Regulatory Affairs Specialist  

For one of our esteemed clients, international pharmaceutical and biotech company focused on specialty medicinal products, we are looking for a Regulatory Affairs Specialist to strengthen its Regulatory team.

This position offers the opportunity to work in an international regulatory environment and contribute to the lifecycle management of medicinal products across multiple markets.

Key Responsibilities

• Preparation and management of regulatory submissions in eCTD format

• Lifecycle management activities including variations, renewals and maintenance of Marketing Authorisations

• Preparation and review of regulatory documentation and product information (SmPC, PIL, labeling)

• Coordination of submission dossiers for international markets

• Interaction with internal departments (QA, CMC, Clinical, Pharmacovigilance)

• Ensure compliance with international regulatory requirements

• Management and compilation of eCTD sequences using regulatory publishing tools

Requirements

• Degree in Life Sciences (Pharmacy, Biotechnology, Chemistry or related fields)

• 4–5 years of experience in Regulatory Affairs within the pharmaceutical industry

• Proven experience with medicinal products regulatory dossiers

• Mandatory experience working with eCTD tools (experience with EXTEDO is highly preferred)

• Hands-on experience with international submissions, variations and lifecycle management

• Ability to work independently on regulatory documentation and product information

• Professional English language proficiency

What the company offers

• Permanent contract

• Opportunity to work in an international pharmaceutical environment

• Exposure to global regulatory activities

• Hybrid work model (1 day per week remote work)

• Collaborative and scientifically driven working environment

Gi Life Science is part of Gi Group Holding, a global ecosystem of HR services and consulting that supports the development of the labour market and helps to change people's lives in 37 countries around the world. In Switzerland we operate with the brands Gi Life Sciences, Gi Group, Grafton and Bautech Personal. We are active in temporary, permanent and professional staffing as well as in a variety of complementary HR Services. With a direct presence in 40 locations across Switzerland and over 200 employees, we are one of the leading staffing companies in the Swiss recruitment market. Gi Life Sciences is specialist for Temporary and Permanent staffing in the Life Science sector, as well as a valuable partner for many other HR Solutions. We believe in experts talking to experts: all our professionals are certified in scientific sector, meaning that they are able to understand your needs and support you at 360°.