Leader–US Regulatory Affairs-Pharma

Greenfield, Indiana
October 15 2019
Life Sciences
Position Type
Full Time
Organization Type
Job Type
This role has overall accountability for the US Regulatory New Product Development team. The US Regulatory Affairs, Pharmaceutical Director will provide oversight and leadership for the development and execution of global regulatory strategy for pharmaceutical products relating to Safety and Efficacy. Drive delivery of regulatory excellence for innovation projects and support geographic expansion and post approval needs globally. Facilitate development of Elanco's RA skills and effectively coordinate resources to efficiently execute regulatory submissions in collaboration across the Elanco functions; in particular, the regulatory teams, research and development teams, and commercial business units as well as external global regulatory agencies to achieve overall Elanco deliverables and to meet critical registration timelines in compliance with global regulatory standards and guidelines.

Functions, Duties, Tasks:
  • Lead the development and preparation of investigational new animal drug applications, protocols, submissions, supplemental and amended applications, general correspondence and responses to global regulatory agencies.
  • Work in partnership with product development teams, external collaborators and commercial business units to ensure robust data packages, submissions and communications to meet internal and external stakeholder expectations.
  • Lead the review of new product dossiers, identifying gaps and recommend submission strategies to enable timely new product registrations & speed to market
  • Develop, maintain & negotiate directly with Regulatory Agencies and notifiable bodies, including the preparation & review of responses to questions
  • Lead collaboration within the broader Regulatory Affairs function to maintain & acquire Pharmaceutical Marketing Authorisation Applications (MA's)
  • Initiate, seek opportunities for, participate in and lead /contribute to RA transformational initiatives both internally and those shaping the external regulatory landscape.
  • In collaboration with Regulatory & R&D leaders, lead and/or provide input into the regulatory strategy (pre-submission or post approval stages) for both new products; geographic expansion of existing registrations, early development projects and borderline projects
  • Maintain an awareness of the US Regulatory landscape and changing regulatory requirements, specifically for pharmaceutical's
  • Develop global talent to sustain local and global competitiveness. This includes identifying and / or recruiting individuals with leadership & technical leadership potential, providing mentoring and enrichment opportunities consistent with succession planning.
  • Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety and environment (HSE) policies.
  • 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

Company Overview

Elanco is a global animal health company that develops products and knowledge services to prevent and treat disease in food animals and pets in more than 90 countries. With a 64-year heritage, 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. At Elanco, we're driven by our vision of food and companionship enriching life - all to advance the health of animals, people and the planet. Learn more at www.elanco.com

Basic Qualifications

  • Bachelor's degree
  • 5 years exp in regulatory with 2 years in a managerial role
  • Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Additional Information

  • Up to 25% Domestic and International travel required
  • Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

Additional Skills/Preferences

  • Substantial experience in obtaining and maintaining product licenses, ideally within multiple markets & broad knowledge of regulatory filing strategies
  • Substantial knowledge of current drug regulations in key markets (US, EU,)
    Substantial experience of dealing and negotiating directly with Health Authorities in key markets (EU, US)
  • Demonstrated expertise of regulatory lifecycle management processes - dossier preparation, submission and monitoring of post approval commitments.
  • Demonstrated knowledge and experience of the businesses supported including science, product lines, markets served, business strategies and business processes
  • Demonstrated leadership skills, within a global matrix environment
  • Experienced in interpreting regulations and policies, and responding to associated questions.with an emphasis on new molecule registrations
  • Skilled in risk-assessment methodologies, and project organization.
  • Ability to handle multiple tasks and appropriately manage priorities for self and organization
  • 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.
  • Demonstrated ability to effectively communicate and collaborate across a matrix environment
  • Fluent (written & verbal) in English
  • Additional language skills would be highly valued - but not essential
  • Desired, Masters or PhD in Physical, Chemical, or Life Sciences or Management
  • GxP knowledge and experience, would be highly valued

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