Role Description
Responsibilities:
This role reports directly into the Regional RA Lead for Africa, Southeast Asia, and South Asia. It spans across 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. This is a critical role for the organization with responsibilities for ongoing business as well as expansion and growth opportunities for Zoetis in this region. The incumbent is expected to support Regional RA Lead to implement consistent global processes with the flexibility to meet local needs and drive the aligned key success measures.
Key Responsibilities
Regulatory Compliance:
• Maintain up-to-date regulatory knowledge and drive the regulatory strategy to support the registration, import and sale of products.
• 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.
• Drive all local affiliate quality related workstreams in collaboration with regional and global quality teams
• Act as primary interface with other functions at the operating level; direct interface with all business functions on technical aspects of regulatory affairs.
• Promote and inform the development and substantiation of creative claims that enable the business to maximise the competitive advantage within compliance scope.
• Contribute to the development and implementation of, and adherence to robust business processes that ensure products and claims are legally compliant.
• Provide reasoned and analytical risk assessments as required that evaluate regulatory risk, business exposure and likely consequences, as well as providing opportunities for mitigation.
• Provide regulatory advice and guida