Head of Regulatory - San Francisco, CA | Biospace
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Head of Regulatory

Jaguar Animal Health, Inc.

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Location:
San Francisco, CA
Posted Date:
11/9/2016
Position Type:
Full time
Job Code:
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:
Animal, Assay Development, Regulatory, Regulatory Affairs,

Job Description

Jaguar Animal Health (www.jaguaranimalhealth.com) is seeking an experienced regulatory affairs executive to lead the registration of its early-stage prescription product portfolios in the companion and equine animal sectors. 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 drive all US and OUS regulatory initiatives at Jaguar, 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 C-level contributor at this innovative, emerging animal healthcare company. This hands-on position will be based out of Jaguar’s San Francisco headquarters and report to Jaguar’s CSO.

Core Responsibilities:
•   Direct submission activities for a variety of veterinary pharmaceuticals.
•   Compile and submit registration dossiers to FDA CVM in a timely manner with minimal supervision (and provide follow-up).
•   Direct and manage interface/written communications on regulatory and technical matters with FDA CVM as well as regulator responses to submissions.
•   Prepare and coordinate CMC areas of submissions to CVM; review manufacturing documentation and reports.
•   Drive all OUS regulatory efforts in selected markets.
•   Provide regulatory support to project teams and other departments at Jaguar.
•   Maintain current knowledge of applicable regulatory requirements and guidelines.
•   Manage label approval process for regulatory affairs with minimal supervision. Assure that product label claims are in compliance with all relevant laws and regulations.
•   Prepare dossiers to obtain MUMS designation.

Requirements

Experience:
•   4+ years of experience in veterinary pharmaceutical regulatory role with demonstrated success in achieving regulatory approvals for veterinary pharmaceuticals.
•   Experience should preferably include writing submission to FDA CVM and subsequently obtaining NADAs.
•   A scientific degree in an appropriate biomedical subject (e.g. life sciences, biology, pharmacy, veterinary medicine, engineering).
•   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.
 
Skills:
•   Excellent organizational skills demonstrating ability to handle multiple projects concurrently
•   Skilled at using the new electronic submission process of CVM.
•   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.
 
Personal Characteristics:
•   Ability to learn quickly and adapt to change.
•   Able to work collaboratively across functions as a member of the Jaguar team.
•   Strong achievement and results orientation, with a roll up your sleeves attitude.
•   Good communicator and listener who tests for understanding and is clear and concise.
•   Resourceful, overcoming obstacles and achieving genuine results by bringing a creative approach to issues.
 
Other important parameters for this position:
•   Compensation and benefits package includes attractive stock options component.
•   Domestic and international travel will be required.
•   Qualified candidate must be authorized to be employed in the United States.