Dublin, Republic of Ireland
about 2 months ago
Job title: Global Regulatory Affairs Director, Paediatrics
A well-known pharmaceutical company are seeking a Global Regulatory Affairs Director to work in their recently launched paediatric centre of excellent office in Dublin. This is an exciting opportunity to join HIV and Emerging Viruses Regulatory Affairs where you will provide global regulatory strategic and technical leadership of regulatory activities for pediatric product development.
- Responsible for providing strategic regulatory guidance on the development of global pediatric submissions, including those required in the US and EU.
- Responsible for leading all pediatric-related regulatory activities for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
- Responsible for ensuring responsibilities of Applicant and/or License Holder defined in legislation or regulatory guidance for pediatric products is met for assigned product(s) and territories.
- Maintains knowledge of highly complex regulatory requirements up to date, contribute to preparation of new pediatric regulatory guidance wherever possible, comments on draft regulatory guidance and communicates changes in regulatory information to project teams and senior management.
- Prepare and/or manage others' submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs.
- Significant level of experience in Regulatory Affairs or other relevant industry experience with advanced degree
- Must have extensive knowledge of pediatric regulatory requirements, including ICH requirements and regional requirements for assigned territories and an understanding of current global and regional trends in Regulatory Affairs and ability to assess the impact of these requirements to the business.
- Degree in a scientific field is preferred
- Pediatric drug development experience is required
- Is recognized as an expert resource for Regulatory Advice in other departments.
Salary and benefits:
A highly competitive annual salary, car allowance, bonus, initial stock reward, annual stock reward, private medical and pension are on offer. A generous relocation package is also available - offering temporary accommodation, home sale assistance and rent contribution.
To apply for this position or hear further details then please contact Matt Thomas via email@example.com