Associate Director, Global Regulatory Affairs Region

2 weeks ago

King of Prussia Pennsylvania, Montgomery County, PA, United States CSL Behring Full time

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 Director, Global Regulatory Affairs? The job is located in our King of Prussia PA office. This is a hybrid position. You will report to the Director of Global Regulatory Affairs.

Responsibilities:

You are a member of a Regional Therapeutic Area Team and contributes to the vision and goals for Global Regulatory Affairs (GRA) by:

  • Support the GRA Region regulatory teams for cross-TA support for guidance and best practice. Be a delegate for the TA lead.

  • Leading the establishment and maintenance of high-quality relationships with regional health authorities and collaborating with respective GRA Global Product Strategy (GPS) TA Leads & GRA CMC Site Leads to enhance these relationships. May serve as the CSL Behring primary contact for health authorities for products within the portfolio.

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

  • Assure a productive collaboration with important team members, 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.

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

  • Guide. facilitate comprehensive, commercially and globally aligned regulatory activities within GRA NA for assigned products throughout development and after commercialization.

  • Be a GRA NA representative for assigned projects to the Global Regulatory Affairs Strategy Team (GRAST) to provide regional input into the delivery of, science-based and globally aligned regulatory strategy with GRL.

  • Accountable for CSL Behring’s relationship with respective health authorities within the region. Ensure working relationships are established and maintained with regional health authorities and negotiate with these authorities to achieve positive outcomes for CSL Behring. To support this objective, leads US FDA meetings and uses global GRA functions.

  • Use global GRA functions to support our goals. Use expertise in US regulatory affairs, coupled with a global perspective, to ensure that new trends are addressed to influence the regional regulatory strategy with the global regulatory strategy

EXPERIENCE:

  • Bachelor’s degree in Science or Pharmacy, is required.

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

  • 7+ 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 regulations.

BENEFITS

  • Medical, Dental Vision

  • 401K

  • Paid time Off

#LI-HYBRID

Our Benefits

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what’s available to you as a CSL employee.

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.

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