Director Global Regulatory Affairs
3 weeks ago
ABOUT THE ROLE
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.
DESCRIPTION OF THE ROLE
Based in Surrey, the Director, Global Regulatory Affairs is expected to:
• 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
ESSENTIAL REQUIREMENTS FOR ROLE
• 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
• Strong attention to detail and time management
• Strong written and communication skills
WHAT’S ON OFFER:
• A competitive salary with benefits.
• The chance to contribute and be part of team whose work directly benefits healthcare and strives to improve people’s lives.
• A real hands-on opportunity to gain a high degree of commercial exposure.
• The chance to work alongside world-leading scientific experts.
• Working with highly-talented and dedicated colleagues in a fast-growing company that combines a focus on cutting-edge science with commercial delivery
-
Director Global Regulatory Affairs
5 days ago
Surrey, United Kingdom EPM Scientific Full timeABOUT THE ROLE Making sure you fit the guidelines as an applicant for this role is essential, please read the below carefully.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...
-
Director Global Regulatory Affairs
3 weeks ago
Surrey, United Kingdom EPM Scientific Full timeABOUT THE ROLE 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. DESCRIPTION OF THE ROLE Based in Surrey, the Director, Global Regulatory Affairs is expected to:...
-
Director Global Regulatory Affairs
3 weeks ago
Surrey, United Kingdom EPM Scientific Full timeABOUT THE ROLE 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. DESCRIPTION OF THE ROLE Based in Surrey, the Director, Global Regulatory Affairs is expected...
-
Director Global Regulatory Affairs
2 weeks ago
Surrey, United Kingdom EPM Scientific Full timeABOUT THE ROLE 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. DESCRIPTION OF THE ROLE Based in Surrey, the Director, Global Regulatory Affairs is expected to: •...
-
Director Global Regulatory Affairs
3 weeks ago
Surrey, United Kingdom EPM Scientific Full timeABOUT THE ROLE 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. DESCRIPTION OF THE ROLE Based in Surrey, the Director, Global Regulatory Affairs is expected to:...
-
Director Global Regulatory Affairs
4 days ago
Surrey, United Kingdom EPM Scientific Full timeABOUT THE ROLE 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 information below covers the role requirements, expected candidate experience, and accompanying...
-
Director Global Regulatory Affairs
7 days ago
Surrey Quays, United Kingdom EPM Scientific Full timeABOUT THE ROLE Making sure you fit the guidelines as an applicant for this role is essential, please read the below carefully.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...
-
Director Global Regulatory Affairs
2 days ago
Surrey Quays, United Kingdom EPM Scientific Full timeABOUT THE ROLE 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 information below covers the role requirements, expected candidate experience, and accompanying...
-
Director Global Regulatory Affairs
2 weeks ago
Surrey, UK, South East England, United Kingdom EPM Scientific Full timeABOUT THE ROLE 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. DESCRIPTION OF THE ROLE Based in Surrey, the Director, Global Regulatory Affairs is expected to: •...
-
Director of Global Regulatory Affairs
2 days ago
Surrey, United Kingdom EPM Scientific Full timeAbout the RoleThe Director of 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.Key ResponsibilitiesProvide high-level strategic and operational regulatory direction and...
-
Director of Global Regulatory Affairs
2 days ago
Surrey, United Kingdom EPM Scientific Full timeAbout the RoleThe Director of 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.Key ResponsibilitiesProvide high-level strategic and operational regulatory direction and...
-
Director of Global Regulatory Affairs
5 days ago
surrey, United Kingdom EPM Scientific Full timeAbout the RoleJob SummaryThe Director of 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.Key ResponsibilitiesProvide high-level strategic and operational regulatory direction...
-
Global Regulatory Affairs Director
4 days ago
Surrey Quays, Greater London, United Kingdom EPM Scientific Full timeAbout the RoleThe 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.This role is based in Surrey and is expected to:Provide high-level strategic and operational...
-
Global Regulatory Affairs Director
4 days ago
Surrey Quays, Greater London, United Kingdom EPM Scientific Full timeAbout the RoleThe 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.This role is based in Surrey and is expected to:Provide high-level strategic and operational...
-
Regulatory Affairs Director
2 days ago
Surrey, United Kingdom EPM Scientific Full timeJob Summary: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.Key Responsibilities:Provide high-level strategic and operational regulatory direction and mentorship on...
-
Regulatory Affairs Director
5 days ago
Surrey, United Kingdom EPM Scientific Full timeJob Summary: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.Key Responsibilities:Provide high-level strategic and operational regulatory direction and mentorship on...
-
Head of Global Regulatory Affairs
6 days ago
Surrey, United Kingdom EPM Scientific Full timeAbout the RoleThe Director of Global Regulatory Strategy 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.Key Responsibilities:Provide high-level strategic and operational regulatory direction and...
-
Director of Regulatory Compliance
3 weeks ago
Surrey, United Kingdom EPM Scientific Full timeABOUT THE ROLE 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. Based in Surrey, the Director, Global Regulatory Affairs is expected to: • Provide high level...
-
Director of Regulatory Compliance
3 weeks ago
Surrey, United Kingdom EPM Scientific Full timeABOUT THE ROLE 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. Based in Surrey, the Director, Global Regulatory Affairs is expected to: • Provide high level...
-
Director of Global Regulatory Strategy
6 days ago
Surrey, United Kingdom EPM Scientific Full timeAbout the RoleThe Director of Global Regulatory Strategy 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.Key Responsibilities:Provide high-level strategic and operational regulatory direction and...