Clinical Regulatory Affairs

BioTalent; Bayern; Hybrid; EUR 80.000 - 120.000; Vollzeit

Zusammenfassung

A leading global life science consultancy firm is seeking a Clinical Regulatory Consultant to provide regulatory expertise across various projects from Pre-Clinical to Phase 3. This hybrid position requires at least 3 days on-site in Southern Germany but remote work may be considered for the right candidate. Ideal candidates will possess a Ph.D. and 10+ years of experience in pharmaceutical development.

Qualifikationen

• At least 10 years of experience in pharmaceutical development.
• Practical experience in strategic clinical development and regulatory strategy.

Aufgaben

• Provide strategic regulatory guidance to project teams.
• Cover clinical development in the project teams.
• Plan and execute the global regulatory development plan.
• Responsible for the global agency interaction strategy.

Kenntnisse

Clinical Development

Regulatory Strategy

Strategic Planning

Global Agency Interaction

Ausbildung

Ph.D. in Biology, Biomedicine, Biochemistry or Medical Degree

Jobbeschreibung

Job Title: Clinical Regulatory Consultant - Global Life Science Consultancy Firm

Location: Germany

Company Overview:

Our client are a leading consultancy company who have over 1000 global clients across biotech and pharmaceuticals. They are currently expanding the team as they now have a vast number of various projects coming in across various therapeutic areas and modalities.

Position Overview:

We are seeking a dedicated and talented individual with expertise in Clinical Development and Regulatory Strategy and will act as the expert for various clients. You will have the opportunity to work across various projects from Pre-Clinical to Phase 3.

• Providing strategic regulatory guidance to project teams
• Covering clinical development in the project teams
• Planning and executing the global regulatory development plan
• Responsible for the global agency interaction strategy

Qualifications:

• Ph.D, in Biology, Biomedicine, Biochemistry or a Medical Degree or DVM.
• At least 10 years of experience in pharmaceutical development
• Practical experience in strategic clinical development (not clinical operations) and regulatory strategy
• Ideally experience across different pharmaceutical companies and/or regulatory authorities
• This is a hybrid role in Southern Germany and would require at least 3 days per week on site, however for the right individual remote working could be considered.