Senior Director Regulatory Group Lead

1 week ago

Waltham, United States CSL Full time

CSL 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. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions

Could you be our next Senior Director, Regulatory Lead-Enabling Healthcare Technologies? The job is located in the King of Prussia PA Waltham, MA, Bern Switzerland or Marburg Germany. This is a hybrid position. 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. You will evaluate and bring portfolio strategy to ensure new information is incorporated including regulatory.

You will guide strategic leadership of EHT by building scientific and regulatory visions and in defining aligned EHT (device/combination; digital/connected health; diagnostic; other) strategies that are scientifically rigorous and patient-centered. Promoting the successful advancement of CSL's developmental portfolio, from early-stage development through registration and post-marketing lifecycle management, while integrating and calculated risk-taking to increase impact. Ensuring understanding of organizational goals, encouraging innovation, and delivering meaningful outcomes for patients and your team.

Serving as someone and strategic partner (internal and external), representing GRA on EHT-related governance teams. Leading the GRA EHT Team to ensure seamless collaboration, strategic agreement, and informed decision-making that guides the success of the therapeutic area's portfolio and advances organizational priorities

Cultivate and strengthen strategic relationships with members of the GRA functions and partners in global primary packing and medical devices (PPMD), product development (BPD/PPD), clinical pharmacology and pharmacometrics, clinical development, commercial strategy, safety, project management, quality and TALTs. Ensure seamless collaboration and agreement, with EHT as an important part, to lead the success of therapeutic area programs and organizational goals and execution of device regulatory deliverables/submissions/licenses, globally.

RESPONSIBILITIES:

  • Provide strategic leadership to the EHT Team, encouraging, two-way communication with the GRA Teams (e.g., GRAST/TAST) and main TA partners, including but, not limited to TA Leads and Global Regulatory Leads (GRLs).

  • Collaborate with manager and as an important member of the GRA GPS Leadership Team (GPS LT), serving as a delegate to relevant EHT-related governance bodies and external partnership. Represent us as EHT expert at main regulatory agency meetings, regulatory advisory committee meetings, and other scientific conferences or equivalents.

  • Guide and mentors direct reports to foster thinking and strategic risk-taking in the development of regulatory strategies. Promote the team's growth in expressing project science through a regulatory perspective applying advanced technologies such as informatics, to accelerate the delivery of new therapies and technologies to patients.

  • In specific instances when serving as a Global Regulatory Lead (GRL) - EHT, acts as the primary regulatory interface for the GRAST, and supports GRL in relevant strategy/delivery teams (e.g., Product Strategy Team (PST), Clinical Development Team (CDT), Safety Management Team (SMT), Device Delivery Team, and Commercial Development.

  • Lead regulatory device due diligence and divestiture activities for the therapeutic area, ensuring strategic agreement and compliance throughout the process.

  • In specific instances when serving as a Global Regulatory Lead (GRL), acts as the primary regulatory interface for the Product Strategy Team (PST), Clinical Development Team (CDT), and within Global Regulatory Affairs (GRA).

Experience

  • Bachelor's degree (four-year university degree) in pharmacy, biology, chemistry, pharmacology, clinical medicine, engineering or related life science is required.

  • EHT background including leading a team.

  • 15 years' experience in the biotech or pharmaceutical industry, with at least 10 years in Regulatory Affairs 5 of those years in Medical Device

  • Experience creating and building teams across multiple geographic locations.

  • 7+ years coordinating efforts across diverse teams while maintaining a unified vision.in

  • Focus on developing talent, ensuring the team is and positioned for long-term success in driving organizational goals.

  • Knowledge of pharmaceutical/biological product development and regulatory requirements for product development and approval in more than one main region (EU, US, Japan)

  • Experience in Regulatory Affairs in a global environment across two or more geographic areas

BENEFITS

  • Medical, Dental Vision

  • 401K

  • Paid time Off

#LI-Hybrid

Our Benefits

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what's available to you as a CSL employee.

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.

We want CSL to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL BehringPDN-9db4316e-ef52-4607-a2db-c24075008b10

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