Main Responsibilities and Accountabilities:
1. Support the Global Lead RI & P in developing the Global Regulatory Intelligence and Policy function.
2. Gather, analyze, and timely communicate relevant North American regulatory information in concurrence with the global RI & P strategy.
3. Monitor and assess the NA regulatory environment, as assigned, to anticipate and communicate regulatory trends through an understanding of regulatory guidelines, regulations, and laws that may have an impact on CSLB’s products and regulatory business processes.
4. Facilitate the process for assessing draft NA regulations and regulatory guidelines, their potential impacts on CSLB’s products, commenting them to recommend the development of CSLB’s specific position; propose and align on an action plan with the Global Lead RI & P.
5. Contribute to and inform a Global Regulatory Intelligence strategy aiming at delivering regular RI updates by providing education, knowledge sharing, newsletters, reports and other modes of communication to advance regulatory expertise and decision making. Effectively communicate (verbally, written) on assigned regulatory intelligence topics to a diverse audience.
6. Work with external parties/consultants as appropriate to support the Regulatory Intelligence process (access to sources of information, data gathering, analysis and dissemination).
7. Collaborate with NA regulatory functions, CSLB’s Policy department, and other functions as appropriate to stay abreast of changes in the NA regulatory environment. The objective is to provide context and broader perspective but also to identify and prioritize NA topics for surveillance.
8. Engage with external NA Key Opinion Leaders and represent RI & P on external forums / networks and NA Trade Associations as assigned; thereby, positively influence the NA regulatory environment to meet business needs. Provide comprehensive summaries and strategic advice back to the Global Lead RI & P to formulate and shape globally aligned policies and positions on regulatory topics.
9. Represent RI & P on internal forums or working groups, as assigned.
10. Interact with NA regulatory Health Authorities on general and non-product related topics. This activity is conducted in partnership with the Head GRA Region North America.
- A degree in life sciences (at least BSc) or Medical Science or Pharmacy, preferably with a post-graduate qualification. Degree e.g. in Drug Regulatory Affairs advantageous
- Minimum of 6 years of life science experience
- Regulatory experience or a solid combination of regulatory and/or related experience in both development and post-marketing phases
- Knowledge and understanding of the NA regulatory environment
- Previous experience in delivering regulatory policy and intelligence is an advantage
- Superior communication and presentation skills in English, both verbal and written
- "Big picture thinker" with strong business perspective
- Ability to influence and develop a network
- Ability to work in a team, high customer focus, and innovative thinking
- Embraces change and should possess the ability to effectively work in an international, multicultural and matrix environment
- Business travels will be required (up to 20% of the time)
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Equal Opportunity Employer
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