Senior Director Regulatory Group Lead - Enabling Healthcare Technologies

Detalles de la oferta

Senior Director Regulatory Group Lead - Enabling Healthcare TechnologiesCSL 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.Could you be our next Senior Director, Regulatory Lead-Enabling Healthcare Technologies? This is a hybrid position located in King of Prussia, PA, Waltham, MA, Bern, Switzerland, or Marburg, Germany. You will report to the Executive Director, Global Regulatory TA Head.You will play an important leadership role as part of the Global Regulatory Affairs (GRA) GPS Leadership Team. You will lead the strategic vision and goals for the GRA Enabling Healthcare Technologies Team (EHT), ensuring understanding of organizational goals and advancing innovation and excellence across the R&D therapeutic areas (TA) and portfolio.RESPONSIBILITIES:Provide strategic leadership to the EHT Team, encouraging two-way communication with the GRA Teams and main TA partners.Collaborate with manager and serve as a delegate to relevant EHT-related governance bodies and external partnerships.Guide and mentor direct reports to foster strategic risk-taking in regulatory strategies.Lead regulatory device due diligence and divestiture activities for the therapeutic area.In specific instances, serve as a Global Regulatory Lead (GRL) and act as the primary regulatory interface for relevant teams.Experience:Bachelor's degree in pharmacy, biology, chemistry, pharmacology, clinical medicine, engineering or related life science is required.15 years' experience in the biotech or pharmaceutical industry, with at least 10 years in Regulatory Affairs and 5 years in Medical Device.Experience creating and building teams across multiple geographic locations.Knowledge of pharmaceutical/biological product development and regulatory requirements for product development and approval in more than one main region (EU, US, Japan).BENEFITS:Medical, Dental, Vision401KPaid time OffEqual Opportunity EmployerCSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click here.#J-18808-Ljbffr


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

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