Other responsibilities include to participate in meetings with regulatory authorities to present and explain the position of our client company with respect to study requirements or concerns associated with the toxicology or safety of specific products. Establish partnership-based working relationships with scientific experts within regulatory authorities and facilitate the scientific and regulatory review process for our client’s products.  Incumbent will contribute to the risk assessment process by providing input to product safety managers/risk assessors on hazard identification, dose-response interpretation, use of mechanistic data and interpretation of toxicology profiles integrating information from other disciplines into the overall toxicological assessment. Incumbent will ensure Quality Assurance/Regulatory compliance and participate and/or lead administrative and procedural activities such as development of new Standard Operating Procedures.

Qualifications include PhD with board certification in toxicology or an advanced degree (MS or PhD) in addition to a DVM is desirable and should be in toxicology or a related field of pharmacology, pathology, etc.  Five or more years of experience in product development.

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Qualifications include a DVM and/or a PhD in an animal health related field. An advanced degree (MS or PhD in addition to a DVM is desirable.

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The Principal Scientist will function as Study Director for such product evaluations. This will include the originating, designing, conducting, and/or directing surgical and bench top investigations. The role is also responsible for improving upon and developing new preclinical surgical models for medical device evaluations.

The Principal Scientist will also use his/her expertise to serve as an internal consultant on interaction of various tissues with medical devices. The individual will be expected to manage multiple projects, either internally or externally. The individual will be expected to develop project plans and coordinate plans with both the larger project team and other preclinical associates. The Principal Scientist will also be expected to propose and design their own research & development projects & execute resource planning and originate, design, conduct and/or direct surgical investigators. Finally the Principal Scientist will also actively participate and collaborate with the external scientific community to further the scientific standing of the department.

Qualifications: A minimum of a DVM from an AVMA approved and accredited program is required. Board Certification is strongly preferred but not required. A Master’s and/or PhD is preferred. Veterinary surgery experience utilizing veterinary models is required. Preclinical study model design experience is required. Experience as a Study Director/Leader for product evaluations is strongly preferred. Medical Device development experience is preferred. Small animal and soft tissue experience is preferred. Experience working with cross-functional groups/teams is preferred. Leadership experience/ability is strongly preferred.

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Qualifications include a DVM/VMD from an AVMA approved and accredited program or equivalent degree is required. Board certification is strongly preferred but not required. Surgical residency training and/or industry experience (minimum 3 years in industry without residency) is required.

Scientific publications are required. Experience working in a team environment is also required. Highly motivated, self-starting and strong verbal written communication skills are required to handle this position effectively.

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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. 

The Director  must have 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.

Qualifications

• BS/MS, preferably in scientific field (chemistry, biology, animal science, etc.).
• Graduate or professional training a plus.
• Experience in research and regulatory veterinary medicine including interaction with governmental agencies.
• Understanding of the product development process, including establishing development 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 and experience with 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 Pharmacovigilance requirements in the US and Canada .

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Responsibilities:

• Coordinate all licensing procedures with the FDA, EPA, etc
• Provide representation on regulatory/technical committees of the trade association AHI
• Provide leadership by guiding staff in the management of submissions.
• Communicate emerging legislation and its consequences within the regulatory affairs group and across other functions
• Initiate product stewardship activities for existing product line in the US

Qualifications:

• PhD or DVM degree in animal science-related
• At least 10 years experience in regulatory affairs and CMC, with at least 5 years experience in the animal health industry
• Demonstrated leadership abilities, the ability to work independently and strong negotiation skills dealing with 3rd parties

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The Director will also provide scientific support and direction as needed by each of the teams. The Director will assist with Technical Services in resolution of difficult complaints by providing scientific guidance relating to customer issues. The Director will work with the Regulatory Affairs Manager to provide guidance to other departments for compliance of regulations. The Director is responsible for ensuring all packaging, external communications, marketing materials and collateral materials are consistent in messaging and adhere to the company’s philosophy. The Director is responsible for providing content for technical marketing pieces as needed. The incumbent will also direct quality communications to the market for providing feedback from the market on quality issues to QA and the management team. In addition the Director will provide scientific articles to external publications to promote the reputation of the company. They will work with QA on quality issues, will set up standard operating procedures regarding quality complaints, will provide responses based on findings in QA investigations and will assist in training the team on quality assurance and food safety.

Qualifications include: Doctor of Veterinary Medicine or other advanced degree. It is preferable to have board certification. Excellent communication and presentation skills (oral and written), excellent PC skills (Excel, Word, Power Point) required. Outgoing personality and the ability to function as a team leader.

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Duties include managing environmental regulatory matters for products, including registration and registration reviews, product development regulatory support, planning, budgeting, and direct management of regulatory specialists, compliance, etc.

Qualifications 

• M.S. or PhD. preferred in a technical field such as Engineering, Chemistry, Biology, Industrial Hygiene, Safety or Environmental/Public Health.
• Minimum 5 years experience in Pesticide Regulatory Affairs or Animal Health Regulatory Affairs
• Knowledge of federal and state environmental regulations and procedures, including knowledge of U.S. laws pertaining to the regulation of pesticides under the Federal Insecticide Fungicide and Rodenticide Act (FIFRA), knowledge of pesticide laws.
• International regulatory experince a big plus
• Excellent written communication and presentation skills
• Spanish and/or Portuguese language skills would be desirable

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Other responsibilities include making sure the products are in compliance with the necessary requirements for export and to develop and maintain protocols and procedures for export to desired countries. Incumbent will be responsible for providing responses to regulatory inquires from federal or state agencies and will be responsible for understanding the regulatory implications world events have on our client’s business. (i.e. swine flu, avian flu). Incumbent will provide training on label compliance to marketing associates in all North America subsidiaries that utilize the same packaging materials and will perform various other regulatory and trademark functions as needed.

Qualifications include prior experience in pharmaceutical or pet food regulation, excellent communication and proof reading skills, excellent PC skills (excel, Word, PowerPoint), ability to function as a team player and coordinate projects with associates in various departments, ability to build networks and influence others.

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The Manager, Product Development will be responsible for managing companion animal veterinary product development projects at contract labs and the science supporting drug development and the associated laboratory and clinical studies.

Key responsibilities include: evaluation of potential development issues, management of select domestic and international product development projects, planning and execution of animal studies for drug applications, analysis of animal study data, and preparation of documents supporting studies and product submissions to the FDA.

The Manager, Product Development will report to the Director, Product Development and the Manager position will be hired after the Director position.

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