As part of our international Regulatory Affairs team, you report directly to Senior Management and support global product registrations and regulatory strategy. You collaborate with scientists, clinicians and AI specialists to implement AIRA (AI-Augmented Regulatory Affairs) — our framework for accelerating regulatory submissions using digital twins and artificial intelligence.
Your responsibilities
- Prepare regulatory submissions for FDA, EMA, Swissmedic and other authorities
- Coordinate international product registrations
- Maintain regulatory documentation
- Monitor changing regulatory requirements
- Support AI-enabled regulatory workflows
- Participate in scientific meetings with regulatory authorities
- Work closely with Quality Assurance and Clinical Development
- Coordinate international product registrations
- Maintain regulatory documentation
- Monitor changing regulatory requirements
- Support AI-enabled regulatory workflows
- Participate in scientific meetings with regulatory authorities
- Work closely with Quality Assurance and Clinical Development
Your profile
- Degree in Pharmacy, Life Sciences or a related field
- Experience with international pharmaceutical regulations
- Knowledge of FDA, EMA and ICH guidelines
- Excellent documentation skills
- Fluent English
- Experience with international pharmaceutical regulations
- Knowledge of FDA, EMA and ICH guidelines
- Excellent documentation skills
- Fluent English