Labcorp Drug Development is looking for a Director/Senior Director - Global Regulatory Affairs Strategy to join the team, candidates can be based anywhere in Europe.

The Director/Senior Director of Global Regulatory Affairs Strategy, Product Development Consulting will work closely with sponsor companies in developing regulatory strategies that will support drug development initiatives. This responsibility will include leading client interactions with regulatory agencies globally. This position will also work as an internal consultant/advisor across various LabCorp Drug Development business units to facilitate dialogue with our clients to develop relevant regulatory strategy and tactic plans to meet their drug development needs globally.

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Education/Qualifications:
Bachelors degree in a life science, pharmacy or medicine is required. PharmD, MD or PhD in a life science, pharmacy or medicine is preferred.
Experience:
8-10 years experience of drug development in the Pharma, biotech or CRO industry with at least 6-8 years experience in regulatory affairs developing global regulatory strategies for early and late stage development programs.

• Experience in discovery research, preclinical pharmacology, toxicology, or clinical research required.
• Proven history of finding novel solutions to challenging drug development issues and developing innovative regulatory strategies.
• Knowledge of regulatory guidance in multiple regions and industry best practices for drug development
• Experience with leading strategic planning, preparation and execution of Agency interactions.
• Experience leading teams through IND, CTA development, addressing agency questions to support the start up of clinical trials
• Experienced in leading teams through NDA/MAA development, submission and addressing Agency inquiries.
• Leadership role in HA negotiations in multiple regions/countries.
• The ability to develop effective multi-cultural relationships.
• Global people management/leadership experience required
• Excellent organizational skills and the ability to manage multiple important projects with tight timelines is essential.