Head of RA Business Operations
Il y a 14 heures
Lyon, Auvergne-Rhône-Alpes, France
Boehringer Ingelheim
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Developing innovative treatments for Human and Animal Health has been the commitment of Boehringer Ingelheim for more than 130 years. Boehringer Ingelheim is a family-owned company dedicated to research and development and ranks among the world’s top 20 pharmaceutical companies. Every day, our employees create value through innovation in the fields of Human Health, Animal Health, and contract biopharmaceutical manufacturing.
Boehringer Ingelheim Animal Health France is committed to improving animal health. With more than 10,000 employees worldwide, Boehringer Ingelheim’s Animal Health business offers products in more than 150 markets and has a presence in 99 countries.
At Boehringer Ingelheim Animal Health, we are looking for an experienced and influential Head of Regulatory Affairs Business Operations to lead global regulatory operations and play a key role in shaping the external regulatory environment.
This highly visible leadership position offers a unique opportunity to drive regulatory excellence, influence international policy discussions, and support the development and commercialization of innovative animal health solutions worldwide.
As a member of the Regulatory Affairs leadership team, you will work at the intersection of strategy, operational excellence, stakeholder engagement, and people leadership.
Your Impact
Drive Global Regulatory Operations Excellence
You will lead the global regulatory operations function, ensuring efficient and compliant management of regulatory submissions, publishing activities, regulatory systems, and operational processes.
Key responsibilities
include:
• Leading global regulatory operations and governance activities.
• Driving continuous improvement across systems, tools, and processes.
• Ensuring inspection readiness, compliance, and operational excellence.
• Overseeing outsourced regulatory operations activities and strategic partnerships.
• Supporting the delivery of a robust and future-oriented regulatory infrastructure. Influence the Global Regulatory Environment You will represent the company externally and build trusted relationships with key regulatory stakeholders. You will:
• Engage with international regulatory authorities and industry associations.
• Represent the organization in regulatory policy discussions and working groups.
• Contribute to the development of future regulatory frameworks impacting animal health.
• Advocate for science-based and business-oriented regulatory approaches.
• Serve as a recognized regulatory leader within the global industry community. Act as a Strategic Business Partner Working closely with cross-functional stakeholders, you will help shape business decisions that support innovation and growth. You will:
• Provide strategic regulatory guidance to senior leaders.
• Partner with R&D, Pharmacovigilance, Manufacturing, Quality, Supply Chain, and Commercial teams.
• Support product development, market expansion, and lifecycle management initiatives.
• Anticipate regulatory trends and assess their impact on business strategy. Lead and Develop High-Performing Teams You will inspire and develop an international team of regulatory professionals while fostering a culture of collaboration, accountability, and innovation. You will:
• Lead diverse, multicultural teams across regions.
• Coach and develop future leaders.
• Foster engagement, inclusion, and continuous learning.
• Drive organizational transformation and change initiatives. What You'll Bring Education
• Doctorate or advanced degree in Veterinary Medicine or Pharmacy.
• Additional scientific qualifications in Life Sciences are considered an advantage. Mandatory Experience and Qualifications
• More than 10 years of experience in Global Regulatory Affairs within the Animal Health industry.
• More than 15 years of leadership experience managing Regulatory Affairs teams in a global and multicultural environment, including geographically dispersed teams.
• Demonstrated experience leading Regulatory Operations functions including regulatory data, document management and submission systems.
• Proven experience representing an Animal Health company with international regulatory bodies, industry associations and key health authorities.
• Demonstrated experience in regulatory advocacy, policy development and stakeholder engagement within Animal Health.
• Proven experience managing outsourced Regulatory Affairs and/or Pharmacovigilance activities on a global scale.
• Deep and current knowledge of international Animal Health regulatory requirements across multiple product modalities.
• Proven track record in organizational transformation, change management and building high-performing Regulatory Affairs organizations.
• Fluency in English. Preferred Qualifications
• Previous representation of the company within international industry organizations such as VICH and/or Health for Animals (HfA).
• Experience operating at Regulatory Affairs Leadership Team (RALT) level or equivalent executive leadership forums.
• Experience across multiple Animal Health companies.
