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Senior Regulatory Affairs Manager - Animal Health

Job Title: Senior Regulatory Affairs Manager - Animal Health
Contract Type: Permanent
Location: Thailand, Thailand
Industry:
Salary: Negotiable
Reference: 30616_1563519018
Contact Name: Mark Pandey
Contact Email: mark.p@criterionasia.com
Job Published: July 19, 2019 13:50

Job Description

  • Critically review, approve and direct strategy for regulatory. Facilitate timely regulatory approval by managing adherence to the Regulatory Affairs schedule for new applications and deficiency responses. Direct activities to ensure the required documentation is prepared to a high standard, submitted in a timely and appropriate manner, that proper change control approval has occurred, and that all regulatory requirements and/or commitments are met.
  • Interact effectively with Product Development, Operations, Quality, Regional Regulatory and Third-Party Manufacturing and Testing Partners by ensuring regulatory requirements are clearly communicated to project teams (internal and external) to ensure that FDA regulations and expectations are met.
  • Provide strategic recommendations and direction to technical teams to reduce regulatory risks and minimize delays associated with submission and/or commercialization of products being developed. Communicate proposed risks and risk mitigation strategies to Senior Leadership.
  • Continue development of positive relationships with FDA, Notified Body and other Regulatory Agencies as appropriate
  • Evaluate the impact of communications received from the FDA, other regulatory authorities
  • Maintain knowledge of current and emerging regulatory requirements; disseminate and discuss with appropriate team members. Establish procedures and processes to meet changing regulatory Health Authority requirements.
  • Input and adhere to departmental budget.

Qualification:

  • Minimum of a bachelor's degree (or equivalent) and 5 years of experience. A Master's degree (or equivalent) and 10 years of Regulatory experience preferred.
  • Must have strong experience in Animal Health
  • Strong connections in the Government authorities.
  • Must adhere to Company and Department policies and procedures as well as government regulations. Requires understanding Food and Drug Administration (FDA) regulations.
  • Must possess competent computer skills, including in depth knowledge of word processing, spreadsheets, PowerPoint and database concepts. Requires extreme attention to detail and exceptional organizational and communication skills.
  • Ability to multi-task a large number of projects and evaluate priorities.
  • Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence.
  • Ability to work with groups of people such as other departments and communicate known concepts. Ability to present to a group of departments.
  • Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis. Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems.
  • Proficiency in speaking, comprehending, reading and writing English is required.

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