The Opportunity

CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.

With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.

Could you be our next Associate of Global Regulatory Affairs? This position is located in our King of Prussia PA office. It is a Hybrid role. You will report to the Global Regulatory Lead.

The Associate Regulatory GRA Region North America (GRA Region NA) is a member of a Regional Therapeutic Area Team and contributes to the vision and goals for Global Regulatory Affairs (GRA) by:

• Executes on the technical requirements with the region according to the re gional requirements and timelines.
• Maintains dossiers as assigned across the product life cycle.
• Contributing to regulatory to highlight changes in relevant regulations / laws affecting Regulatory Affairs in the North America region and providing regulatory review and interpretation of these changes.
• Collaborates and aligns with respective GRA Region NA representatives on submission plans and deliverables for assigned projects.

The Role

• Support the compilation and submission of high-quality documentation such as new license applications, change applications, labeling submissions, license renewals, clinical trial applications/INDs, pediatric plans, orphan drug designations, product identifiers/names, tenders, periodic reports, health authority meetings following agreed schedules, taking into account regional specific requirements.

• You will prepare Module 1 documents for assigned projects, including generation of templates.

• You will work with GRA Region NA managers to plan, track, compile and submit high-quality documentation according to regional requirements and timelines.

Your experience

• A bachelor’s degree in Science or Pharmacy

• 12 months of experience in the pharmaceutical industry or related industry, regulatory affairs experience

• Experience with Veeva or Docnet

BENEFITS

• Medical, Dental Vision

• 401K

• Paid time Off

#LI-Hybrid

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

Do work that matters at CSL Behring!