Regulatory Affairs Specialist Job in Dublin
Our client's Corporate Regulatory Affairs team are responsible for global regulatory activities from early development throughout the life-cycle of products in over 80 countries globally.
The Position
The position will be responsible for ensuring regulatory maintenance, marketing and compliance of all products which will necessitate extensive knowledge of US and EU regulatory requirements. The position will also require the ability to apply regulatory knowledge both strategically and operationally to development projects and marketed products. Demonstration of a comprehensive knowledge of medicinal product manufacturing, drug laws, regulations and guidelines is also essential as the position will represent Regulatory Affairs in cross-functional groups and forums in support of these activities.
In addition, the position will liaise with affiliates worldwide to support regulatory activities specific to maintenance of national licenses.
Minimum Qualifications
* Relevant scientific degree, M.Sc. Pharm. or equivalent
* Minimum 5-7 years of experience in Regulatory Affairs with strong emphasis on European and US experience in New Drug Applications and life cycle management of quality documentation
* API /Drug Substance regulatory experience post licensure
* Experience in electronic document management
* Excellent communication (verbal/written), organisational and interpersonal skills
* Effective project management skills with the ability to influence and collaborate among team members
* Strong and proactive team player who thrives on working in an international environment
* Proficient understanding of the lifecycle management of products.