Lead Counsel Regulatory, Safety & PhV

CSL•King of Prussia, PA

About The Position

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/. At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

Requirements

Advanced degree in Life Science or Business with a post graduate qualification (PhD, MD, MBA or other).
12+ years' experience in the pharmaceutical industry, at least 8 years' experience in Global Regulatory Affairs; biologics regulatory experience preferred.
10+ years' leadership experience, including managing regulatory teams.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

Nice To Haves

biologics regulatory experience preferred.

Responsibilities

Acts as a leader with government regulator interactions.
Provides development and may lead implementation strategies for timely submission and approval of pre-clinical submissions, applications for clinical trials, marketing applications, etc.
Provides counsel to and manages a regulatory sub-function; ensures timely preparation of organized and scientifically valid applications; provides expertise in translating regulatory requirements into practical, workable plans.
Selects, develops and evaluates personnel to ensure the efficient operation of the function.
Ensures compliance with all regulatory requirements.
Maintains a strong collaborative relationship across the CSL sites; this includes site communications & knowledge sharing; develops and maintains good working relationships with all stakeholders.
Maintains an intimate knowledge of biological regulations.

Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

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