Manager​/Associate Director, US Regulatory Affairs

Manager/Associate Director, US Regulatory Affairs page is loaded## Manager/Associate Director, US Regulatory Affairs locations:
Kalamazoo - Downtown Portage Streettime type:
Full time posted on:
Posted Todayjob requisition :
JRThe successful candidate will be the regulatory strategy lead for US FDA regulated products, providing guidance and technical support for new product registrations and supplemental claims as a part of global veterinary pharmaceutical and biopharmaceutical development project teams. The person will be responsible for ensuring that these products are developed, approved, and maintained in full compliance with Food and Drug Administration Center for Veterinary Medicine (FDA-CVM) requirements.

The candidate will lead strategy and interactions with FDA-CVM to enable product approval. To accomplish these responsibilities, the candidate will work closely with colleagues across Veterinary Medicine Research and Development (VMRD) and Global Portfolio Marketing (GPM) to facilitate product development, approval and maintenance consistent with the company operating plans and the project portfolio. The candidate will also liaise with EU and CALAR regulatory colleagues to support global registration activities, where appropriate.
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* Key responsibilities:

*** Serve as regulatory subject matter expert and member on multidisciplinary project teams (food and companion animal) responsible for developing veterinary pharmaceutical and biopharmaceutical products. Develop and implement the regulatory strategy for assigned teams, accepting the responsibility of all US FDA regulatory submissions and interactions for that project.
* Serve as liaison with Global Research and other VMRD colleagues to help provide early regulatory input into early phase projects.
* Liaise with GPM and Therapeutic Area Leads to establish suitable product profiles, regulatory jurisdiction, label claims, product support materials, as well as project progression documentation.
* Assemble original and supplemental applications and coordinate subsequent responses to US Regulatory Authority questions. Liaise directly with FDA-CVM as needed to achieve objectives.
* Liaise with EU and CALAR regulatory staff to facilitate global registration activities, where appropriate.
* Provide regulatory support and guidance regarding Global Manufacturing initiatives and Commercial market enhancements.
* Serve on industry working groups to engage with FDA-CVM on current and proposed policy and regulation.
** Minimum Skills, Education, Experience and Attributes:
*** Master’s or DVM and/or PhD degree, in a relevant scientific discipline (animal science, veterinary medicine, immunology, toxicology/pharmacology or similar).
* 8+ years’ experience between US regulatory affairs and a related animal health discipline, involving interaction with the FDA-CVM.
* Demonstrated abilities in areas of regulatory interpretation and procedures including phased, original, and supplemental applications.
* Understanding of the veterinary medicinal product development process, including early and late-stage development activities.
* Knowledge of safety/efficacy and dossier assembly for FDA-CVM.
* Knowledge in the production and testing of biopharmaceutical veterinary medicinal products is desirable.
* Excellent oral and written communication and negotiation skills and a demonstrated ability to multi-task and work in a global team environment (including virtual).
* Fluency in English required..
* Excellent functional knowledge of Microsoft platforms and associated Office suite programs.
* Well-developed verbal and written communications skills and organizational strategies.

Full time

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