Regional Regulatory Lead (Therapeutic area Immunology, Respiratory, Transplant)

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Regional Regulatory Lead (Therapeutic area Immunology, Respiratory, Transplant)

We make it GmbH is a company operating nationally in Switzerland which, thanks to many years of successful experience, has a high level of expertise in the personnel services sector.

Its recruitment activities are focussed on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH places the highest demands on quality, ethics and discretion.

For our client, CSL Behring based in Bern, we are looking for an Regional Regulatory Lead (m/f/d).

Regional Regulatory Lead (Therapeutic area Immunology, Respiratory, Transplant)

Background

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies that treat coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease, and neurological disorders. The company’s products are also used in cardiac surgery, burn treatment and to prevent hemolytic disease of the newborn.

Tasks

• Serve as a Regional Regulatory Lead for the assigned product portfolio (Therapeutic area Immunology, Respiratory, Transplant) and countries.
• Align all regulatory activities with regional and global strategies, ensuring compliance with local requirements.
• Communicate effectively to ensure that dossiers meet regional and local content and format requirements.
• Coordinate, compile and track high-quality documentation for submissions, including new license applications and lifecycle activities to enhance connectivity and improve submission and approval timelines. This also involves addressing questions related to regulatory submissions.
• Build strong relationships with regional regulatory agencies, utilizing negotiation and influencing skills for positive outcomes.
• Collaborate with internal functions (e.g., Commercial, Manufacturing, Supply Chain, and Medical Affairs) to enhance connectivity.
• Stay informed about international legislation and guidelines for biological products and related initiatives (e.g., rare diseases, orphan drugs).

Requirements

• A degree in Life Sciences, preferably with a post-graduate qualification. Degree e.g. in Drug Regulatory Affairs advantageous.
• At least 3 years of regulatory experience within the international region, supported by additional pharmaceutical /industry experience.
• Understanding of the scientific principles and technical requirements relevant to the development of a pharmaceutical product and understanding of the principles of GMP and GCP.
• Proficiency in standard regulatory tools : Veeva, DocNet, Trackwise
• Attendance at CSL office at least 20%

Work hours

• Standard 41 h/ Week

Are you interested?

Then Mr. Andre Amstad looks forward to receiving your complete application documents (CV, references and training certificates).

Please apply by e-mail to Write an email

We look forward to hearing from you.