Senior Regulatory Affairs Engineer
Company: HOUSE OF ABY
- Location: Basel, Switzerland
- Seniority: Senior
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
As part of our continued growth in Switzerland, we are looking for a Senior Regulatory Affairs & Licensing Specialist to support strategic projects with leading pharmaceutical, biotech, and MedTech companies across the Basel region and French-speaking Switzerland.
This position offers the opportunity to work in highly regulated international environments, contributing to product development, market authorizations, lifecycle management, and global regulatory compliance activities.
Your Mission
As a Senior Regulatory Affairs & Licensing Specialist, you will play a key role in ensuring regulatory compliance and supporting registration and licensing activities throughout the product lifecycle.
Working closely with Quality, R&D, Manufacturing, Clinical, Supply Chain, and Business teams, you will provide regulatory expertise to support product development, market access, and commercialization strategies.
Key Responsibilities
Regulatory Affairs & Compliance
- Ensure compliance with applicable regulatory requirements throughout the product lifecycle.
- Prepare, review, and maintain regulatory files and technical documentation.
- Contribute to change control, deviation assessment, and lifecycle management activities.
Licensing & Market Authorizations
- Support the preparation, submission, maintenance, and renewal of Marketing Authorization Applications (MAA).
- Coordinate product registration activities across international markets.
- Manage lifecycle activities including variations, renewals, line extensions, and regulatory commitments.
Regulatory Intelligence
- Monitor changes in global regulatory frameworks and industry requirements.
- Assess regulatory trends and their impact on products and business operations.
- Maintain awareness of developments related to EMA, FDA, ICH, Swissmedic, MDR, and IVDR requirements.
Your Profile
- Master's degree or PhD in Pharmacy, Life Sciences, Biotechnology, Chemistry, Biomedical Engineering, Regulatory Affairs, or a related scientific discipline.
- Minimum 5 years of experience in Regulatory Affairs within Pharmaceutical, Biotechnology, Combination Products, or Medical Device environments.
- Proven experience in product registrations, licensing activities, and lifecycle management.
- Strong knowledge of international regulatory requirements and regulatory submission processes.
- Experience working with one or more of the following frameworks:
- EMA
- FDA
- Swissmedic
- ICH Guidelines
- EU MDR / IVDR
- GMP and GDP environments
Preferred Experience
We are particularly interested in candidates with exposure to one or more of the following areas:
- Medical Devices
- In Vitro Diagnostics (IVD)
- Pharmaceuticals
- Sterile Manufacturing
- CMC Regulatory Affairs
- Product Registrations and Licensing
- Global Regulatory Strategy
Fluent English is mandatory.
French and/or German would be a strong asset.
Localisation : Basel Area or French-Speaking Switzerland
