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Principal Consultant, Global Regulatory Affairs Biologicals Innovation

48050
Principal Consultant, Global Regulatory Affairs Biologicals Innovation
Flexible; Basel, Antwerp, Madrid, Paris, Bad Homburg, Cuxhaven or Basingstoke office
Flanders, Basel Stadt, Lower Saxony, Hesse, Madrid, Hauts-de-Seine, Hampshire
Belgium, Switzerland, Germany, Spain, France, United Kingdom
Europe; Middle East; Africa
Regional
Elanco Animal Health is a global animal health company that develops products and knowledge services to prevent and treat diseases in food animals and pets in more than 90 countries. Founded in 1954, we rigorously innovate to improve the health of animals and benefit our customers, while fostering an inclusive, cause-driven culture for more than 5,800 employees.
Position Description:
This role provides global strategic regulatory oversight and is assigned regulatory accountability on complex individual antigens or combination of antigens and innovative platforms in development until licensure. This is accomplished through expert knowledge and understanding of regulations, guidelines, regulatory precedence and the evolving regulatory framework to expedite the development and delivery of safe and effective products for animals. To accomplish this purpose, it is necessary for the Principal Consultant to maintain and extend relationships across Elanco components, regulatory agencies, partner companies, industry groups, and academia.

Key Technical Responsibilities:
  • Thorough knowledge of vaccine science, regulations and guidelines of biologicals licensure on a global scale.
  • Recognized vaccine expert in the company
  • Anticipate and resolve key regulatory problems of global vaccine developments
  • Coordinate and/or conduct the preparation of new biological applications, responses to questions posed by regulatory agencies
  • Author and/or review of appropriate policies, SOPs, and guidance as needed.
  • Maintain a positive business relationship with regulatory authorities.
  • Ensure that biologicals regulations are met
  • Align with global, regional and affiliate Regulatory employees to make sure local regulations are met
Key Leadership Responsibilities:
  • Provide leadership of the development and execution of regulatory strategy
  • Work effectively and flexible within all related Elanco disciplines and external collaborators to achieve overall Elanco RA deliverables
  • Deliver scientifically sound high quality and approvable product submissions
  • Provide and accept challenge to deliver innovative scientific and regulatory solutions and create innovative culture
  • Create an engaging culture with “Play to win” mentality
  • Manage project timeline and budget deliverables to facilitate delivery and maintenance of the Elanco pipeline.
  • Develop regulatory talent to sustain local and global competitiveness. This includes identifying individuals with leadership potential, providing mentoring and enrichment opportunities consistent with succession planning.
  • Any other duties or projects as requested by the Line Manager commensurate with the grade and level of responsibility for this role, for which the employee has the necessary experience and/or training
  • Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety and environment (HSE) policies.
48050BR
Bachelor Degree in the Biological Sciences or higher

Language:
Fluency (verbal / written) in English is essential, additional European language skills highly desirable.
  • Demonstrated experience / expertise in research and development as well as licensure of biologicals internationally.
  • Demonstrated experience in European Licensing Procedures for Immunological/Biological Veterinary Medicinal Products.
  • Demonstrated leadership experience within in matrix environment, including experience leading multi-cultural teams and influencing senior technical and business leaders
  • Effective interpersonal and communication skills, must understand how to influence and diplomatically challenge when needed.
  • Demonstrated ability to initiate and drive change across sites; projects & the wider organization.
  • Strong understanding of risk assessment and risk management fundamentals/tools
  • Experienced interpreting regulations and policies, and responding to associated questions.
  • Able to define problems, collect and review data, establish facts and draw valid conclusions.
  • Ability to evaluate metrics and trend data to drive robust continuous improvement plans.
  • Location: either Basel (Switzerland), Antwerp (Belgium), Alcobendas, Madrid (Spain), Neuilly sur Seine, Paris (France), Bad Homburg or Cuxhaven (Germany) or Basingstoke (UK)
  • Expected travel: up to 25%
  • Reports to: Sr. Director Global Regulatory Affairs Biologicals