knoell is a global company headquartered out of Germany that researches, processes and evaluates scientific data across all scientific specialties. Our vision is to be the trusted industry leader in worldwide regulatory solutions. We compile registration dossiers and submit them to national and international authorities. The size of our company allows us to act as a full service provider and assemble a team of the required size and expertise to serve clients in agrochemical, biocides, industrial chemicals, product safety, veterinary medicine and medical devices.
At knoell Animal Health, LLC, you are part of an international team of more than 45 Animal Health experts including specialists in pharmaceuticals, biologics, feed additives, toxicology, safety, chemistry and clinical studies.
We support manufacturers of animal health products with our extensive expertise at every point of the product life cycle. Our animal health experts support our clients in gaining access to global key markets like Europe, North & South America and Asia.
The Manager Veterinary Product Development leads client-facing projects and submissions for regulatory approvals, acting independently to identify, characterize and resolve problems. This manager applies advanced regulatory expertise and demonstrates strategic thinking and creativity in support of client’s projects.
The successful candidate will possess strong knowledge of one or more of FDA, USDA, or EPA regulations and guidance documents pertaining to the regulation of animal health pharmaceutical, biological, and/or pesticide products and will have authorship experience of relevant key regulatory submissions.
This position will have strong communication and negotiation skills in a client-driven environment.
- Manage projects involving the development of regulated veterinary products, including setting up projects within the knoell ERP system.
- Compile proposals for projects and negotiate contracts with both clients and third parties.
- Monitor and track project time and pass through costs budgets
- Ensure the direction of members of the team selected for roles in the project by organizing and leading project meetings.
- Attend and organize client and third party visits and meetings.
- Maintain regulatory documentation and compile regulatory dossiers using knoell Animal Health templates in accordance with appropriate regulations.
- Liaise with Regulatory Agencies and attend agency meetings and hearings.
- Assess or assist in the assessment scientific data and compile scientific reports for the pre-clinical and clinical development of a veterinary medicine and other animal health products.
- Compile or review pivotal regulatory documents for submission to federal agencies, including documents or dossiers for safety, effectiveness, and/or manufacturing.
- Undertake gap analysis / data audit of data files provided by clients versus current legislative requirements.
- Provide strategic advice in the development of veterinary medicine and other animal health products; including the preparation of strategic reports and project development plans.
- Conduct technical due diligence of animal health associated assets held by another company.
- Overview of regulatory studies (performed in compliance with Good Laboratory Practice (GLP) or GCP or other applicable standards) conducted by third parties related to the development of veterinary vaccines or pharmaceuticals, in the role of Sponsor Representative.
- Entry of study data and/or Company administrative data into spreadsheets and databases. Verification of this data when applicable by using established quality control techniques. Analysis of data using simple functions, including statistical features, to prepare tables, graphs, charts and reports.
- Adhere to the following in all appropriate aspects of the position:
- Maintain documentation, records, data in general adherence to applicable standards, internal quality systems and policies of knoell Animal Health.
- Communicate with clients and other external bodies in line with company policy.
- Conduct other work suitable to abilities, training, experience and position, as requested. This may include administrative tasks and assistance to other Company personnel.
- Bachelor’s degree (or equivalent) required, preferably in animal science, biology, or related life science/medical fields. Advance degree (DVM/VMD, MS, or PhD) preferred.
- Minimum of 5 years of animal health regulatory experience with one or more of FDA-CVM, USDA-CVB, and/or EPA.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Strong verbal and written communications with ability to communicate effectively at multiple levels in the organization, regulatory agencies, and the client’s organization if applicable.
- Experience with regulatory agency negotiations
- Strong organizational and follow-up skills, as well as attention to detail.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to work independently with limited oversight.
- Ability to identify and solve problems in a strategic manner.
- Ability to be proactive and anticipate changing regulatory environments.
At knoell Animal Health, LLC you will be working in a professional, fast-growing, international organization. We offer a competitive compensation package teamed with comprehensive benefits.