- Provide the planning and leadership to the Regulatory Department by ensuring that appropriate structures, systems, and values are developed.
- Ensure that an appropriate infrastructure is in place to support the Marketing Authorisation responsibilities as defined in Directive 2001/82, Directive 2001/83 and as required for third country registrations.
- Represent the company for Competent Authority / Ministry of Health interactions including but not limited to attendance at Regulatory Authority meetings, Scientific Advice meetings, Quality Defect notifications, Recalls and Inspections.
- Ensure that the interfaces between Regulatory and other departments are managed optimally.
- Collaborate with marketing on product promotional plans and representative training activities and ensure regulatory compliance for promotional/non-promotional materials including websites and product information to HCPs and patients where required.
- Provide updates to the business on regulatory developments periodically.
- Identify and assess regulatory risks associated with the registrations and/or licences and define strategies to mitigate risks.
- As a member of the Senior Management team, work with other stakeholder (such as Commercial, Marketing and Finance) in developing strategy plans for new initiatives to ensure the timely entry of new products to the market and the ongoing success of existing products.
- Have responsibility for the financial management of the regulatory budget.
- Minimum Bachelor’s degree; studies in science or pharmacy desirable
- Minimum 8+ years working in the pharmaceutical/biotechnology industry with direct extensive experience in Regulatory Affairs.
- Desirable to have been trained in large pharma or biotech and subsequently also found success in a small company to leverage his/her learnings.
- Excellent knowledge of global, regional, national country requirements, regulatory affairs requirements for licensing and life cycle management.
- Demonstrated track record of success building relationships with, and influencing, regulatory agencies, particularly in situations requiring direct interaction/negotiation.
For further details and full job spec please contact Tina but email to firstname.lastname@example.org or call +353 1 2784701 or 087 6811990.
Thornshaw Scientific is a division of the CPL group. www.thornshaw.com