Senior Director Regulatory TA Head - Hematology at CSL Limited in King Of Prussia, PA
The Sr. Director, Regulatory Therapeutic Area Head (TA 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 accountable for non-clinical, clinical and safety content globally of CSL Behring regulatory documentation. Representing the GRA TA as a core member of the R&D-wide Therapeutic Area Leadership Team (TALT). Leading and coaching associated direct reports (as applicable) at CSL Behring's global facilities, such as in the USA, 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 Behring'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 Behring'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. KEY RESPONSIBILITIES 1. 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 approaches, can clearly articulate the science and regulatory perspective to stakeholders, regardless of level, and supports effective Global Regulatory Leads for assigned TA. 2. 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 I-->IV). Ensure understanding and alignment of the global regulatory strategy amongst the GRA TA team. 3. 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. 4. 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. 5. 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. 6. Contributes to the GRA GPS Leadership Team (GPS LT), appropriately engages with the GRA Global Regulatory Forum (RegForum) and represents GRA as a core member of the R&D-wide Therapeutic Area Leadership Team (TALT). Leads GRA Therapeutic Area Team for respective TA. 7. On behalf of GRA, reviews and approves Target Product Profiles (TPPs), Target Product Claims (TPCs) and other TALT documentation for the TA product portfolio. Leads TA-related regulatory due diligences/divestitures. 8. Implement and maintain global regulatory processes and operations for GPS, including GRAST operations. Implement/utilize electronic systems in line with GRA Operational Excellence. 9. If 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. 10. Lives and advocates with team members CSL Leadership Principles, including:
Driving Performance, Building Productive Teams, Developing People and Creating the Future. EDUCATION A bachelor degree (equivalent to a 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. EXPERIENCE Minimum of 15 years' experience in the biotech or pharmaceutical industry, with at least 10 years in Regulatory Affairs and direct experience with clinically regulatory regulatory activities. Experience in leading and managing teams (Minimum 7 years), setting clear direction, holding people accountable and fostering a collaborative team environment within a matrix workplace. 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) Extensive experience interfacing with regulatory agencies and proven skill at developing and implementing successful global regulatory strategies
Salary Range:
$250K -- $500K+
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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 accountable for non-clinical, clinical and safety content globally of CSL Behring regulatory documentation. Representing the GRA TA as a core member of the R&D-wide Therapeutic Area Leadership Team (TALT). Leading and coaching associated direct reports (as applicable) at CSL Behring's global facilities, such as in the USA, 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 Behring'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 Behring'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. KEY RESPONSIBILITIES 1. 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 approaches, can clearly articulate the science and regulatory perspective to stakeholders, regardless of level, and supports effective Global Regulatory Leads for assigned TA. 2. 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 I-->IV). Ensure understanding and alignment of the global regulatory strategy amongst the GRA TA team. 3. 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. 4. 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. 5. 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. 6. Contributes to the GRA GPS Leadership Team (GPS LT), appropriately engages with the GRA Global Regulatory Forum (RegForum) and represents GRA as a core member of the R&D-wide Therapeutic Area Leadership Team (TALT). Leads GRA Therapeutic Area Team for respective TA. 7. On behalf of GRA, reviews and approves Target Product Profiles (TPPs), Target Product Claims (TPCs) and other TALT documentation for the TA product portfolio. Leads TA-related regulatory due diligences/divestitures. 8. Implement and maintain global regulatory processes and operations for GPS, including GRAST operations. Implement/utilize electronic systems in line with GRA Operational Excellence. 9. If 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. 10. Lives and advocates with team members CSL Leadership Principles, including:
Driving Performance, Building Productive Teams, Developing People and Creating the Future. EDUCATION A bachelor degree (equivalent to a 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. EXPERIENCE Minimum of 15 years' experience in the biotech or pharmaceutical industry, with at least 10 years in Regulatory Affairs and direct experience with clinically regulatory regulatory activities. Experience in leading and managing teams (Minimum 7 years), setting clear direction, holding people accountable and fostering a collaborative team environment within a matrix workplace. 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) Extensive experience interfacing with regulatory agencies and proven skill at developing and implementing successful global regulatory strategies
Salary Range:
$250K -- $500K+
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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