- You will provide leadership to the respective Regional Team, overseeing all regional regulatory strategic and operational tasks for licensed products and development projects concerning the assigned therapeutic area.
- Lead the establishment and maintenance of high quality relationships with regional health authorities and other external partners.
- Maintain collaborative relationships with respective GPS, GRA CMC and other GRAST members to help develop assigned products/projects.
- Works with Global Regulatory Therapeutic Area Leads and their teams and other Global Regulatory Affairs Strategy Team (GRAST) members to manage and resolve issues.
- Ensure strategic regional regulatory input which is in consideration of the commercial strategy and is provided into global regulatory teams and that the Regional Regulatory TA Team supports the Global Regulatory Affairs (GRA) vision of excellence, good scientific practice, integrity and compliance with regulatory standards.
- Shape and build commercially and globally aligned regulatory activities/strategies within the region for CSL's product portfolio throughout development and after commercialization by using, science-based regulatory strategies.
- Facilitate productive collaboration with important company partners, such as Regional commercial operations and affiliate regulatory affairs, to ensure successful development, strategic agreement and execution of regional regulatory strategies that result in successful applications for assigned therapeutic area, from early development to Marketing Authorization (MA), and for any post MA submissions.
- You will contribute to the Regional regulatory account for changes in relevant regulations / laws affecting CSL business within the region and assess these changes for impact to the business and CSL's product portfolio.
- Collaborate and align with GRA functional TA & Site Leads, including exchanging information on relevant topics. Be the regional representative for the GRA Therapeutic Area Team(s) for assigned therapeutic area(s).
- Develop and guide staff within the assigned therapeutic area to help develop the regional regulatory strategy and provide direct support.
- Bachelor's degree in Science or Pharmacy; post-graduate degree is advantageous
- At minimum 10 years' experience in the pharmaceutical industry in Biologics/Research & Development/Regulatory Affairs. Some experience may be accounted for with advanced degree.
- At least 7 years of regulatory experience and experience in a regulatory authority facing role, supported by additional pharmaceutical /industry experience.
- Experience leading negotiations and facilitating resolution of issues with regulatory agencies and with positive outcomes.
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Director of Regional Regulatory Vaccines Lead - Summit, United States - BioSpace
Description
Job DetailsCSL 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 Director of Regional Regulatory Vaccines Lead? The job is located in the Summit NJ or King of Prussia office. This is a hybrid position. You will report to the Head, GRA Region North America
The Role
The Global Regulatory Affairs (GRA) Region North America Therapeutic Area Lead (Vaccines) is a member of the GRA Regional Leadership Team and contributes to the vision and goals for Global Regulatory Affairs (GRA) by:
Medical, Dental Vision
401K
Paid time Off
#LI-HYBRID
Our Benefits
CSL Seqirus 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 Seqirus 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 Seqirus 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 Seqirus employee.
About CSL Seqirus CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL Seqirus .
We want CSL Seqirus 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 Seqirus.
Do work that matters at CSL Seqirus
Watch our 'On the Front Line' video to learn more about CSL Seqirus
