Senior Regulatory Affairs Clinical Specialist (Biotechnology, Onsite)

Job summary

This role involves providing regulatory guidance and direction across clinical development programs, focusing on global submissions and health authority interactions. The position requires strategic thinking combined with hands-on execution to support the development of innovative peptide-based medicines.

Qualifications

• Master's degree in Life Science, Health Science, or a related field
• Several years of regulatory experience in a similar capacity, preferably within the pharmaceutical industry or a Health Authority
• Proven experience with clinical trial applications and regulatory submissions

Responsibilities

• Offer regulatory expertise and guidance for global development projects
• Serve as the regulatory lead in clinical trial teams throughout planning, execution, and reporting phases
• Contribute to the preparation of EU MAA and US NDA documentation and submissions
• Support interactions with health authorities and develop Q&A strategies
• Collaborate with regulatory, clinical, non-clinical, and writing teams
• Monitor new legislation, guidelines, and industry trends in clinical development
• Drive process improvement initiatives within Regulatory Affairs and across the organization

Skills

• Strong regulatory judgment and structured approach to complex requirements
• Excellent communication skills and a collaborative mindset
• Strong IT/digital skills, particularly with Veeva Vault

Tools

• Veeva Vault