Overview
Quality & Regulatory Dossier Compliance Specialist (m/f/d) at Adragos Pharma. The role supports regulatory compliance and contributes to the submission and maintenance of national and international authorisations for customers. It operates under the guidance of a Quality & Compliance Systems Team Leader and involves collaboration with cross-functional teams and customers to ensure timely and accurate regulatory deliveries and routine dossier compliance.
Responsibilities
* Work with internal teams and customers to 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, MAHs, and ensure high-quality submissions.
* Compare product manufacturing and testing particulars against regulatory filings to ensure regulatory compliance.
* Evaluate the 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 / Qualifications
* Bachelor’s degree in a 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.
Job Details
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Other
Contact
If you recognize yourself in this profile, please send your complete application to rh-jura@adragos-pharma.com.
We thank all candidates for their interest; however, only those selected for an interview will be contacted. Adragos Pharma - BACCINEX SA – Rue de la Source 3 – 2822 Courroux – Switzerland.
About Us
Adragos Pharma is a Contract Development and Manufacturing Organization (CDMO) with production sites in Germany, France, Greece, Norway, Japan, and Switzerland. Founded in 2020, the group has 900+ professionals and is expanding across Europe, North America, and Japan to become a global leader in the CDMO sector.
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