Zoetis is a global animal health company dedicated to supporting customers and their businesses. Building on more than 60 years of experience, we deliver quality medicines, biopharmaceuticals and vaccines, complemented by diagnostic products and genetic tests and supported by a range of services. We are working every day to better understand and address the real-world challenges faced by those who raise and care for animals in ways they find truly relevant.
Post : Lead - Regulatory Affairs (13032024)
Job Description
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
Candidate Profile
• M.Sc / M.Pharm
• 5 Years + and team management experience
• 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.
Additional Information
Experience : 5+ years
Qualification : M.Pharm / M.Sc
Location : Mumbai Suburban
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th March 2024
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