BioSpace
Senior Manager Regional Regulatory Lead - US (Hematology)
BioSpace, King Of Prussia, Pennsylvania, United States, 19406
Senior Manager Regional Regulatory Lead - US (Hematology)
Location: King of Prussia, PA. This is a hybrid position onsite three days a week. Report to the Executive Director Head Regulatory.
CSL Behring is seeking a Regulatory leader to contribute to an innovative, scientifically sound, global regulatory strategy for assigned product(s) with a patient-centric focus, leveraging regional commercial insights and prudent risk-taking to deliver timely regulatory outcomes.
Key responsibilities and accountabilities:
Accountable for the assigned product relationship with a health authority (FDA or EMA), ensuring alignment with the product GRL and supporting from the Head, Regulatory TA when escalation is required. Lead assigned negotiations with health authorities to achieve desired regulatory outcomes.
Develop regional expertise on health authority requirements, regulatory filing pathways/categories, processes, and ways of working. Provide guidance to internal stakeholders (e.g., GRAST, GRL & Commercial) on addressing project challenges, leveraging regulatory opportunities, and advising on risk for developmental, new, and marketed products.
Under the product GRL, contribute to regional regulatory activities, including core document preparation (e.g., core briefing books, pediatric plans), product filing preparation (investigational, new, and marketed) and health authority engagements. Responsible for Module 1 documentation and support responses to authority comments with GRL guidance.
Actively contribute to GRAST activities, strategy development, document reviews, and competitive regulatory intelligence. Ensure on-time execution of regional regulatory activities, and partner with GRL to communicate with regional commercial stakeholders. Maintain relationships with GRAST members, including GRAS Regions and Regulatory CMC.
Support development of CSL policy positions as needed and promote effective relationships across Global Regulatory Strategy. Update regulatory systems (e.g., Veeva) to ensure tracking and compliance deliverables.
Qualifications & Experience Requirements
Bachelor’s degree (four-year university) in pharmacy, biology, chemistry, pharmacology, clinical medicine or related life science. An advanced degree (MS, PhD, MD, DVM) or MBA is preferred.
Minimum of 7 years’ experience in biotech or pharmaceutical industry, with at least 5 years of regulatory experience, including 3 years on developmental products.
Experience working in teams with direct or matrix management; ability to assess options for tough decisions.
Developing knowledge of regulatory requirements for product development and approval in one key region (EU, US, Japan).
Experience in Regulatory Affairs with agency interaction responsibility with at least one health authority.
Experience in a complex and matrix environment is preferred; clinical or device foundation is a plus.
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. Our benefits support health care, financial protection, and resources for various life stages and needs.
About CSL Behring
CSL Behring is a global biotherapeutics leader focused on serving patients’ needs by discovering, developing, and delivering innovative therapies in immunology, hematology, cardiovascular/metabolic, respiratory, and transplant areas. CSL Behring operates CSL Plasma and is part of CSL, a global company with about 32,000 employees in more than 100 countries.
Inclusion and Belonging
At CSL, Inclusion and Belonging are core to our mission and who we are. We celebrate differences and foster a culture of curiosity and empathy to better serve patients and stakeholders and sustain a diverse workforce for the future.
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CSL Behring is seeking a Regulatory leader to contribute to an innovative, scientifically sound, global regulatory strategy for assigned product(s) with a patient-centric focus, leveraging regional commercial insights and prudent risk-taking to deliver timely regulatory outcomes.
Key responsibilities and accountabilities:
Accountable for the assigned product relationship with a health authority (FDA or EMA), ensuring alignment with the product GRL and supporting from the Head, Regulatory TA when escalation is required. Lead assigned negotiations with health authorities to achieve desired regulatory outcomes.
Develop regional expertise on health authority requirements, regulatory filing pathways/categories, processes, and ways of working. Provide guidance to internal stakeholders (e.g., GRAST, GRL & Commercial) on addressing project challenges, leveraging regulatory opportunities, and advising on risk for developmental, new, and marketed products.
Under the product GRL, contribute to regional regulatory activities, including core document preparation (e.g., core briefing books, pediatric plans), product filing preparation (investigational, new, and marketed) and health authority engagements. Responsible for Module 1 documentation and support responses to authority comments with GRL guidance.
Actively contribute to GRAST activities, strategy development, document reviews, and competitive regulatory intelligence. Ensure on-time execution of regional regulatory activities, and partner with GRL to communicate with regional commercial stakeholders. Maintain relationships with GRAST members, including GRAS Regions and Regulatory CMC.
Support development of CSL policy positions as needed and promote effective relationships across Global Regulatory Strategy. Update regulatory systems (e.g., Veeva) to ensure tracking and compliance deliverables.
Qualifications & Experience Requirements
Bachelor’s degree (four-year university) in pharmacy, biology, chemistry, pharmacology, clinical medicine or related life science. An advanced degree (MS, PhD, MD, DVM) or MBA is preferred.
Minimum of 7 years’ experience in biotech or pharmaceutical industry, with at least 5 years of regulatory experience, including 3 years on developmental products.
Experience working in teams with direct or matrix management; ability to assess options for tough decisions.
Developing knowledge of regulatory requirements for product development and approval in one key region (EU, US, Japan).
Experience in Regulatory Affairs with agency interaction responsibility with at least one health authority.
Experience in a complex and matrix environment is preferred; clinical or device foundation is a plus.
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. Our benefits support health care, financial protection, and resources for various life stages and needs.
About CSL Behring
CSL Behring is a global biotherapeutics leader focused on serving patients’ needs by discovering, developing, and delivering innovative therapies in immunology, hematology, cardiovascular/metabolic, respiratory, and transplant areas. CSL Behring operates CSL Plasma and is part of CSL, a global company with about 32,000 employees in more than 100 countries.
Inclusion and Belonging
At CSL, Inclusion and Belonging are core to our mission and who we are. We celebrate differences and foster a culture of curiosity and empathy to better serve patients and stakeholders and sustain a diverse workforce for the future.
#J-18808-Ljbffr