Director Global Regulatory Affairs
2 weeks ago
Director Global Regulatory Affairs
BOUT 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.
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 skill
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Director Global Regulatory Affairs
2 weeks ago
United Kingdom EPM Scientific Full timeDirector Global Regulatory AffairsBOUT 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.Global Regulatory Affairs is expected to:• Provide high level...
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Director Global Regulatory Affairs
2 weeks ago
United Kingdom EPM Scientific Full timeDirector Global Regulatory Affairs BOUT 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. Global Regulatory Affairs is expected to: • Provide high...
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Director Global Regulatory Affairs
2 weeks ago
United Kingdom EPM Scientific Full timeDirector Global Regulatory Affairs BOUT 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. Global Regulatory Affairs is expected to: • Provide high...
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Director Global Regulatory Affairs
2 weeks ago
United Kingdom EPM Scientific Full timeDirector Global Regulatory AffairsBOUT 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.Global Regulatory Affairs is expected to:• Provide high level...
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United Kingdom Gilead Sciences, Inc. Full timeDirector, Global Regulatory Affairs, Precision Medicine Director, Global Regulatory Affairs, Precision Medicine United Kingdom - Cambridge Regulatory Regular Job Description At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working...
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