Germany_Senior Associate Regulatory Affairs (m/f/d)

Celltrion Healthcare Co., Ltd.; Germany; On-site; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Lunch vouchers

Company pension scheme

JobRad (company bike leasing program)

Job summary

Celltrion Group in Germany is seeking a Senior Associate Regulatory Affairs to strengthen the regulatory team. You will work with global teams to ensure regulatory compliance throughout the product lifecycle and support national implementation of global strategies.

The role offers interaction with Quality, Medical, Market Access and Marketing, and requires German C1 and English B1 communication, along with experience in regulatory information systems.

Qualifications

• 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.

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.

Skills

German (C1)

English (B1)

Communication skills

Team orientation

Proactive problem solving

Education

Bachelor’s degree

Tools

MS Office

Regulatory information systems

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)