Director of Regulatory Affairs – Northeast

The incumbent is responsible for regulatory management to provide early guidance, review and approval of regulatory strategy, labeling and promotional material for new products.  This position coordinates the format and information in the development of regulatory submissions including U.S. Veterinary Biologics Establishment License Applications, U.S. Veterinary Biological Product License Applications, New Animal Drug Applications (NADAs), and Investigational New Animal Drug submissions (INADs).  The incumbent develops and conducts the training of R&D, Marketing, QA and other groups concerning regulatory issues; as well as evaluates and implements procedures pertaining to corporate regulatory activities.  Additional, the incumbent is responsible for developing complex domestic and global regulatory strategies and submission in support of new and existing marketing authorizations.  The incumbent will review and approve all labeling communications to trade publications, news media release, sales presentations and technical bulletins and analyze the support data for claims verification and for regulatory compliance.

Qualifications and experience include: Bachelor degree or higher in a biological science, animal science, chemistry, or a clinical field.  DVM or equivalent degree and/or Ph.D. are desirable with a minimum of five years’ experience in Regulatory Affairs or FDA/USDA experience as a reviewer of product applications.  Experience with NADAs and/or Veterinary Product License Applications. Understanding of 21 CFR 500-599 and/or 9 CFR 101-124. Drug and/or biologic manufacturing requirements and statistics and sampling methods.

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Project Manager – Drug Development

The Project Manager will support a development portfolio of animal health products targeted for the US and/or international markets. The work will consist of planning, execution and close-out of pharmaceutical and/or nutraceutical products for companion and large animals which will vary in scope and complexity. Responsibilities include establishing and supporting global projects teams while working in a matrix along with US Drug Development team and other experienced project Managers. Strategic multi-project level analysis will also be a part of this role.

Qualifications include BS or MS degree in a scientific area and/or  business management, experience as a project manager and/or project team leader for complex programs, demonstrated ability to lead global project teams, demonstrated ability to work in a matrixed environment, ability to manage complexity, ambiguity and change, experience with project portfolio management, experience with antiparasitics, pesticides and/or crop protection projects is highly desired, experience in a regulated, pharmaceutical and/or animal health industry is required.

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Director of Research & Development

The Director of R&D will lead, staff and manage the R&D team, improve efficiency and optimization of existing research operations, administrate and manage the grant, SBIR and other non-dilutive funding activities, lead the effort to publish research in peer-reviewed journals, work with Contract Research Organizations (CROs) to outsource both in vivo and in vitro research, develop and implement administrative tools to ensure success and ease of communication between research staff, validate current and future testing methods and experimental design, lead regular research department review meetings, be a subject matter expert (SME) for research department short-term and long-term growth strategy, lead and direct intellectual property/exploratory research development, regularly interface with management to ensure research operations reflect overall corporate vision/strategy.

Qualifications include: BS Degree in Biology, Chemistry, Material Science, Chemical Engineering or similar discipline, PhD or MBA in relevant discipline strongly preferred, 8-10 years’ experience in research administration, preference given to pharmaceutical experience, experience with grant and publication submission strategy, extensive knowledge of and strong track record with SBIR submissions to multiple agencies, including NIH and DoD, experience with large animal in vivo research including IACUC procedures preferred, familiarity with Medical Device Product development, understanding of Good Laboratory Practices (GLP) preferred, hands-on experienced with polymers, coagulation chemistry and/or material science strongly preferred.

Benefits: Paid vacation and holidays, medical dental and vision insurance, firm paid life and short-term disability coverage, 401k retirement savings plan with company match

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Director of Research and Development

We are looking for a geneticist for a global role for an international organization. The incumbent will lead existing breeding programs and develop new research projects according to the needs of customers all over the world.  The incumbent will become the trendsetter for future quality and features of food, will coordinate and consolidate the activities of research farms located in different regions of the world, manage a division of highly experienced employees on farms and in the headquarters, supervise the documentation and updating of processes and procedures related to the capture of phenotypic data and genetic utilization, large scale data processing and data analysis, be kept abreast in the areas of responsibility by establishing a network of industry and academia contacts, studying literature and attending scientific meetings, provide scientific advice to the technical service department to further enhance and maintain the performance of the birds.  The responsibilities include continuous development and improvement of the breeding stocks to increase rates of genetic gain for all traits under evaluation, support in the development of marketing material that highlight the competitive advantage of the company’s products.

