Associate Director Regulatory Affairs
- Ireland, Dublin
- Contract
- Compliance / Quality Assurance
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.
Essential duties and responsibilities for this role include, but are not limited to, the following:
- 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.
- 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
#LI-TE1
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
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Tom
I manage this role.