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Summary
Sentrx Animal Care, Inc., located in Salt Lake City, Utah, has been recently acquired by Domes Pharma, a leading pharmaceutical company located in France. Sentrx and Domes Pharma manufacture products with primary focus on the animal health industry.

SentrX is looking for a Regulatory Affairs Deputy. Under the responsibility of the VP of Quality and Product Development and in collaboration with Group Head of Regulatory Affairs, manage all regulatory aspects for the registration and marketing of the veterinary medicines of the Group in the USA and Ensure that the regulatory activities are compliant to the regulatory requirements for the concerned products category.

Key Responsibilities

• Be the Interface with internal and external (consultants, competent authorities) resources, to understand US (FDA, USDA) regulatory approval requirements
• Prepare and submit, in collaboration with Group regulatory team (either directly or through direct supervision of others) the regulatory documents/applications for new/existing products and determines acceptability of data, procedures, and other product-related documentation presented in support of product registration/variation.
• Responsible, in collaboration with the Dômes Pharma Group regulatory team, for compliance with post-market approval regulatory obligations and maintenance of authorizations for existing products,
• Develop and maintain current regulatory knowledge and keeps abreast of regulatory procedures and changes, interprets regulations, shares regulatory insight, advice and support to other departments.
• Assist the Group regulatory team in analysing US product data, regulatory legislation and providing US specific information.
• Ensure product labelling for all products comply with product dossiers and relevant regulations.

Key Attributes of the Successful Candidate

• Degree in Pharmacy, Chemistry or veterinary Medicine – BS or higher – preferred background in Ophthalmology
• Experience working in Regulatory & Medical Affairs function in Pharmaceutical industry.
• Versed in medical devices, registered drug products and over the counter authorizations
• Experience in Regulatory Affairs for medications.
• Knowledge of CMC activities and requirements.
• Strong communication, organizational, negotiation and interpersonal skills.

Benefits

• Salary commensurate with experience and skills
• Annual bonus potential
• Full benefits package including medical/dental/vision/HSA with generous employer contribution