(314) Area code                                                                             Missouri

Director of Regulatory Affairs

Reports To: Vice
President, Research & Development  Department:  R&D, Regulatory Affairs

Description:  The
Regulatory Affairs Group, as part of our Research and Development, is critical
for the ongoing support of a wide range of existing products, and the
development of new products.  The
regulatory affairs group consists of a team of skilled professionals working to
meet Regulatory, Operational, Business and Scientific objectives.  The Director
of Regulatory Affairs is the principal source of regulatory information
and advice for the company, in addition to being a working manager, providing
guidance to the other regulatory affairs staff, and overseeing the regulatory
affairs group.  Strong people
management/coaching skills, effective coordination of the entire team, a
broad-based knowledge of US and Canadian Regulatory issues, and an ability to
work with every group within the organization are critical to the success of
the R&D effort and require the skills and talents of highly competent and
energetic colleagues.  The Director is a
hands-on position that must also be able to synthesize, strategize, plan and coordinate
the present and future activities of a diverse team of professionals.  The position requires a people oriented
person that is experienced, motivated, disciplined, flexible, action-oriented, and
results driven.  Most suitable would be
an effective manager and communicator, and a seasoned problem solver with
uncompromising integrity.

Broad Function:  Be the principal regulatory authority within our , our US group.
Oversee and be responsible for the Regulatory Affairs group which serves as the
principal point of contact with state and federal regulatory entities, ensuring
that the Firm is fully aware of governing regulations and exhibits the highest
product and corporate standards. Provide broad and specific direction to
establish technical and strategic visions for the Regulatory Affairs group to
drive ongoing process and operational improvements consistent with the business
objectives.  Provide sound risk
assessment regarding manufacturing changes.

 Support new product registrations
of pharmaceutical, biological and pesticide products in the US and Canada.  Ensure the Business remains in regulatory
compliance with respect to its products. 
Serve as the group leader for the Regulatory Affairs Department.

Manage the personnel and
budget of the Regulatory Affairs department while creating a positive work environment
that balances the needs of the company for disciplined, efficient and timely
outcomes with staff needs for a creative, innovative, rewarding and fun
workplace.

 Essential Functions:

• Work directly with regulatory agencies - the US Food
  and Drug Administration, US Department of Agriculture, US Environmental
  Protection Agency, Canadian Veterinary Drugs Directorate, Canadian Food
  Inspection Agency, and Canadian Pesticide Management Regulatory Agency to
  register and maintain product registrations
• Oversee the Firm’s Regulatory Affairs
  Department. 
• Prepare and manage the departmental budget. 
• Establish, maintain and supervise an effective
  organizational structure and staff. 
• Effectively communicate both detailed and
  high-level information to Senior Management.
• Develop, model and lead organizational
  principals, concepts, procedures, and practices that result in sustained,
  high quality and highly credible business operations.
• Lead preparation of and participate in
  preparation of dossiers and routine filings and reports.
• Develop strategies for registration of NADA,
  ANADA products and equivalent, in consultation with regulatory agencies. 
• Interpret regulations, guidelines,
  communications, and policies so as to enhance the effectiveness of
  Business Operations, Industrial Operations, and Research and Development.
• Provide feedback on proposed manufacturing
  changes regarding commercialized products.
• Review promotional materials for regulatory
  compliance and act as regulatory expert to development teams and business
  colleagues.
• Coordinate with international colleagues and successfully
  manage consultants and relationships with businesses outside our organization to
  facilitate product transfers to and from the US.

Additional Responsibilities:

• Provide regulatory input to Project Development Staff
  and Teams.
• Recommend, recruit and supervise the work of
  outside consultants.
• Support Industrial Operations efforts to
  maintain quality, efficiency, and GMP compliance.
• Provide regulatory advice on Pharmacovigalence.

Education:

• BS/MS, preferably in scientific field
  (chemistry, biology, animal science, etc.).
• Graduate or professional training a plus.

Knowledge, Skills,
and Abilities:

• Experience in research and regulatory veterinary medicine
  including interaction with governmental agencies.
• Understanding of the product development process,
  including establishing development strategies, plans protocols, research
  reports, and reporting.
• Experience in assembling product dossiers for submission to
  Regulatory Authorities.
• Understanding of regulatory perspectives relative to Chemistry,
  Manufacturing and Controls (CMC) in a GMP environment.
• Familiarity with the principals of pharmaceutical manufacturing.
• Excellent technical writing skills.
• Command of GLP cGMP and GCP concepts.
• Experience with EPA Data Call-in and re-registrations is
  preferred.
• Experience and/or detailed knowledge of pharmacovigalence
  requirements in the US
  and Canada.