Senior Director, Regulatory, CV and Metabolic, TA Lead

CSL Behring in King of Prussia, PA

  • Type: Full Time
position filled
The Senior Director, Regulatory Therapeutic Area Lead is a member of the GRA GPS Leadership Team and contributes to the vision and goals for Global Regulatory Affairs (GRA) by: Providing innovative scientific and regulatory vision, leadership and oversight in defining aligned global regulatory strategies for CSL Behring’s developmental portfolio and core regulatory support for products without ongoing clinical development and accountable for clinical and safety content globally of CSL Behring regulatory documentation for an assigned therapeutic area. Leading and responsible for the activities in a GRA therapeutic area globally and overseeing 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 therapeutic area stakeholders, such a 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 therapeutic areas. Lead the GRA Therapeutic Area Team with a focus on collaboration and decision making for the therapeutic area with GRA functional TA & Site Leads, as appropriate. Represents the GRA Therapeutic Area as a core member of the R&D-wide Therapeutic Area Leadership Team. MAIN RESPONSIBILITIES / ACCOUNTABILITIES Work closely with the Head, GRA GPS to maintain an effective, globally minded, Global Regulatory Affairs organization that is focused on utilizing creative problem solving skills, can clearly articulate the science and regulatory perspective to stakeholders, regardless of level and supports effective GRAST teams for assigned therapeutic area. Contributes to the GRA GPS Leadership Team (GPS LT), appropriately engages GRA Strategy Management Review Team (SMRT) and represents GRA as a core member of the PLG. Accountable to provide innovative scientific and regulatory leadership in defining the global regulatory strategy for therapeutic area that enable successful submissions and approvals for an assigned therapeutic area during all phases of clinical development (Phase I--> IV). Ensure understanding and worldwide alignment of the global regulatory strategy amongst the GRA GPS Therapeutic Area staff . Empower and advise the members of GRA GPS therapeutic area to ensure that the project, clinical, CMC and commercial needs for assigned portfolio are met. Additionally, provide strategic and tactical regulatory leadership and guidance for GRLs, Regulatory Scientists/Specialists, as appropriate. Accountable for clinical / safety related content of all submissions and interactions with the FDA, EMA and other Regulatory Agencies for assigned therapeutic area, 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 GRALT. Ensures all team members have been trained on their role. Responsible to lead GRA Therapeutic Area team to assure delivery of innovative and competitive solutions to accelerate program development, prioritize activities, drive decision making, reduce risks and increase success rate for therapeutic area activities. Collaborates with partner GRA Therapeutic Area / Site Leads and represents GRA at respective governance for assigned therapeutic area. Implement and maintain global regulatory processes and operations for GPS, including GRAST operations. Implement/utilize electronic systems in line with GRA Operational Excellence. When acting as a GRL in limited situations, serve as the Primary Regulatory Interface on the Core Project Team (CPT), Clinical Development Team (CDT) and Safety Management Team (SMT) for GRA, advocate and drive the ‘one GRA’ perspective with team stakeholders. Accountable for scientific clinical / safety related regulatory submission content globally for assigned products. Focuses on team leadership by Driving Performance, Building Productive Teams, Developing People and Creating the Future. On behalf of GRA, reviews and approves Target Product Profiles (TPPs) and Target Product Claims (TPCs) for the Therapeutic Area product portofolio. QUALIFICATIONS / EXPERIENCE Education: A bachelor 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 is preferred (MS, PhD or MD, DVM). Ideal candidates will have a strong clinical foundation. Experience: Minimum of 15 years’ experience in the biotech or pharmaceutical industry, with at least 8 years (prefer 10 years) in Regulatory Affairs Experience in leading and managing teams (Minimum 5 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. Competencies: Strong ethics and integrity Think strategically and develop innovative global strategies Leadership ability with demonstrated problem solving and decision making skills Strong team player with the communication and organizational skills to interact seamlessly both internally and externally on strategic, operational and scientific matters. Effective communication skills, specifically to related complex concepts to a variety of audiences. Ability to develop constructive and effective relationships with direct reports, colleagues and senior management. Proven ability to build and lead effective, well integrated, collaborative teams, empowers others. Cross cultural sensitivity demonstrating understanding and acceptance of different cultural parameters Fluency in English (verbal and written) CSL is introducing a new Career Framework, which will provide a common, global infrastructure for managing jobs and serve as a foundation for future career development and competitive rewards. Certain components of this job description, including Title and Level are subject to change relative to applicable local laws. Your Talent Acquisition Consultant will discuss the pending changes with you. Worker Type:Employee Worker Sub Type:Regular

You may be interested in these similar jobs!
Senior Pharmacometrician/Associate Director Pharmacometrics
CSL Behring in King of Prussia, PA

With operations in 35+ nations and ~ 20,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat …

Read More
Associate Director, TA Lead, Medical Writing
CSL Behring in King of Prussia, PA

With operations in 35+ nations and ~ 20,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat …

Read More
Physician: Hospitalist Regional Medical Director in New Jersey Close to Philadelphia | JOB-2611920
CompHealth in Voorhees, NJ

An exciting regional hospitalist director opportunity is now available in New Jersey. This is a prestigious position over a large program and academi…

Read More
Senior Director, Regulatory Therapeutic Area Lead
Shepherd Regulatory Search in Philadelphia, PA

We have a newly created opportunity for a Senior Director Therapeutic Area Lead that will oversee a global team of GRLs and will be one of five decis…

Read More
Director, CV Epanova Marketing
AstraZeneca in Wilmington, DE

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the im…

Read More
Director, Medical Safety Officer - Immunology
Johnson & Johnson in Horsham, PA

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Director, Medical Safety Officer. A…

Read More
Senior Director, Product Development Clinical Lead
Johnson & Johnson in Spring House, PA

The Senior Director, Product Development Clinical Leader (PDCL) role is responsible and accountable for the oversight of the Scientific and Clinical …

Read More
Director, Senior Global Feasibility Lead
Johnson & Johnson in Spring House, PA

Janssen Research & Development, LLC, a member of Johnson& Johnson's Family of Companies, is recruiting for a Director, SeniorGlobal Feasibility Lead.…

Read More
Senior Scientist – Clinical Pharmacology Oncology TA
Johnson & Johnson in Spring House, PA

Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Scientist, (Oncology TA) Clinica…

Read More
Senior Director Medical Affairs Cardiovascular & Metabolism
CSL Behring in King Of Prussia, PA

About CSLWith operations in 35+ nations and ~ 22,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies …

Read More
Director Medical Education & Communications, Cardiovascular & Metabolic TA
CSL Behring in King Of Prussia, PA

About CSLWith operations in 35+ nations and ~ 22,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies …

Read More
Senior Director, Regulatory TA Lead
CSL Behring in King of Prussia, PA

With operations in 35+ nations and ~ 20,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat…

Read More
Senior Director Medical Affairs Cardiovascular & Metabolism
CSL Behring in King of Prussia, PA

About CSLWith operations in 35+ nations and ~ 22,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies …

Read More
Executive Director
Sunrise Senior Living in Philadelphia, PA

Overview"Sunrise is the best place that I've ever worked, simply because of the people. We provide quality care in an environment that feels like hom…

Read More
Associate Director, Portfolio Resource and Capacity Management Lead, R&D Portfolio Operations
CSL Behring in King of Prussia, PA

With operations in 35+ nations and ~ 20,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat …

Read More