Position Summary:

The Senior Director, Regulatory Therapeutic Area Lead in Global Product Strategy (GPS) is a member of the Global Regulatory Affairs (GRA) GPS Leadership Team and contributes to the vision and goals for GRA by:

• Providing innovative scientific and regulatory vision, leadership and oversight for an assigned therapeutic area by defining aligned global regulatory strategies and activities for CSL Behring's developmental portfolio and core regulatory support for established products without ongoing clinical development, and accountable for non-clinical, clinical and safety content globally of CSL's regulatory documentation.
• Leading and coaching associated direct reports (as applicable) at CSL's global facilities, such as in the USA, UK, Italy, Netherlands, Germany, Switzerland, Australia, and Japan.
• Assuring a productive collaboration with key internal TA stakeholders, such as research, early and late stage clinical development, commercial development, safety and project management leads, to ensure successful development, strategic alignment and execution of global regulatory strategies that result in successful applications for CSL's product portfolio, from early development to Marketing Authorization (MA), and for any post MA submissions clinical line extensions.
• In collaboration with GRA Regional leads, supporting the establishment and maintenance of high-quality working relationships with the FDA, EMA, PMDA and other global regulatory agencies for CSL's TAs.
• Leading the GRA TA Team with a focus on collaborating and decision making for the TA with GRA functional TA & Site Leads, as appropriate.
• Representing the GRA TA as a core member of the R&D-wide Therapeutic Area Leadership Team (TALT).

Main Responsibilities and Accountabilities: -

• Work closely with the Head, GRA GPS to maintain an effective, globally minded, GRA organization that is focused on utilizing creative problem-solving skills, risk-based approach, can clearly articulate the science and regulatory perspective to stakeholders, regardless of level, and supports effective Global Regulatory Affairs Strategy Team/s (GRAST) for assigned TA.
• Contributes to the GRA GPS Leadership Team (GPS LT), appropriately engages with the GRA Regulatory Forum (Reg Forum) and represents GRA as a core member of the R&D-wide Therapeutic Area Leadership Team (TALT).
• Accountable to provide innovative scientific and regulatory leadership by defining and executing a unified global regulatory strategy for assigned TA to enable successful submissions and approvals during all phases of development (prior Phase IIV). Ensure understanding and alignment of the global regulatory strategy amongst the GRA TA team.
• Empower and advise the members of GRA GPS TA to ensure that all functional project deliverables for assigned portfolio are met. Additionally, provide strategic and tactical regulatory leadership and guidance for direct reports, as appropriate.
• Accountable for non-clinical / clinical / safety related content of all submissions and interactions with the FDA, EMA and other Regulatory Agencies for assigned TA, working with and through the regional leads (ICH and International Regions). Participate in Health Authority meetings, as required.
• Enable growth and professional development of the GRA GPS team members, including succession planning for critical roles with LT. Ensures all team members have been trained on their role.
• Responsible to lead the GRA TA Team to assure the delivery of innovative and competitive solutions to accelerate program development, prioritize activities, drive decision making, manage risks and increase success rate for TA activities. Collaborates with partner GRA TA /Site Leads and represents GRA at respective governance for assigned TA.
• Implement and maintain global regulatory processes and operations for GPS, including GRAST operations. Implement/utilize electronic systems in line with GRA Operational Excellence.
• On behalf of GRA, reviews and approves Target Product Profiles (TPPs) and Target Product Claims (TPCs) for the TA product portfolio. Leads TA-related regulatory due diligences/divestitures.
• When acting as a GRL, serve as the primary Regulatory Interface on the Product Strategy Team (PST), Clinical Development Team (CDT) and Safety Management Team (SMT) for GRA, advocate and drive the 'one GRA' perspective with team stakeholders. Accountable for non-clinical / clinical / safety related regulatory submission content globally for assigned products.

Qualifications and Experience: -

• A bachelor's degree (four-year university degree) in pharmacy, biology, chemistry, pharmacology, clinical medicine or related life science is required. An advanced degree in a related field (MS, PhD or MD, DVM) or MBA is preferred. Ideal candidates will have a strong clinical foundation.
• Minimum of 15 years' experience in the biotech or pharmaceutical industry, with at least 10 years in Regulatory Affairs
• Experience in leading and managing teams (Minimum 7 years), setting clear direction, holding people accountable and fostering a collaborative team environment.
• Candidates must have thorough knowledge and understanding of pharmaceutical/biological product development and regulatory requirements for product development and approval in more than one key region (EU, US, Japan)
• Experience working in Regulatory Affairs in a global environment across two or more geographic areas (preferentially US and EU).
• Extensive experience interfacing with regulatory agencies and proven skill at developing and implementing successful global regulatory strategies.
• Experience working in a complex and matrix environment is required
• Demonstrated experience in working with multiple stakeholders.

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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 .

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