Regulatory Affairs Manager
- Experience Level
Role: Regulatory Affairs Manager
Location: Uxbridge or Dublin
Salary: Highly competitive + benefits
employment: full time, permanent
CPL Life Sciences are collaborating with a global biotechnology company that uses the power of science to bring new medicines to patients in need. Our client is looking for an experienced Regulatory Affairs professional to join their team in either Uxbridge or Dublin to focus on building their client’s regulatory profile in Europe and to take ownership of active clinical trial applications (CTAs), support for future new studies.
This is a development-focused role therefore, In order to be considered, our client requires experience in the following areas: CTA’s, PIP’S, ODD, MAA (hands-on), agency interaction experience, and CP (centralized procedure) experience, this is a must-have.
Other duties will include:
To further build our client’s regulatory profile in Europe and serve as a resource for European knowledge for the global regulatory and development teams.
Communicate with clinical teams in study start-up and maintenance activities by leading all associated regulatory activities, including but not limited to submissions, addressing agency queries, managing compliance issues.
Represent our clients in interactions with multiple CROs for a broad range of complex late-stage clinical studies.
Take advantage of the various regulatory systems and processes, in particular the application of innovative regulatory pathways to our development products.
Deliver leadership on both late and early-stage clinical development related process and strategy to ensure timely study conduct end to end.
Monitor emerging legislation and guidance and contribute to ensuring company-level awareness and compliance (where appropriate).
Provide support on all aspects related to the development of novel therapeutics such as pediatric investigational plan, scientific advice, and MAA related activities.
Education & Experience
Right to work in the UK
Ability to negotiate and concisely express clear positions to stakeholders and team members
Experience in directly working with national regulatory agencies
Degree in a scientific discipline, an advanced degree (Masters or Ph.D.) is preferred
5+ years regulatory industry experience with a focus on supporting products through clinical development
Proven track record of supporting European CTAs
Experience in dealings with the EMA (scientific advice, orphan designation, PIPs) with MAA applications or life-cycle management of approved products in the centralized procedure is preferred.
If you would like to apply for this position, please contact Amani via email@example.com . If you are not currently looking but know someone who would be good for this role then get in touch. We offer a referral scheme at CPL Life Sciences where in which a successful recommendation will earn you £250 worth of vouchers *terms and conditions apply*