Quality & Regulatory Dossier Compliance Specialist (m/f/d)

Festanstellung, Vollzeit · Courroux, Suisse

Our offer

Founded in 2000, Baccinex SA is part of the Adragos Pharma Group, headquartered in Courroux, Switzerland (30 minutes from EuroAirport Basel Mulhouse Freiburg). The Courroux site is multifunctional, specialized in manufacturing parenteral products, it employs over 100 employees, and is recognized as a European leader in the manufacture and supply of clinical trial medications.
Adragos Jura is seeking a Regulatory Dossier Compliance Specialist to support regulatory compliance and contribute to the submission and maintenance of national and international authorizations for our customers. The role will operate under the guidance of a Quality & Compliance Systems Team Leader and will involve collaboration with cross-functional teams both internally and with customers to ensure timely and accurate regulatory deliveries, and routine dossier compliance.

Your mission

Working with internal teams and our customers, support the preparation, submission, and maintenance of product registrations across global markets (EU, Switzerland, FDA, and Rest of World).
Independently and critically review regulatory documentation for marketing authorization applications (MAAs), to support variations, renewals, and other regulatory activities.
Coordinate with internal departments, local partners, Marketing Authorization Holders (MAHs), ensure high-quality submissions.
Compare product manufacturing and testing particulars against regulatory filings to ensure comfortable compliance.
Evaluate impact of Change Controls and CAPAs on the MAAs of customers.
Help maintain registration documentation in alignment with the latest regulatory guidelines and health authority expectations.

Your profile

Bachelor’s degree in scientific discipline (Pharmaceutical Sciences, Chemistry, Biology, or related field).
Minimum of 4–5 years of experience in Regulatory Affairs within the pharmaceutical industry.
Solid understanding of pharmaceutical legislation and regulatory frameworks.
Proven experience with EU registration procedures (MRP/DCP MAAs, variations, extensions, and renewals).
Previous experience with non-EU registrations is an advantage.
Strong organizational and planning skills.
Ability to interpret and effectively communicate regulatory requirements.
Proactive, detail-oriented, and capable of working independently.
Strong interpersonal and team collaboration skills; able to manage deadlines effectively.
Proficient written and verbal communication skills in English.
Bilingual English and French
High attention to detail and a commitment to quality.

Contact

If you recognize yourself in this profile, feel free to send us your complete application at: rh-jura@adragos-pharma.com.
We thank all candidates for their interest, but only those selected for an interview will be contacted. Adragos Pharma - BACCINEX SA – Rue de la Source 3 – 2822 Courroux – Switzerland.

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About us

Adragos Pharma is a reliable Contract Development and Manufacturing Organization (CDMO) headquartered in Munich, Germany. We provide comprehensive development and manufacturing services for drug products, including sterile and non-sterile liquids, solids, and semi-solids. Our expertise also covers biologicals, orphan drugs, clinical trials, fill-and-finish, and lyophilization, offering end-to-end solutions from product development to commercial supply.

With production sites in Germany, France, Greece, Norway, Japan, and Switzerland, we ensure high-quality manufacturing across all stages of the drug development process.

Founded in 2020, Adragos Pharma has rapidly grown through an ambitious buy & build strategy, supported by FSN Capital. With a team of over 900 professionals, we are expanding our operations across Europe, North America, and Japan to become a global leader in the CDMO sector.

As a key player in the pharmaceutical industry, CDMOs like Adragos produce 25% of all drugs globally, ensuring access to essential medications. With increasing healthcare demands, we continue to innovate and set new standards in drug manufacturing.

You want to be part of our dynamic growth? Then apply now!

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Wir freuen uns auf Dich!

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