Director Global Regulatory Affairs
2 weeks ago
The Director, Global Regulatory Affairs will be responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives. The following information aims to provide potential candidates with a better understanding of the requirements for this role. DESCRIPTION OF THE ROLE
- Provide high level strategic and operational regulatory direction and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approvals in international markets, regulatory strategic development plans and risk assessments and lead Health Authority interactions
- Oversee, contribute to and/or prepare regulatory submissions.
- Perform and prepare due diligence assessments that may include risk mitigation strategies.
- Prepare regulatory teams for and lead meetings, including face-to-face, with Health Authorities
- Continually build upon and maintain knowledge base of global regulatory landscape, regulations, and guidance.
- Manage the development of the ongoing global regulatory strategy.
- Marketing access activities including pricing/contracts/product listings
- Postgraduate degree (MS/PhD/PharmD) in Pharmacy, Biological Sciences, or other related discipline
- 15+ years global regulatory affairs experience with increasing leadership in the pharmaceutical/biotechnology industry
- Solid knowledge of FDA, EMA and other global regulations and ICH guidelines
- Expert in product development and experience in early to late stage as well as post approval phases
- Demonstrated experience in leading face-to-face meetings with FDA, EMA and/or other Health Authorities
- Preparation of New Drug Applications and Marketing Authorisation Applications in eCTD format • Obtain Orphan Drug Designations in Europe and US
- High level of personal integrity and ethical behaviour • Strong leadership and staff development skills
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Director Global Regulatory Affairs
2 weeks ago
Surrey Quays, United Kingdom EPM Scientific Full timeThe Director, Global Regulatory Affairs will be responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives.The following information aims to provide potential candidates with a better understanding of the requirements for...
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Director Global Regulatory Affairs
1 month ago
Surrey, United Kingdom EPM Scientific Full timeThe Director, Global Regulatory Affairs will be responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives. DESCRIPTION OF THE ROLE • Provide high level strategic and operational regulatory direction and mentorship...
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Director Global Regulatory Affairs
1 month ago
Surrey, United Kingdom EPM Scientific Full timeThe Director, Global Regulatory Affairs will be responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives.DESCRIPTION OF THE ROLE• Provide high level strategic and operational regulatory direction and mentorship on...
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Director Global Regulatory Affairs
1 month ago
Surrey, United Kingdom EPM Scientific Full timeThe Director, Global Regulatory Affairs will be responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives. DESCRIPTION OF THE ROLE • Provide high level strategic and operational regulatory direction and mentorship...
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Director Global Regulatory Affairs
1 month ago
Surrey, United Kingdom EPM Scientific Full timeThe Director, Global Regulatory Affairs will be responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives.DESCRIPTION OF THE ROLE• Provide high level strategic and operational regulatory direction and mentorship on...
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Director Global Regulatory Affairs
3 weeks ago
Surrey, United Kingdom EPM Scientific Full timeJob DescriptionThe Director, Global Regulatory Affairs will be responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives.DESCRIPTION OF THE ROLE• Provide high level strategic and operational regulatory direction and...
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Director Global Regulatory Affairs
1 month ago
Surrey, United Kingdom EPM Scientific Full timeThe Director, Global Regulatory Affairs will be responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives. DESCRIPTION OF THE ROLE • Provide high level strategic and operational regulatory direction and mentorship on...
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Director of Policy and Regulatory Affairs
3 weeks ago
Uxbridge, Greater London, United Kingdom PE Global Full timePE Global is recruiting for a UK regulatory affairs manager for our leading pharmaceutical client in Uxbridge on an initial 12-month hybrid contract. 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 products. Ensuring...
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Director of Policy and Regulatory Affairs
4 weeks ago
Uxbridge, Greater London, United Kingdom PE Global Full timePE 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. 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. Act as a contact...
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Director of Policy and Regulatory Affairs
4 weeks ago
Uxbridge, Greater London, United Kingdom PE Global Full timePE 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. 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. Act as a contact...
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Senior Regulatory Affairs Manager
1 week ago
Surrey, United Kingdom RApport Global Strategic Services Ltd Full timeFind your place and use your experience to make an impact. We are RApport-ELIQUENT A specialist international regulatory consultancy, bringing cutting-edge and life-changing medicines and medical devices to global markets.The RApport-ELIQUENT team continues to grow from strength to strength, with the team applying our latest thinking in creating the next...
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Ghs/clp Chemical Regulatory Affairs Specialist
4 weeks ago
London, United Kingdom VRS Regulatory Full timeAn opportunity to join the Product Stewardship / Regulatory Compliance team at a global chemical business; you will ensure the compliance of globally sold, highly complex mixtures. Key duties will be SDS authoring, classifications, labelling, component compliance checks and providing regulatory advice to the technology, R&D, and customer service...
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Regulatory Specialist
4 days ago
London, United Kingdom VRS Regulatory Full timeJoin the regulatory affairs team at a global pest control products company.nFriendly and experienced teamnWork on compliance and registrations for a global portfolio of products.Duties will be varied and will include biocide product registrations / notifications, gathering data, compiling dossiers, liaison with testing teams, SDS authoring, classifications,...
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Regulatory Affairs Manager
3 weeks ago
Uxbridge, Greater London, United Kingdom PE Global Full timeJob Description 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...
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Regulatory Affairs Manager
13 hours ago
Uxbridge, Greater London, United Kingdom PE Global Full timeJob Description 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...
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UK CW Regulatory Affairs Manager
3 weeks ago
Uxbridge, Greater London, United Kingdom PE Global Full timePE 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...
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Global Regulatory Affairs Manager
4 weeks ago
London, United Kingdom WALKER COLE INTERNATIONAL LTD Full timeWalker Cole International are looking for a Senior Regulatory Affairs Associate to join an exciting clinical-stage Biopharmaceutical company in the UK. In this role you will be responsible for the development and execution of regulatory submissions for thebusiness' projects. You will be responsible for: - The maintenance of regulatory files and databases...
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Director of Policy and Regulatory Affairs
2 days ago
Weybridge, Surrey, United Kingdom Haleon Full timeManager Global Regulatory Affairs Labelling The purpose of this role is to provide regulatory leadership, governance and expertise to one sub-category or a brand or a portfolio of products such that the labelling of existing products is successfully maintained globally. In this role the individual will build a network of collaborative relationships...
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Senior Director Regulatory Affairs
4 days ago
London, United Kingdom Vector - Talent Solutions for the Pharmaceutical Supply Chain Full timeSenior Director of Regulatory Affairs – UK remoteAre you an expert within the European Regulatory Pharmaceutical Markets? Have you got experience leading successful approvals of MAA’s from the EMA?We are proud to partner with a global market leading biotech who have developed a state-of-the-art technology platform. They have technologies at clinical...
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Director Global Medical Affairs HIV
1 week ago
Uxbridge, Greater London, United Kingdom Gilead Sciences, Inc. Full timeDirector Global Medical Affairs HIV page is loaded Director Global Medical Affairs HIV Bewerben locations United Kingdom - Uxbridge time type Full time posted on Vor 5 Tagen ausgeschrieben job requisition id R0040757 For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Gilead, we’re...