Senior Manager, Regulatory Affairs

CSL Seqirus was created from the combined strength and expertise of bioCSL and the influenza vaccines business formerly owned by Novartis. In July 2015, the two businesses joined forces to create CSL Seqirus, now the second largest influenza vaccine company in the world. With research and production expertise and manufacturing plants in the US, UK, Germany and Australia, CSL Seqirus is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. CSL Seqirus has a workforce of over 3,000 employees, manufacturing capacity and a commercial presence in over 20 countries.

Could you be our next Senior Manager of Regulatory Affairs? This is a hybrid opportunity at our Holly Springs, Waltham MA, or King of Prussia PA location. You will report to the Regional Regulatory Therapeutic Area Lead.

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

• You will be the primary CSL representative to regional health authorities for assigned products.
• You will 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.
• You will also contribute to regulatory to account for changes in relevant regulations / laws affecting CSL’s business within the Region North America and Canada providing regulatory assessment of these changes.
• You will assure a productive collaboration with your team, such as Regional commercial operations, 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. 
• You will contribute 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 facilitate comprehensive, commercially and globally aligned regulatory activities within GRA NA for assigned products throughout development and after commercialization.  
• You will be a GRA NA representative for assigned projects to the Global Regulatory Affairs Strategy Team (GRAST) to provide regional input into the delivery of thoughtful, science-based,, and globally aligned regulatory strategy together with GRL.

• A bachelor’s degree in Science or Pharmacy. A post-graduate qualification is advantageous. 
• 7+ years of experience in the pharmaceutical industry, advantageous if in Vaccines/Biologics/Research & Development, some experience may be accounted for with advanced degree.
• 3+ years of experience in regulatory, supported by additional pharmaceutical /industry experience. Direct regulatory-facing experience.
• Working knowledge of regulatory guidelines and legislative requirements for US FDA and Health Canada guidance/regulations. 
• Experience in negotiations and facilitating resolution of issues with regulatory agencies and with positive outcomes.

#LI-Hybrid

Our Benefits

Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.

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