Work as Executive - Regulatory Affairs at Zoetis

Zoetis is a global animal health company dedicated to supporting customers and their businesses in ever better ways. Building on 60 years of experience as Pfizer Animal Health, we deliver quality medicines and vaccines, complemented by diagnostics products and genetics 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: Executive - Regulatory Affairs (54321)

Job Description
Strategic/ Policy
-Plan, coordinate, and implement timely and effective processes for registration of new products and indications, and new LPDs(Local Product Documents), existing products (re-registration), etc.
-Identifies macro economic and industry specific trends of relevance to Zoetis in India. Projects industry changes over the planning horizon and develops strategies to best respond or leverage on changes

Operational

New Product Registration
-Will handle all issues relating to new product registration, including preparation / customisation of dossier, submission, correspondence, and follow-up to closure of outcome.
-Negotiates clinical trial contracts with Investigators regarding research grants. Ensures compliance with local laws and with Zoetis SOPs
-Will be a member of the new product committee and would give timelines for regulatory feasibility requirements

Product Maintenance and Defense
-Will be responsible for assuring maintenance of approval status for all marketed products, including proactive suggestion of strategies when appropriate, and measures for regulatory safeguarding and defense of marked products, if required

Regulatory Documentation
-Will be responsible for maintaining all regulatory documentation in compliance with country regulations this will include maintaining databases of regulatory status and other pertinent details Customer Care
-Looking into product queries, trials, demonstration studies, complaints, publications and databank

External Regulatory Responsibilities
-Will manage regulatory actions related to associated markets such as Pakistan, Nepal, Sri Lanka and Bangladesh
-Will participate in activities directed towards influencing regulatory change and encouraging regional and international harmonization

Financial
-Have registration costs incorporated into the departmental budget
-Support relevant departments on sales tax issues, Excise / Customs disputes, imports / exports.

Technology
-Liaison with the IT function in order to develop systems for updating and maintaining regulatory records
-Identify technology solutions for enabling better information availability

Candidate Profile
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

Key Competencies
-Analytical Thinking
-Confidence and Commitment
-Customer Service
-Impact and Influence
-Interpersonal Sensitivity
-Planning & Prioritising

Additional Information:
Qualification: B.V.Sc / M.Pharm
Location: Mumbai Suburban
Job Ref: 54321
Industry Type: Pharma/Biotech/Clinical Research