Qualifications include a degree in agriculture or veterinary medicine, PhD in animal breeding/genetics preferred. Applications from candidates with similar degrees will also be considered.  Distinct expertise in the area of animal or crop breeding, experience in bioinformatics data analysis is desirable, strong communication skills, ability to travel internationally up to 25%, Sound knowledge of MS Office.  We are looking for a self-assured individual who is responsible and convincing.

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Scientific & Business Assessment Manager

(This could be 1 role or 2 roles). This is a new role that combines both business development and a scientific approach for evaluating ingredients and product sourcing.  The incumbent will assist in the development of new products for the Veterinary Division, including rationale, budget and project timeline and will assist in the development of product improvements and new product ideas. The incumbent will provide input and recommendations for business development proposals, prepare scientific abstracts and manuscripts for publication, including assisting in selection of relevant scientific journals, monitor new developments and current status of veterinary supplements and pharmaceutical clinical research projects, studies and trends. The incumbent will work with Veterinary Technical Services clinical study projects and communicate effectively with other departments within the organization.

Qualifications include a Veterinary Medicine degree along with knowledge of scientific principles and practices, excellent writing skills, interpersonal and communication skills, organizational skills, and computer literacy. Knowledge of MS Project is required. Three to six years of industry experience is preferred. Business development experience is also preferred.

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Research Chemist

This is an opportunity for a research chemist who has extensive research and development experience in novel pesticide formulas.

Qualifications include a Bachelor’s or Master’s degree from a college or university and four+  years of pesticide development, or a Ph.D with one or more years of pesticide development experience. We will also consider a Ph. D with one or more years of industry-related experience. Candidate must have served a key role in development of at least one unique product from concept to completion or which has generated an invention disclosure form or similar status up to and including successful patent registration.  Special preference will be given to candidates with practical experience formulating disinfectants.

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Manufacturing Associate

The Manufacturing Associate will serve as CMO Project Manager for prescription drug product candidates and non-prescription products . The successful candidate will be an experienced CMO project manager and critical thinker who will serve as a key contributor at an animal healthcare company. The successful candidate will manage all aspects of CMO relationships, including sourcing CMOs, preparing RFPs, negotiating terms and determining budgets. The incumbent will manage development, optimization and production of formulated materials, adhere to strict timelines and partner closely with regulatory.

Qualifications include a minimum of 3-5 years’ experience managing CMO relationships, including sourcing CMO’s negotiating terms and managing development, optimization and production of formulated materials, 2+ years of experience managing multi-million dollar budgets, PhD or MS degree with 2-4 years of experience (or a BS degree with 3-5 years’ experience) in formulation science from an accredited institution with strong emphasis in one or more of the following disciplines: biotechnology, biology, pharmaceutics, medicinal chemistry, chemical engineering, polymer science or pharmacokinetics. Other requirements include hands on  manufacturing experience at all levels (lab, pilot, full commercial(, proven understanding of cGMP, breadth and depth of understanding of the pharmaceutical/animal health industry (API, DP, packaged product formats) with an emphasis on API experience, working knowledge of CMC Guidance for veterinary products, regular travel to domestic and global CMO’s, experience working independently and in multi-disciplinary, geographically dispersed teams, strong analytical and problem solving skills, ability to learn quickly and adapt to change, good communicator, ability to travel in the US as well as travel internationally and be able to overcome obstacles.

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Regulatory Affairs Manager

We are seeking a hands-on Regulatory Affairs Manager to manage the day to day regulatory activities and cross-functional initiatives as part of mid-level management of prescription product portfolios in the animal health industry; both companion animal and equine. The successful candidate will be responsible for the maintenance, registration and re-registration of products as well as ensuring regulatory compliance of products. Candidates must be skillful strategists and critical thinkers who are excited about the opportunity to serve as a direct contributor. The successful candidate will handle registration and maintenance of existing and future marketing authorizations in accordance with business needs, directions and strategies and will plan direct and coordinate regulatory activities for assigned products in collaboration with manufacturing and QA, ensuring successful implementation, follow through and completion of tasks. The incumbent will prepare, write and review technical reports and documents for products and those in development according to the latest regulatory requirements, will coordinate the technical documentation process and ensure that the required CMC documents are generated to the appropriate quality standard, will ensure regulatory compliance by creating awareness of requirements and guidelines, facilitation timely submissions and strict participation in the local change control operations. The incumbent will  build and maintain procedures and systems necessary to maintain proper records and support adequate controls, review labeling, promotional and commercial literate and maintain current knowledge of applicable regulatory requirements and guidelines.

