, impactful research, and our first-class student experience.The Department of Civil and Environmental Engineering is a dynamic, multidisciplinary environment known for its friendly and supportive research and...