Associate Director – Regulatory Affairs

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 innovative 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 guidance to the commercial, technical and cross functional teams to ensure product submissions and importations meet regulatory requirements.

• Review and verify packaging labels where applicable, revise labels per local regulatory authority requirement for registration and importation.

• Manage secondary repackaging procedures in line with SOPs and regulatory requirements

• Review of promotional materials in collaboration with technical teams to ensure compliance with regulatory requirements.

External Stakeholder Management:

• Liaise, network and collaborate with regulatory bodies and appropriate ministries to support new registration requirements, maintenance of current product portfolio and all imports (eg CDSCO, IVRI, DAHD, CDTL, IPC, etc).

• Engage with the regulatory bodies to progress regulatory policy activities in line with local business, regional & global regulatory policy priorities

• 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

• Support key projects in the local and/or regional industry associations to collaborate and intensify priorities that facilitate our business and processes.

Internal Stakeholder Management:

• As the regulatory member on product development teams and commercial strategy teams, provide strategic, proactive, and timely regulatory expertise specific to the planning and execution of projects.

• Develop SOPs and provide regulatory input to product life-cycle planning

• Set registration timelines and milestones, and communicate with local team as well as global cross-functional units

People & Team Management:

• Lead India BNS RA organization to define RA Roadmap & Annual Focus according to business objectives and goals, align with Regional RA Lead & relevant functional leads, including communicating to key internal stakeholders.

• Oversee and develop a team of highly motivated, experienced and dedicated direct reports responsible for regulatory and quality functions

• Act as a resource to assist/guide colleagues on how to resolve issues and improve their own performance/contributions.

• Ensure sufficient team resources to perform the responsible scopes and explore initiative approaches to manage short-term workload if any.

Qualifications (Training, Education & Prior Experience):

· B.V.Sc / M.Pharm

· 10 Years + and team management experience

Key Competencies:

· Analytical Thinking

· Confidence and Commitment

· Collaboration with multifunctional teams across the company (local and global)

· Impact, Advocacy and Influence

· Interpersonal Sensitivity

· Planning & Prioritizing

· Agility

Special Skills & Knowledge:

· In depth knowledge of Veterinary Science preferred

· Multi-disciplinary technical knowledge

· Knowledge of manufacturing quality systems and processes

· Knowledge of regulatory laws and guidelines

· Knowledge of Import / Export regulations and 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.

· Team management and development experience.

Full time

Regular

Colleague

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