Qualifications include 2+ years of experience in Regulatory Affairs, preferably in Animal Health, combined with knowledge in product development or equivalent experience, demonstrated success in planning and leading regulatory projects as a project manager. Scientific degree in an appropriate biomedical subject (e.g. life sciences, biology, chemistry, pharmacy), experience working both independently and in multidisciplinary, geographically dispersed teams, experience submitting documents to CVM electronically, knowledge of European registration process a plus.  Excellent organizational skills; demonstrating ability to handle multiple projects concurrently, ability to take initiative to identify challenges and solve problems in an efficient, positive manner, detail-oriented and able to maintain accuracy in a fast-paced environment, adept with MS Office suite, Adobe MS Project and other software, excellent writing and communication skills, ability to learn quickly and adapt to change, able to work collaborative across functions as a member of the team, resourceful and achieving genuine results.

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International Regulatory Affairs Manager

The International Regulatory Affairs Manager will manage day to day regulatory activities and cross-functional initiatives as part of mid-level management of prescription product portfolios in the animal health industry; specifically in the companion animal and equine animal sectors. The successful candidate will handle the maintenance, registration and re-registration of products as well as ensure regulatory compliance of products primarily in Europe and ROW. Candidates must be skillful strategists and critical thinkers who will serve as a direct contributor at this innovative and emerging animal health organization. The incumbent will coordinate the technical documentation process and ensure that the required CMC documents are generated to the appropriate quality standard and will ensure regulatory compliance by creating awareness of requirements and guidelines, facilitating timely submissions and strict participation in the international change control operations. The incumbent will manage the label approval process for regulatory affairs with minimal supervision and assure that product label claims are in compliance with all relevant laws and regulations. The successful candidate will direct post-approval regulatory activities such as, post-approval commitments, supplements/variations, annual reports and change control .

Qualifications include 2+ years of experience in regulatory affairs, preferably animal health, combined with knowledge in product development or equivalent experience. Demonstrated success in planning and leading regulatory projects as a project manager and a scientific degree in an appropriate biomedical subject (ie: life sciences, biology, chemistry, pharmacy) is required. The successful candidate will have strong knowledge of EU-ROW registration processes and regulatory requirements and has excellent organization skills and ability to handle multiple projects concurrently. Other qualifications include ability to travel 50% of the time internationally, ability to learn quickly and adapt to change, ability to work collaboratively across functions, resourcefulness and a strong communicator.

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Director, CMC Regulatory Affairs

Our client is seeking a senior-level regulatory affairs director to lead the CMC pre-approval and post-approval regulatory activities of its prescription product portfolios in the companion and equine animal space. The company is committed to identifying animal health market opportunities where it can develop species-specific products that leverage its broad intellectual property portfolio, deep pipeline and extensive botanical library. The successful candidate will direct all CMC regulatory initiatives, providing regulatory expertise, a strong network of animal health industry contacts and proven success in the approval of new and innovative products for production animals and/or companion animals. Candidates must be skillful strategists and critical thinkers who are excited about the opportunity to serve as a direct contributor at this emerging and innovative organization.

Qualifications include 5+ years of experience in veterinary pharmaceutical CMC regulatory role with demonstrated success in achieving regulatory approvals for veterinary pharmaceuticals, experience writing CMC electronic submissions to FDA-CVM and subsequently obtaining NADA’s, a scientific degree in an appropriate biomedical subject, experience working both independently and in multidisciplinary, geographically dispersed teams, ability to prepare and present information to regulatory agencies and other scientific groups, experience submitting documents to CVM electronically, knowledge of European registration process a plus, solid understanding of the manufacturing and testing of veterinary pharmaceuticals, skilled at using the electronic submission process of CVM, excellent organization skills demonstrating ability to handle multiple projects concurrently, detail-oriented and able to maintain accuracy in a fast-paced environment, adept with MS Office suite, Adobe and other software, excellent medical/technical writing and communication skills, ability to learn quickly and adapt to change, good communicator who is resourceful and able to overcome obstacles and willing to achieve genuine results by bringing a creative approach to issues.

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