Director Global Regulatory Science, Policy, and - Bern, Schweiz - CSL Behring

CSL Behring

Geprüftes Unternehmen

Bern, Schweiz

vor 1 Woche

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

This role's primary responsibility is to advance the regulatory science and policy field, to monitor, anticipate and provide strategic analyses of t; he European regulatory environment, and to actively participate in the shaping of the regulatory science and policy field in collaboration and alignment with the Head of Global Regulatory Science & Policy and the global regulatory function internally (e

g:
forming CLS positions) and externally (e.g., ensuring CLS visibility and influence).

The incumbent will keep the organization abreast of changes, trends, and developments of the regulatory environment, inform decision making and provide CSL with a competitive advantage.

Role responsibilities

Contribute to the advancement of Europe regulatory science and policy and shaping the global regulatory environment by identifying and coordinating nonproduct specific opportunities to interact and/or collaborate with health authorities in Europe.
Work within the GRA team to create and implement strategic plan for external stakeholder engagement for each key regulatory policy roadmap objective.
Represent CSLB in multistakeholder forums including but not limited to: trade associations committees, think tanks, patient advocacy organizations, professional associations, international congresses, and other highvalue opportunities for scientific and regulatory exchange, and ensure such opportunities are maximized by productive and concrete engagement
Participate in internal efforts to create strategies that advance CSL business and regulatory science & policy objectives across European region.
Assist in preparing for meetings and interactions with health authorities to discuss regulatory science topics.
Gather, analyze, assess, and timely communicate relevant global regulatory information and trends through an understanding of regulatory guidelines, regulations, and laws that may have an impact on CSL'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 advance regulatory expertise and decisionmaking. Effectively communicate (verbally, written) on assigned regulatory intelligence topics to a diverse audience.
Facilitate the process for assessing draft global regulations and regulatory guidelines, and their potential impacts on CSL's products, commenting on them to recommend the development of CSL's specific position, and propose and align on an action plan with the Head of Global Regulatory Science & Policy.
Work with Subject Matter Experts within CSL to understand and prioritize regulatory risks and opportunities and formulate and shape aligned policies and positions on European regulatory topics.
Contribute to the development and maintenance of a Regulatory Policy Roadmap and measurement of efficiencies through impact assessment measures and KPIs.
Collaborate with global regulatory functions, CSL's PAGA function, other Intelligence groups (e.g. Competitive Intelligence) and other functions as appropriate to stay abreast of changes in European regulatory environment. The objective is to provide context and a broader perspective and identify and prioritize global topics for surveillance and advocacy.
Work with external parties/consultants as appropriate to support the Regulatory Intelligence process (access to sources of information, data gathering, analysis, and dissemination).

Background education, past experiences, and skills

A degree in life sciences (at least BSc) or Medical Science or Pharmacy, preferably with a postgraduate 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 postmarketing phases
Knowledge and understanding of European 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)

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, hemato