Principal Consultant

Vor 7 Tagen


Munich, Deutschland Barrington James Limited Vollzeit

Clinical/RegulatoryConsultant
Location: Munich, Germany -Hybrid

About the Role

In thismatrix-structured role, you will provide strategic guidance andexpertise to development teams working on a variety of cutting-edgeprojects, including small molecules, biologicals, and ATMPs. Youwill be involved in all stages of development, from pre-clinicalresearch to regulatory submissions (MAA,NDA/BLA).

KeyResponsibilities:
  1. Offer strategicregulatory advice and support to projectteams.
  2. Oversee all clinical development aspectswithin project teams.
  3. Develop and execute acomprehensive global regulatory plan.
  4. Lead thedevelopment and implementation of the global agency interactionstrategy.
Qualifications:

Advanceddegree in life sciences, medicine, or veterinary medicine. Minimumof 10 years of experience in pharmaceutical development. Proventrack record in strategic clinical development and regulatoryaffairs (experience in people management is not sufficient).Experience working across different pharmaceutical companies and/orregulatory authorities (a plus). Excellent communication andinterpersonal skills, with the ability to explain complexdevelopment scenarios. Strategic thinking, solution-orientedapproach, and strong problem-solving skills. Ability to workindependently, manage multiple tasks under pressure, and prioritizeeffectively. Experience with EU and US regulatory procedures ispreferred.

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