• Strong knowledge of regulatory publishing activities and submission technologies.
• Deep understanding of regulatory master data, product definitions and associated governance processes.
• Experience leveraging Artificial Intelligence and digital technologies to improve Regulatory Affairs efficiency and effectiveness.
• Fluency in German, French and/or Spanish. Working conditions
• Compensation paid over 14 months, with profit-sharing and incentive schemes.
•
Working hours
Executive status (annual days-based working time arrangement / forfait jours).
• RTT days (working time reduction days) + 31 days of paid leave, prorated according to time worked.
• Other
benefits:
company restaurant and Works Council (CSE). Boehringer Ingelheim promotes diversity and is committed to the inclusion and support of people with disabilities.
Key responsibilities
include:
• Leading global regulatory operations and governance activities.
• Driving continuous improvement across systems, tools, and processes.
• Ensuring inspection readiness, compliance, and operational excellence.
• Overseeing outsourced regulatory operations activities and strategic partnerships.
• Supporting the delivery of a robust and future-oriented regulatory infrastructure. Influence the Global Regulatory Environment You will represent the company externally and build trusted relationships with key regulatory stakeholders. You will:
• Engage with international regulatory authorities and industry associations.
• Represent the organization in regulatory policy discussions and working groups.
• Contribute to the development of future regulatory frameworks impacting animal health.
• Advocate for science-based and business-oriented regulatory approaches.
• Serve as a recognized regulatory leader within the global industry community. Act as a Strategic Business Partner Working closely with cross-functional stakeholders, you will help shape business decisions that support innovation and growth. You will:
• Provide strategic regulatory guidance to senior leaders.
• Partner with R&D, Pharmacovigilance, Manufacturing, Quality, Supply Chain, and Commercial teams.
• Support product development, market expansion, and lifecycle management initiatives.
• Anticipate regulatory trends and assess their impact on business strategy. Lead and Develop High-Performing Teams You will inspire and develop an international team of regulatory professionals while fostering a culture of collaboration, accountability, and innovation. You will:
• Lead diverse, multicultural teams across regions.
• Coach and develop future leaders.
• Foster engagement, inclusion, and continuous learning.
• Drive organizational transformation and change initiatives. What You'll Bring Education
• Doctorate or advanced degree in Veterinary Medicine or Pharmacy.
• Additional scientific qualifications in Life Sciences are considered an advantage. Mandatory Experience and Qualifications
• More than 10 years of experience in Global Regulatory Affairs within the Animal Health industry.
• More than 15 years of leadership experience managing Regulatory Affairs teams in a global and multicultural environment, including geographically dispersed teams.
• Demonstrated experience leading Regulatory Operations functions including regulatory data, document management and submission systems.
• Proven experience representing an Animal Health company with international regulatory bodies, industry associations and key health authorities.
• Demonstrated experience in regulatory advocacy, policy development and stakeholder engagement within Animal Health.
• Proven experience managing outsourced Regulatory Affairs and/or Pharmacovigilance activities on a global scale.
• Deep and current knowledge of international Animal Health regulatory requirements across multiple product modalities.
• Proven track record in organizational transformation, change management and building high-performing Regulatory Affairs organizations.
• Fluency in English. Preferred Qualifications
• Previous representation of the company within international industry organizations such as VICH and/or Health for Animals (HfA).
• Experience operating at Regulatory Affairs Leadership Team (RALT) level or equivalent executive leadership forums.
• Experience across multiple Animal Health companies.
• Strong knowledge of regulatory publishing activities and submission technologies.
• Deep understanding of regulatory master data, product definitions and associated governance processes.
• Experience leveraging Artificial Intelligence and digital technologies to improve Regulatory Affairs efficiency and effectiveness.
• Fluency in German, French and/or Spanish. Working conditions
• Compensation paid over 14 months, with profit-sharing and incentive schemes.
•
Working hours
Executive status (annual days-based working time arrangement / forfait jours).
• RTT days (working time reduction days) + 31 days of paid leave, prorated according to time worked.
• Other
benefits:
company restaurant and Works Council (CSE). Boehringer Ingelheim promotes diversity and is committed to the inclusion and support of people with disabilities.