Biotech / Clinical Research Director / Regulatory Affairs Specialist
Company: Hydrogen Nexus Hub
- Location: Germany
- Seniority: Director
- Employment type: Part-time
- Posted: 14 days ago
- Offer language: English
Job description
Role Description
These roles support biotechnology research, clinical development, and regulatory activities that advance products from investigation towards approval. They work with scientific, clinical, quality, and business teams to maintain reliable evidence, coordinate development activities, and prepare accurate documentation.
Biotech positions focus on laboratory research and product development. Clinical Research Director positions oversee study strategy, teams, budgets, and delivery. Regulatory Affairs Specialist positions prepare submissions, assess requirements, and support communication with regulatory authorities.
Qualifications
- Bachelor’s degree in Biotechnology, Life Sciences, Pharmacy, Medicine, or a related field.
- Relevant experience in biotechnology research, clinical development, or regulatory affairs.
- For biotech positions, practical knowledge of laboratory methods, experimental design, and scientific data analysis.
- For director positions, substantial experience leading clinical studies, multidisciplinary teams, and external research partners.
- Understanding of clinical protocols, research ethics, data integrity, and quality practices.
- Ability to assess scientific evidence and prepare clear technical documentation.
- For regulatory positions, experience compiling submission packages and responding to documentation queries.
- Experience managing project timelines, identifying risks, and coordinating corrective actions.
- Strong communication, organisational, and stakeholder-management skills.
- An advanced degree is advantageous and may be required for research leadership positions.
