Manager CMC Strategy

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 Manager, CMC Strategyy? This position is located in our King of Prussia PA office. It is a Hybrid role. You will report to the Director GRA, North America

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

• Develop the establishment and maintenance of high quality relationships with regional health authorities and collaborating with respective GRA Global Regulatory Leads (GRLs) (Global Product Strategy or CMC) and team members to enhance these relationships.

• Contribute to regulatory account for changes in relevant CMC regulations / laws affecting CSL’s business within the Region North America and providing regulatory assessment of these changes.

• Assure a productive collaboration with important team members, such as global CMC, to ensure successful development, strategic agreement and execution of regional regulatory strategies that result in successful applications for assigned products, from early development to Marketing Authorization (MA), and for any post MA submissions. 

• Contribute to CMC regional regulatory perspective to the global regulatory strategy and aligning regional strategies with the global strategy throughout the product lifecycle for assigned products. 

• You will guide comprehensive, globally aligned regulatory activities within GRA NA for assigned products throughout development and after commercialization.  

• A bachelor’s degree,in Science or Pharmacy. A post-graduate qualification is advantageous. 

• 5 years of experience in the pharmaceutical industry in Biologics/Research & Development, some experience may be accounted for with advanced degree.

• 1+ years of experience in regulatory CMC, supported by additional pharmaceutical/industry experience.

• Awareness of regulatory CMC guidelines and legislative requirements for US FDA. 

• Knowledge of GMP, GCP and GLP requirements.

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.

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.

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