Regulatory Affairs Manager

Less than 5 years experience  •  Business Services

Salary depends on experience
Posted on 11/15/17
Westbrook, ME
Less than 5 years experience
Business Services
Salary depends on experience
Posted on 11/15/17

Job Description

7,000 people, one global focus - enhancing the health and well-being of pets, people, and livestock.  We are passionate about what we do at IDEXX – and why wouldn’t we be? When you’re working to raise the standard of care for pets, make drinking water safe for billions and keep our livestock population around the globe healthy and free of disease, it’s no wonder that what we do each day is more than just a job. There’s an energy across IDEXX that is contagious – where caring and committed people come together to make things better. The Regulatory Affairs and Quality Assurance (RQA) functions within the Business and Legal Affairs team support the creation of long term value for IDEXX by ensuring product quality and product compliance with regulatory requirements worldwide. 

Your core responsibilities:

  • Maintain knowledge of current as well as upcoming changes in industry, and regulatory developments that affect the Company and informs management as appropriate.
  • Work closely with all members of the team in managing general regulatory projects.
  • Develop understanding of Company’s business operations and ongoing related Regulatory issues in order to proactively identify and mitigate these risks. 
  • Participate and represent Regulatory on New Product Development and existing Product Support Teams
  • Develop and manage projects for process improvement, quality management, and cost/benefit assessment.  Generate ideas and solutions, prioritize based on business needs and resources, implement and sustain results.
  • Support the development, monitoring, and control of department policies and procedures.
  • Develop strong business relationships with internal customers and with other departments.

Your functional responsibilities:

  • Responsible for managing regulatory approval process.
  • Provide regulatory assessment of the North American region, provide guidance and recommend strategies for regulatory approvals; assist with global product registration considerations as well as related business and marketing implementation as needed
  • Develop, prepare and coordinate product dossier, and document packages for regulatory submissions.
  • Maintain product approvals (licenses, permits, facility registration)
  • Review and drive changes for labeling, manufacturing, marketing and other means of making product claims
  • Ensure consistency between marketing materials and product inserts and labels
  • Review and approve outlines of production, data packages and other product documentation
  • Provide guidance on interpretation and application of specified regulations and develop and implement processes as needed 
  • Responsible for building and growing relationships with regulatory agencies
  • Responsible for identifying, developing and managing relationships directly with regulatory agencies or local representatives
  • Negotiate with government and other agencies requirements for product approvals 
  • Assume active roles in various regulatory and standards development related stakeholder groups working towards influencing new regulations/standards and removing regulatory barriers
  • Responsible primarily for ensuring compliance with USDA and CFIA regulatory requirements as well as support (as needed) for targeted county requirements in the global marketplace.
  • Developing and maintaining reporting systems and tools
  • Reporting on monthly, quarterly and or annual basis
  • Support and help manage internal and external audits as required
  • Develop and implement systematic processes for compliance with applicable regulations and monitor their effectiveness.
  • Keep informed of professional and global regulatory information, procedures and changes. 
  • Inform the organization of changes in procedures or regulations that impact the Lines of Business
  • Support internal and external customer requirements
  • Review marketing materials for language accuracy and compliance to US USDA marketing regulations

Job Qualifications

Must haves/desirables:

  • Expertise and experience in regulatory affairs in the Biological industry. Experience in Animal Health and/or veterinary medicine preferred.
  • Possesses excellent Leadership skills in a global environment and possesses a “can do” attitude.
  • Excellent problem-solving skills, sound judgment and strong interpersonal, presentation and communication skills.
  • Strategic-thinker, goal- and team-orientated, able to handle difficult issues in a professional, assertive and proactive manner and history of developing cross-functional relationships with all levels of an organization. 
  • Practical, business-oriented approach to problem-solving, tempered by an appreciation of legal complexity and risk.
  • Facilitates and participates in process improvements across teams and organizations.

Requirements:

  • Bachelor’s degree in biology, chemistry or related scientific field. Masters, DVM or Ph.D. preferred
  • 3+ years’ experience in diagnostics or vaccines.  Animal Health or veterinary medicine preferred. 

Other:

  • Some domestic and international travelrequired (roughly 10-15%)

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