Job Description
This is a rare opportunity to join one of the most exciting young global biopharmaceutical companies, headquartered here in Dublin. With a rich development and commercial pipeline our client is focussed on rare and orphan diseases.
The newly created position of Regulatory Affairs Manager, EU EMEA will report to the Head of Regulatory Affairs, and will be responsible for the implementation of European regulatory activities and associated oversight of interactions with associated health regulatory authorities. This position is also responsible for oversight and resource planning for Europe (EU and non-EU), Middle East, and Africa.
Job Spec :
- Execute the preparation, submission, and approval of major filings in the region
- Support meetings with the European Medicines Agency
- Collaborate with EU and global colleagues to ensure unified execution of EMEA regulatory strategy for products primarily for treatment of rare diseases
- Responsible for preparation and submission of high-quality regulatory dossiers according to agreed timelines utilising cross-functional interactions, excellent project management and writing skills and good understanding of the underlying science
- Work with Regulatory Operations to ensure appropriate planning, preparation and submission of regulatory documentation
- Oversee contracted resources throughout the covered region in accordance with objectives and needs
- Provide input to EMEA regulatory budget planning
- Participate in multidisciplinary study teams and in global regulatory strategy teams to provide regulatory guidance and communicate EU regulatory requirements
- Collaborate with regulatory-CMC and manufacturing colleagues to ensure seamless integration of CMC components to relevant submissions
- Collaborate with and advise EMEA commercial and medical colleagues regarding integration of regulatory and access strategies
- Contribute to developing and implementing patient-focused regulatory strategy
- Drive adherence to EU regulations and guidelines
- Maintain knowledge of EU competitive landscape, EU regulatory policy environment and participate in EU regulatory intelligence activities
- Develop and direct the activities of EMEA regulatory affairs personnel/external contractors
Person Spec:
- Advanced degree in a scientific discipline
- 5 years + prior experience in product development and post marketing Regulatory Affairs in the biopharmaceutical industry, preferably in rare diseases
- Experience in dealings with the EMA (scientific advice, orphan designation, PIPs) is an advantage
- Well-versed in regulatory strategy, ICH and EMA guidelines
- Ability to negotiate and concisely express clear positions to stakeholders at all levels
- Excellent written and verbal communication skills
- Comfortable speaking to and presenting scientific and clinical data