Director Global Regulatory Affairs

Full Job Description

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

• 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