Associate Director, Global Regulatory Affairs

3 days ago


Hatfield, United Kingdom Gi Group Full time

Permanent role
Remote working
Excellent Benefits
Competitive Salary
- Representing regulatory strategy as the Global Regulatory
Lead on International Project Teams and to lead the global Regulatory Sub-team
- Representing regulatory strategy as the EU regulatory Lead on assigned projects.
- Providing regulatory strategy and submission support to help drive the full drug development
process.
- Networking and interact effectively with key regulatory agencies.
- Focusing on driving forward the clinical development process for key compounds assigned,
by ensuring the timely submission of all clinical trial for New Active Substances
contributing to clinical development plans and providing advice on regulatory clinical trial
requirements to the International Project Teams
- Leading major submissions and negotiate with Health Authorities for the approval of
products with optimal labelling.
- Maximising product life cycle management and licence maintenance for clients current
marketed products.
- Providing direction and advice to members of the Regulatory Affairs department as
appropriate.
What is the client looking for?
A qualification in a Life Sciences, Chemistry, Toxicology, Pharmacology or other relevant discipline (or equivalent) and a demonstrated background in a Regulatory Affairs function gained within a specialist care therapy area within the Pharmaceutical industry.
Specific experience in Oncology would be highly advantageous, but is not essential.
Your experience will include some or all of the following:

- A good knowledge of the global regulatory environment.
- Ability to direct Regulatory Strategy and contribute to its outcome within area of
responsibility.
- Strong EU regulatory experience and a good understanding of US regulatory processes.
- Experience of both early and late phase drug development process and working with
international project teams.
- Experience of providing strategic input into regulatory documentation and integrated global
development plans.
- Good experience of working with regulatory agencies, including leading agency scientific
advice and pre-submission meetings/discussions and writing agency briefing documents.
- Extensive submission experience ( scientific advice requests,
- Experience in managing a team preferable but not essential.
The client offers a competitive salary and excellent wider benefits package.



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