Director of Regulatory Affairs – EU
This leading pharmaceutical company is a fully integrated business focused on the development, approval, and commercialisation of speciality pharmaceutical products, including a line of generic dermatology products where this organisation is an established leader, and speciality injectable oncology products. Employing north of 1000 staff globally with operations in the U.S and EU, this organisation produces a portfolio of over 25 products with growing pipeline at late stage clinical trials. Due to expansion here in Europe, a new requirement for a Director of EU Reg Affairs has arisen to be based at their EU HQ here in Dublin.
- Direct strategy for Regulatory Affairs to meet established company goals.
- Define and manage external advisor/consultants required to meet company goals.
- Act as advisor to peers and subordinates to meet schedules/goals and resolve technical and procedural problems.
- Develop and implement budgets, timelines and performance requirements.
- Develop regulatory strategies for domestic and international registrations and determine best regulatory path/action for device and drug products, both in development and post-approval.
- Manage development and post-approval registration.Represent company as liaison with regulatory agencies.
- Function as senior regulatory advisor on project teams when needed.
- Ensure regulatory documentation meets set standards and adheres to established regulatory strategy.
- Monitor progress of regulatory projects and responsibilities.
- Direct labeling function.
- Evaluate workload and resources relative to company and department goals.
- Procure appropriate consultants and contract research organisation(s) to address registration and labelling needs.
- In partnership with other regulatory staff, maintains and develops knowledge of regional regulatory requirements (e.g. new regulations and laws) that affect the further clinical development and commercialisation of company products.
- Performs all other duties as required.
- BSc in a Science or related discipline
- Strong working knowledge of the EU medicinal product regulations and guidance and the ability to understand and interpret EU and international governmental regulations/guidelines and apply them so that regulatory requirements are met.
- Demonstrated record of success in gaining regulatory approval in the EU.
To learn more apply on line or call Shane Browne on +353 1 6321865.
Salary: On Application
Location: Dublin City Centre