Regulatory affairs director Jobs in Dautphetal

For our Global Regulatory Affairs department, we are looking for a

Global Regulatory Affairs CMC Manager / Senior Manager (100%) in the Immunology & Immunoglobulins Team (m / f / x)

R-248105

Fulltime / permanent / non-tariff

Do you want to work in a global team and support regulatory strategies of plasma-derived products in all phases of development, from preclinical to post approval phase?

The Global Regulatory Affairs CMC department is responsible to oversee all relevant regulatory CMC aspects in each portfolio of products. The role of GRA CMC Manager / Senior Manager is part of a global team responsible for the plasma-derived products within the Immunology and Immunoglobulins therapeutic area. She / he is responsible for the CMC lifecycle management of the multiple licenses of the plasma-derived products and to support the worldwide registration of established products. The position holder will collaborate with internal and external stakeholders and interface with Research and Development, Global Manufacturing and Global Quality.

The Opportunity

• Develops and executes global regulatory strategies in close collaboration with quality, manufacturing, research and development departments to support clinical trials, NDA / MAA and post-approval phases.
• Leads regulatory teams for CMC projects / programs to align global strategies with regional regulatory requirements.
• Represents the Global Regulatory Affairs function GRA CMC in cross-functional project teams.
• Responsible for the content of regulatory submissions worldwide, meeting appropriate standards and content requirements.
• Prepares, revises, and reviews CMC relevant CTD narrative for lifecycle management submissions according to agreed timelines and taking regional regulatory requirements into account.
• Plans, coordinates, and contributes to the compilation of responses to Health Authority questions in collaboration with the relevant subject matter experts and according to the schedule agreed in the regulatory team.
• Provides regulatory contribution to annual product quality reviews and risk assessments.
• Drives storyboard, Health Authority meetings requests and background information documents, contributes to the preparation, and participates at Health Authority meetings related to assigned projects / programs.
• Compiles CMC documentation or coordinate the compilation of documents in close collaboration with subject matter experts in preparation of Health Authority meetings.
• Evaluates the available technical and scientific CMC information for compliance with regulatory requirements, performing gap analysis and proposing solutions and strategies to remediate risks.
• Provides regulatory support during international Health Authority inspections.
• Provides support to conduct compliant regulatory assessment of changes.

Your Skills and Experience

What we offer

For more information, please check out our global benefits below

We are looking forward to your application. Please ensure to apply online with your CV and certifications as well as your salary expectation.

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL Behring!