Regulatory Affairs Manager

3 weeks ago
Requisition ID
2017-3252
Job Location(s)
Bloomington IN United States
Travel
20-30%
Shift Type
First
Position Type
Full Time
Company
Cook Animal Health Inc.
Category
Regulatory Affairs

Overview

The Regulatory Manager for Cook Animal Health will manage all regulatory aspects of products from inception through commercialization. Along with anticipating Regulatory Affairs department and project needs, this person will execute appropriate actions to move the department and the project forward in a compliant and efficient manner.

Responsibilities

• Responsible for all regulatory submission aspects of ANADAs, NADAs
• Identify data needed, prepare and/or obtain data and review to ensure that they are effectively presented for the registration of products
• Determine and communicate submission and approval requirements
• Assess the acceptability of CMC and BE documentation for submission
• Monitor impact of changing regulations on submission strategies
• Develop SOPs and provide regulatory input to product life-cycle planning
• Maintain annual licenses, registrations, listings and patent information
• Assist compliance with post marketing approval requirements
• Develop, review and approve advertising, promotional and social media items to ensure regulatory compliance
• Compile, prepare, review and submit applications to authorities
• Develop regulatory strategies for development products and changes to commercial products

• Ensure product safety issues and product associated events are reported to regulatory agencies
• Review changes to products and assess the regulatory impact on affected registrations
• Represent company in industry organizations, seminars, workshops, etc

Qualifications

• Bachelor's degree with a preference for advanced training in Science, Chemistry,or Veterinary Medicine; or experience of such kind and amount as to provide a comparable background 
• A minimum of 5 years experience in Regulatory Affairs, with ~10 years being in a regulated industry strongly preferred
• Adobe Acrobat Pro and Microsoft Office expertise

• Knowledge of the drug development submission and approval process
• Familiar with CVM structure, processes and key personnel
• Prior success managing multiple projects simultaneously in a fast-paced environment
• In depth knowledge GXPs (GCPs, GLPs, GMPs), RAC preferred
• Exhibit high attention to detail with excellent communication skills

 

Physical Requirements:

• Works under general office environmental conditions.
• Sitting for extended periods, utilizes close visual acuity for working with computers, etc.
• Ability and willingness to travel

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