Head of Regulatory Insights and Policy

il y a 4 semaines

Les Ulis, Île-de-France Ipsen Innovation (SAS) Temps plein

Job Title: Head of Regulatory Insights and Policy

Division / Function: Global Regulatory Affairs (GRA)

Manager (Job Title): Vice President, Head of GRA Excellence

Location: Global

Summary / Purpose of the Position

The Head of Regulatory Insights and Policy will be responsible for overseeing and managing the regulatory surveillance, impact evaluation, and dissemination of critical intelligence from regulatory bodies pertinent to Ipsen's interests. This role will facilitate and conduct necessary regulatory research to inform therapeutic area strategies, leveraging expertise to guide strategic decision-making by GRA Leadership and the Global Regulatory Leadership team. Additionally, this position will support regulatory policy initiatives, ensuring internal alignment on priority advocacy topics and representing Leadership in external discussions, including trade associations globally. This role is pivotal for establishing a strong Global Regulatory Affairs team and requires an Enterprise leader with a well-established external regulatory network.

Regulatory Insights Management

Oversee all activities related to the enhancement and maintenance of Ipsen's regulatory insights framework for the Global Regulatory Affairs team, including but not limited to:

  • Conducting daily monitoring of key regulatory sources based on specified areas of interest (such as therapeutic areas and regulatory jurisdictions).
  • Collaborating with internal departments to ensure effective impact assessments are conducted.
  • Consulting and sharing relevant local regulatory insights with the Local Regulatory Affairs community.
  • Communicating actionable intelligence effectively across the Enterprise.
  • Managing external vendors and systems that facilitate regulatory insights deliverables.
  • Ensuring a comprehensive knowledge management system within GRA.

Regulatory Research and Analysis

Gather and analyze regulatory inquiries from GRA sub-teams and other internal stakeholders, conducting necessary regulatory research in areas including but not limited to:

  • Regulatory precedents related to the competitive landscape of the portfolio and pipeline.
  • Analysis of regulatory requirements affecting topics of interest in various countries/regions.
  • Horizon scanning and identification of trends in key regulatory science areas.

Regulatory Policy Support

Facilitate internal coordination and alignment of GRA's stance on priority areas for external scientific and regulatory advocacy, including but not limited to:

  • Coordinating responses to public consultations from regulatory authorities on key topics for Ipsen.
  • Supporting GRA Leadership's engagement in relevant trade associations.
  • Collaborating with internal teams to drive specific initiatives with significant external components requiring regulatory expertise (e.g., public-private partnerships).
  • Promoting external engagement in learned societies and regulatory/scientific associations.

Additional Responsibilities

  • Advising the GRA Leadership Team on significant risks and opportunities presented by the external regulatory landscape affecting our business, pipeline, and portfolio.
  • Partnering with internal stakeholders such as Corporate and Global Public Affairs to advance Ipsen's external priorities.
  • Supervising staff involved in regulatory insights and policy tasks as part of their professional development.
  • Overseeing and managing relevant Quality processes for the implementation of regulatory insights within GRA, collaborating with pertinent functions to ensure comprehensive surveillance of the external environment.
  • Supporting Quality initiatives concerning regulatory insights and requirements as part of Ipsen's GxP Quality system.

Knowledge, Abilities & Experience

Education / Certifications:

  • Advanced degree (MSc, PhD) in a relevant field is required.
  • A degree in Life Sciences is preferred.
  • Proven ongoing education in regulatory training and development.

Experience:

  • Over 10 years of experience in the pharmaceutical industry and/or a health authority, with a proven track record in regulatory analysis, intelligence, or asset strategies.
  • Experience with multiple regulatory jurisdictions and a strong understanding of key reference countries (i.e., EU, US, JP, CN) and global regulatory topics (e.g., ICH).
  • Comprehensive knowledge of primary regulatory areas, including but not limited to Regulatory Strategy, CMC, Labeling, Operations, Process, and Compliance.
  • Extensive experience in conducting regulatory research across various domains, demonstrating how insights and analytics have informed regulatory decision-making.
  • Proven ability to manage regulatory insights deliverables in medium to large organizations.
  • Previous experience leading internal and/or external cross-functional initiatives involving a broad range of stakeholders.
  • Experience in driving external representation through trade associations and public commentary is advantageous.
  • People management experience is a plus but not mandatory.

Competencies:

  • Exceptional interpersonal and communication skills, with a demonstrated ability to interact with and influence a diverse range of individuals.
  • Proficient in building relationships both internally and externally.
  • Strong attention to detail and analytical mindset.
  • Effective communicator, open to dialogue and skilled in diplomacy.
  • Ability to maintain a holistic view and connect various elements in a complex environment.
  • Capable of representing the company professionally.
  • Proactive with a positive attitude in all situations.
  • Flexible, independent problem solver with self-direction.
  • Eager to learn and develop personally and support the growth of others.
  • Ability to work effectively in a hybrid (office and remote) setting.
  • Willingness to travel for professional responsibilities (less than 20% expected).
  • Proficient in MS Office and familiar with essential IT tools.

Languages:

  • Proficiency in English is mandatory.
  • Proficiency in French is preferred but not required.

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