Associate Director Regulatory Affairs
3 weeks ago
Job title: Associate Director, Regulatory Affairs
A Pharmaceutical business in London is looking for an Associate Director, Regulatory Affairs to join their Global team. In this role you will provide strategic regulatory and scientific assessment on preclinical requirements, and clinical development plans to bring new products to patients in the most efficient way.
Responsibilities:
- Working together with multi-functional / geographical teams and other internal stakeholders to ensure that projects meet all key objectives and are delivered on time.
- Develop Regulatory Strategies for any new submissions as well as identifying risks.
- Contribute to the preparation of briefing packages for Scientific Advice, orphan drug designation, PRIME program.
- Participate during the interactions with Health Authorities.
Requirements:
- Substantial experience within Regulatory affairs and pharmaceutical industry.
- Extensive experience in the submission of new products.
- Experience working with new MA's.
- Experience interacting with EU/UK regulatory authorities.
Salary and benefits:
A highly competitive salary and wider benefits scheme is on offer.
To apply for this position or hear further details then please contact Freddie Hill via
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