Overview
Associate Director Regulatory Affairs - Ireland, Dublin - 12 Month Contract
Are you looking for the chance to join a life changing pharmaceutical organisation in their mission to continuously drive innovation? We are recruiting for a Associate Director Regulatory Affairs to support the Dublin function.
Responsibilities
* Developing and implementing global regulatory strategies for assigned products.
* Providing regulatory strategic oversight for projects in the relevant therapeutic areas/portfolio, as assigned, aligned to overall Enterprise objectives through initial registration and subsequent lifecycle management.
* Providing input to submission strategy and other critical regulatory documents. May act as the point of contact with relevant Health Authorities and/or lead interactions with such authorities or other relevant external stakeholders.
* May provide input to internal governance and advisory bodies from which GRA staff can seek insight on strategic and procedural/operational issues as they arise.
* Actively being up to date on latest regulatory requirements and trends and contribute to the shaping of the regulatory science environment.
* Support regulatory intelligence and policy priorities based on internal knowledge and expertise.
* Ensuring exemplary behavior, leadership, ethics and transparency within the Enterprise, with Health Authorities and other external stakeholders.
Desirable experience/Qualifications
* Extensive Regulatory experience in the pharmaceutical industry, with significant track record on Global Strategies.
* Strong knowledge of drug development and regulatory policy, coupled by excellent scientific and business judgement.
* Experience providing strategic regulatory advice for the global development of products through all stages of development including marketed assets.
* Successful track record in registering and overseeing regulatory strategies for assets.
* Bachelor’s Degree, life science highly desirable
* Postgraduate degrees relevant to the role (e.g. MSc, PhD) a plus
If this role is of interest, please apply now.
#LI-TE1
#J-18808-Ljbffr