Manager, Regulatory Affairs

 •  Zoetis Kalamazoo, MI

5 - 7 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 07/24/17
Kalamazoo, MI
5 - 7 years experience
Biotech/Pharma
Salary depends on experience
Posted on 07/24/17

JOB DESCRIPTION

The position will support and coordinate registration of veterinary products (biologicals, pharmaceuticals, biopharmaceuticals, MFA’s) in the markets integrating Zoetis’ Canada, Asia and Latin America Region (CALAR). This role will be responsible for leading, coordinating and supporting activities to assure designated veterinary products are developed and licensed in CALAR markets in compliance with Zoetis policies and appropriate regulatory requirements.

POSITION RESPONSIBILITIES

  • Coordinate activities, define timing, and create registration files to support new product registrations as well as maintanence of approved biologicals, pharmaceuticals, bio-pharmacueticals, or other regulated products in CALAR markets.
  • As the CALAR regulatory member on product development teams, provide strategic, proactive, and timely regulatory expertise specific to the planning, requirements, and execution of the project.
  • Liaise with Reg CMC, VMRA, GMS, CDLCI and other partner groups to support the definition of regulatory strategy and action plans for the registration and introduction of new biologicals and pharmaceuticals in CALAR markets.
  • Provide guidance on VMRD processes and Zoetis policies to all iCRAMS located in CALAR markets.
  • Plan, prepare, coordinate and execute clinical studies in large or small animals to support registration of Zoetis products when needed.

ORGANIZATIONAL RELATIONSHIPS

  • VMRD:
    • Regulatory Affairs (Reg CMC, VMRA, Pharmacovigilance)
    • Global Biologics Research
    • Global Therapeutics Research
    • Research Strategy and Portfolio Management
    • Laboratory Sciences
    • Business Technology
    • Diversified R&D
  • International Operations:
    • iCRAMS from CALAR markets
    • Business Unit Managers from CALAR markets
    • Cluster Leads
  • Strategy, Commercial and Business Innovation
  • GMS:
    • Global Quality
    • Global External Supply
    • Global Supply Chain & Logistics
    • Biologics Operations
    • MFA & API Operations
    • Pharma & Aseptics Operations
    • Global Technology
    • Special Operations, BD, Integration, Diagnostics & Poultry

EDUCATION AND EXPERIENCE

  • Degree in Veterinary Medicine (DVM or equivalent professional title) or equivalent degree in Animal Health related field. Advanced degree is desirable.
  • 5 or more years of experience in the Animal Health, Human Health and/or related industries dealing with regulatory issues in particular and related industry matters in general.
  • Experience developing regulatory submissions and interacting with regulatory agencies preferred.
  • Experience planning, coordinating and executing clinical programs/studies for veterinary biologicals and pharmaceuticals preferred.
  • Proficiency in second language preferred (Spanish, Portuguese, Chinese or Japanese).

TECHNICAL SKILLS REQUIREMENTS

  • Knowledge of livestock and companion animal diseases, treatment and preventative medicine.
  • Knowledge of manufacturing process for veterinary biologicals and pharmaceuticals.
  • Knowledge of veterinary biological and pharmaceutical research and development process.
  • Knowledge of international regulatory requirements for registration and export/import of veterinary biologicals and pharmaceuticals.
  • Knowledge of technical writing.
  • Knowledge of study design, protocol preparation, study planning and execution of clinical studies in large and small animals preferred.
  • Strong verbal and written communication skills and a demonstrated ability to work in a team environment.
  • Proven track record or organization skills.

JR00001231

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