Global Head of Regulatory Affairs - Pharma sector
North American Global Pharmaceutical company is establishing a new corporate headquarters in Dublin and are seeking a Global Head of Regulatory Affairs to be based here in Dublin. This role will involve working closely with the US regulatory agencies and managing all regulatory matters internally throughout the entire project lifecycle of projects. Attractive opportunity to join a globally recognised senior exec team at the start of a very exciting journey…
Roles / Responsibilities:
- Developing and rolling out the Global Regulatory Strategy for this organisation.
- Assuming full responsibility for ensuring all projects are fully aligned and delivered in line with this global strategy which will involve leading and mentoring project teams.
- Taking responsibility for ensuring all projects are delivered on time and to agreed specifications and deliverables.
- Keeping up to date with the ever changing global regulatory environment and managing all risks associated with any changes which may delay projects and ensuring full compliance with US and other global regulatory bodies.
- Managing key external relationships with regulatory authorities, agencies and bodies.
- Internal stakeholder management across the organisation to ensure the regulatory strategy is understood and integral to all operations across the organisation.
- Regular interaction with senior executive team and shareholders.
- Develop in house training and educational material for staff around regulatory matters.
Education / Requirements:
- Must be degree qualified (science) with at least 10 years experience in the pharmaceutical / health care industry.
- Prior experience working in a Global Regulatory Affairs role with strong knowledge of the drug development process and European & North American regulatory environment.
- Proven Project Management skills and experience of running large cross functional
- First rate stakeholder management skills – both internal and external.
- Role will require regular travel to North America.
If you would like to discuss this exciting opportunity further, please apply by sending your CV to firstname.lastname@example.org or call Robin Craig on +353 1 8746770 for a confidential conversation.