Regulatory Affairs Specialist

Role & responsibilities

• Ensure that a company's veterinary biological/animal vaccines products comply with the regulations of the regions where they want to distribute them
• Develop and write clear arguments and explanations for new product licenses and license renewals
• Monitor and set timelines for license variations and renewal approvals
• Prepare documents for registration of products in India (Form 12/44/40/8), Bangladesh, Sri Lanka and Nepal.
• Ensure all products labels are in alignment with the regulations of the importing countries.
• Safe keep confidential documents
• Provide strategic advice to senior management throughout the development of a new product
• Coordinate and support animal trials when required
• Review company practices and provide advice on changes to systems
• Assist in arranging internal and external meetings
• Organize travel arrangements
• Preparation and submission of bills to finance department
• Ensure that updated SDS and product description sheets are available

Preferred candidate profile

• Masters degree in Chemistry / Biochemistry / Veterinarian / Microbiology with 3 to 7 years experience.
• Knowledge in regulatory aspects related to animal vaccines/biologicals and feed industry is preferrable.