Swiss Regulatory Affairs Specialist

Your Role Working in a Pharma team, you will be supporting the EMEA divisions on topics around the supply of raw materials into the pharmaceutical industry including regulatory, legal, compliance, quality and product safetyresponsibilities

Responsibilities

Your responsibilities will bei Completion of technical and regulatory documentation and information requests from customers for supply of raw materials into the pharmaceutical industry (questionnaires, supply chain agreements, quality agreement and technical agreements) in and English.

Sourcing information internally and from suppliers to satisfy customer requests.

Reporting and documenting customer requests via KPIs.Collaborating with commercial and value-added services teams, proactively leading and managing regulatory topics related to customer projects.

Collaborating with QHSE & supply chain teams to ensure regulatory compliance and support with current standards and implementation of new standards (IPEC GMP/GDP, EXCiPACT, GDP etc).Collaborating within the Pharma Regulatory team on global business unit projects.

Creation and management of product regulatory information in standardized format.

Providing training on regulatory relevant topics to commercial and supply chain team.

Any other tasks within capability to support the commercial success of the Pharma business unit.

Your Profile

You will have:

A degree or considerable experience in life sciences.

Knowledge of pharmaceutical industry requirements and regulations on APIs, excipients, biopharma, and traditional pharma raw materials.

Knowledge of Swiss Medic and other European National Competent Authority requirements for distribution of APIs, Excipients, and raw materials to the pharmaceutical industry.

Fluent in English & German/Swiss German (speaking and written).You are a good collaborator & effective communicator with the ability to work proactively across all levels and functions.

You understand current regulations around raw materials using within traditional Pharma and Biopharma, and have the ability to resolve compliance issues and respond to complex regulatory queries.

You are flexible in adapting to changing regulations, industry standards, and project demands.

Our Offer You will work in an European team with members all over Europe, and will be working from preferably our Ballerup office.

We will offer a competitive and fair salary, a good pension plan and health insurance.

Brenntag provides equal employment opportunities to qualified applicants and employees of all backgrounds and identities to create a workplace where difference is valued because it forms a resilient and more innovative organization. We do not discriminate on the basis of age, disability, gender identity, sexual orientation, ethnicity, race, religion or belief, parental and family status, or any other protected characteristic. We welcome applications from women, men and non-binary candidates of all ethnicities and socio-economic backgrounds.

Brenntag TA Team
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