• Job Description

  Req#: JR00016335

  ROLE DESCRIPTION:

  • Coordinate activities, define timing, and create registration files to support new product registrations as well as license maintenance of approved biologicals, pharmaceuticals, bio-pharmaceuticals, Medical Devices and IVD’s or other regulated products in India and BNS 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 and other partner groups to support regulatory strategies and action plans for the registration and introduction of new biologicals and pharmaceuticals in India and BNS market.
  • Provide guidance on VMRD processes and Zoetis policies.
  • Hands on experience on Govt Portal like SUGAM and NANDI and Zoetis Portal like ETS, Veeva Vault and SAP
  • Plan, prepare, coordinate, and execute clinical studies in large or small animals to support registration of Zoetis products when needed.
  • Proactive co-ordination with commercial BU heads and Supply chain for the Post approval changes having impact on product supply.
  • Country Specific Artwork Development and Revision of Existing Artwork

  ORGANIZATIONAL RELATIONSHIPS

  • VMRD
  • Regulatory Affairs (Reg CMC, VMRA, Pharmacovigilance)
  • Artwork Center
  • 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

  QUALIFICATIONS:

  • B.V.Sc / B.Pharm/ M. Pharm
  • 3-4 Years

  KEY COMPETENCIES

  • Analytical Thinking
  • Confidence and Commitment
  • Customer Service
  • Impact and Influence
  • Interpersonal Sensitivity
  • Planning & Prioritizing

  SPECIAL SKILLS & KNOWLEDGE:

  • In depth knowledge of Veterinary Science
  • Multi-disciplinary technical knowledge
  • Knowledge of manufacturing quality systems and processes
  • Knowledge of regulatory laws and guidelines
  • Knowledge of Import / Export regulations and registration/ regulatory procedures in neighboring countries as well as overseas markets
  • General knowledge of regulatory affairs worldwide
  • 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.

  Full time

• About the company

  Zoetis Inc. is the world's largest producer of medicine and vaccinations for pets and livestock.

Notice