This position is no longer open for applications

Responsibilities:

This role reports directly into the General Manager of India and the Distributer Markets of Bangladesh, Nepal and Sri Lanka (BNS).  The incumbent will be a part of the Leadership Team (LT) and have 2 direct reports. The team led by the regulatory lead will look after all regulatory and local affiliate quality related responsibilities in India and BNS.

• Coordinate activities, define timing, and create registration files to support new product registrations as well as maintenance of approved biologicals, pharmaceuticals, or other regulated products in India and BNS.
• Set registration timelines and milestones, and communicate to local team as well as global cross-functional units
• As the regulatory member on product development teams and commercial strategy teams, provide strategic, proactive, and timely regulatory expertise specific to the planning, requirements, and execution of projects.
• Provide regulatory advice and guidance to the commercial, technical and cross functional teams to ensure product submissions and importations meet regulatory requirements
• Liaise, network and collaborate with regulatory bodies and appropriate ministries to support new registration requirements and maintenance of current product portfolio.
• Plan, prepare, coordinate and work with the clinical team to execute studies in large or small animals to support registration of Zoetis products when needed
• Review and verify packaging labels where applicable, revise labels per local regulatory authority requirement for registration and importation
• Develop SOPs and provide regulatory input to product life-cycle planning
• Manage secondary repackaging procedures in line with SOPs and regulatory requirements
• Maintain up-to-date legal and regulatory knowledge on the registration, import and sale of products.
• Look after all local quality related workstreams in collaboration with regional and global quality teams
• Support the engagement of regulators to progress regulatory policy activities in line with local business, regional & global regulatory policy priorities
• Support key projects in the local and/or regional industry associations to collaborate and intensify priorities that facilitate our business and processes. 
• Oversee and develop a team of highly motivated, experienced and dedicated direct reports responsible for regulatory and quality functions

Qualifications (Training, Education & Prior Experience):

• V.Sc / M.Pharm
• 5 Years + and team management experience

Key Competencies

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

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
• General knowledge of regulatory affairs worldwide
• Knowledge of livestock and companion animal diseases, treatment and preventative medicine.
• 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.