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Director Global Regulatory Affairs

2 months ago

Surrey UK, South East England, United Kingdom EPM Scientific Full time

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