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Director, Regulatory Science, Policy & Intelligence- North America Lead

Employer
CSL Behring
Location
Working from home
Start date
Sep 25, 2022

View more

Discipline
Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time
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Job Details

Job Description

Reporting to the Head of Global Regulatory Science, Policy, and Intelligence, your primary responsibility will be to promote the regulatory science field, provide strategic analyses of the North America regulatory environment, and to participate in the shaping of the regulatory science field according to the global regulatory function internally (e.g.: forming CLSB positions) and externally (e.g.: ensuring CSL visibility and influence). You will keep the organization informed about changes, trends, and developments of the regulatory environment, inform decision-making, and provide CSL Behring (CSLB) with a competitive advantage.

Note: This role can be remotely-based within the US Eastern Time Zone.

Responsibilities:

Advance Regulatory Science:

  • Contribute to the advancement of North America regulatory science and shaping the global regulatory environment by identifying and coordinating non-product specific opportunities to work or collaborate with global health authorities
  • Work within the Global Regulatory Affairs (GRA) team to develop strategies for external partner engagement for each necessary regulatory policy roadmap objective
  • Represent CSLB in multi-stakeholder forums including: trade associations committees, think tanks, patient advocacy organizations, professional associations, international congresses, and other high-value opportunities for scientific and regulatory exchange, and ensure such opportunities are maximized by productive and concrete engagement
  • Be the regulatory team's subject-matter-expert in certain forums where CSLB North America policy strategy development efforts are coordinated by Public and Government Affairs (PAGA) team and work with PAGA team and the GRA team to identify and agree on regulatory policy goals and vaccine regulatory policy concepts for both internal and external use
  • Participate in internal efforts to create strategies that promote CSLB business and regulatory science and policy goals across North America region
  • Help prepare for meetings and interactions with health authorities to discuss regulatory science topics.

Gather, analyze, assess, and communicate relevant global regulatory information and trends through an understanding of regulatory guidelines, regulations, and laws that may have an impact on CSLB's products and regulatory business processes.

Contribute to and inform a Global Regulatory Intelligence (RI) strategy aiming at delivering regular RI updates by providing education, knowledge sharing, newsletters, reports and other modes of communication to improve regulatory expertise. Communicate (verbally, written) on assigned regulatory intelligence topics to a diverse audience.

Facilitate the process for assessing draft global regulations and regulatory guidelines, their potential impacts on CSLB's products, commenting them to recommend the development of CSLB's specific position, and propose and agree on an action plan with the Head of Global Regulatory Science & Policy.

Work with Subject Matter Experts within CSLB to prioritize regulatory risks and opportunities and create and shape aligned policies and positions on North America regulatory topics.

Contribute to the development of a Regulatory Policy Roadmap and measurement of efficiencies through impact assessment measures and goals.

Collaborate with global regulatory functions, CSLB's PAGA function, other Intelligence groups (e.g. Competitive Intelligence) and other departments to stay up-to-date with changes in North America regulatory environment. The objective is to provide context and broader perspective but also to identify global topics for surveillance and advocacy.

Work with external parties/consultants to support the Regulatory Intelligence process (access to sources of data gathering, analysis and distribution).

Education/Experience:

  • Bachelor's Degree required with preferred focus in the life sciences or Medical Science or Pharmacy; post-graduate qualification or degree in Regulatory Affairs is advantageous
  • Minimum of 6 years of life science experience
  • Regulatory experience or a solid combination of regulatory and related experience in both development and post-marketing phases
  • Understanding of US regulatory environment
  • Previous experience delivering regulatory policy and intelligence is an advantage
  • Experience working at or with FDA or EMA is desirable

Travel requirements: up to 25%, including 1 week per month to King of Prussia, PA office

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About Us

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

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 organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.

Do work that matters at CSL Behring!

Company

As the third largest global biotechnology company with employees in more than 35 countries, CSL Behring is focused on serving patients with serious and rare diseases, including coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease and neurological disorders. We collaborate with patient and biomedical communities to improve access to therapies, advance scientific knowledge and support future medical research. 


CSL Behring's dynamic environment fosters innovation and attracts the best and brightest who share a commitment to helping save lives. People here are free to live their Promising FUTURES where they can fulfill their individual career aspirations and realize their potential. 


CSL Behring is committed to diversity and inclusion, both of which underpin our Values of patient focus, innovation, collaboration, integrity and superior performance. We believe that by harnessing and honoring the unique capabilities, experiences and perspectives of our people, we are better able to serve our patients.


CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited, headquartered in Melbourne, Australia, employs more than 27,000 people, and provides its life-saving medicines in more than 70 countries. 
For more information visit www.cslbehring.com. Help us deliver on our promise to save lives and protect the health of people around the world. Promising FUTURES start at CSL Behring!

Stock Symbol: CSL

Stock Exchange: Australian Securities Exchange

Find Us
Phone
610-878-4000
Location
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States
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