Germany_Senior Associate Regulatory Affairs (m/f/d)
Job Description
Celltrion Group provides biosimilar and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world.
Celltrion Group offers biologics to about 110 countries, along with more than 30 global partners around the world. With hands-on experience and knowledge accumulated through years of working in the advanced pharmaceutical markets around the world, Celltrion Group has been securing distribution channels and providing patients with biosimilars at affordable prices.
Location: Bad Homburg (Office-based)
Department: Regulatory Affairs / QM
Full-time
About the Role
We are looking for a motivated and detail-oriented Senior Associate Regulatory Affairs to strengthen our Regulatory Affairs team in Germany. In this role, you will work closely with international and cross-functional teams to ensure regulatory compliance throughout the product lifecycle and to support efficient implementation of global regulatory strategies at national level.
This position offers the opportunity to work in a dynamic, international environment within the pharmaceutical industry and to contribute actively to maintaining high regulatory and ethical standards.
Key Responsibilities
Close cooperation with the Global Regulatory Affairs team and implementation of global regulatory guidelines at national level
Review and maintenance of product information texts, artworks and preparation of Blue Box information
Support of global regulatory activities to ensure efficient, compliant business processes in collaboration with cross-functional teams
Contribution to the preparation of educational and training materials
Support the update, implementation and maintenance of all regulatory-relevant documents and materials at national level, ensuring timely availability
Preparation and maintenance of regulatory documents such as SmPCs, Patient Information Leaflets, mandatory texts, Blue Hand materials, safety data sheets and batch release waivers
Tracking the implementation and use of updated product information by internal teams and external service providers
Maintenance and update of external databases and portals (e.g. Rote Liste, Gelbe Liste, ABDATA, ifap, IFA)
Monitoring regulatory developments, new requirements and trends, including screening of authority newsletters and product websites
Providing regulatory updates and ensuring effective information flow to internal stakeholders (Market Access, Medical, Marketing, Quality)
Artwork management and lifecycle management of product information
Ensuring compliance with internal and external regulatory standards
Close cross-functional collaboration with Quality, SCM, Medical, Pharmacovigilance, Market Access and Marketing
Maintenance of a clear and standardized filing and archiving system for regulatory documents and correspondence
Qualifications & Experience
Bachelor’s degree or equivalent qualification, preferably in applied science or a related field
Professional experience in Regulatory Affairs within the human or animal health/pharmaceutical industry
Experience working with regulatory information systems, databases and international stakeholders
Very good communication skills in German (C1) and good working proficiency in English (B1)
Proficiency in MS Office applications
Structured, accurate and highly organized way of working
Service-oriented mindset and strong team spirit
Personal Profile
Strong motivation and willingness to “make things possible” with a hands-on attitude
High personal integrity, ethical standards and reliability
Agile mindset with flexibility and ability to work independently
Strong communication skills and high level of team orientation
Proactive, positive and solution-focused approach
What We Offer
An international and collaborative working environment
Broad exposure to global regulatory activities
Opportunities for professional development and growth
A role with responsibility and impact in a highly regulated industry
Lunch vouchers to support daily meals
Company pension scheme
JobRad (company bike leasing program)