POSITION SUMMARY
The Senior Regulatory Affairs Specialist will be responsible for managing the Tullamore site regulatory program and coordinating all regulatory activates for the site. The individual will work with a cross-functional team to manage and coordinate regulatory activities and strategies for several global markets. This individual will liaise between the site and Zoetis global regulatory affairs and work closely with the regulatory affairs team and in-country regulatory affairs managers on ensuring appropriate documentation is provided for all regulatory submissions including renewals, queries, variations/submissions and new market introductions. This position will also support Quality System activities as required by the business.
POSITION RESPONSIBILITIES
· Be responsible for retrieving data from site quality systems (Veeva Vault, ETS, central database repositories etc).
· Use strong organization & planning skills and demonstrate proficiency in Zoetis regulatory systems to track and communicate the status of regulatory submissions and approvals.
· Review regulatory documents for accuracy, compliance, review and approve site change control, regulatory compliance reviews and other site documents as required.
· Have good communication skills and be able to partner with multiple site colleagues to assist in the collation, review, presentation of data and coordination of data for regulatory submissions.
· Be responsible for the timely submission of regulatory changes to support site goals that impact the business.
· Liaise with regulatory affairs colleagues across global regions regarding dossiers, regulations and commitments.
· Assume responsibility as the compliance network member for regulatory assessment of all site change controls.
· Provide quality system support on quality and compliance activities as required.
· Demonstrate the ability to problem solve as well as provide risk-mitigation solutions for regulatory strategies.
· Provide regulatory updates and notifications to the site on a regular basis.
· This individual may lead site projects and initiatives.
ORGANIZATIONAL RELATIONSHIPS
Working closely with multiple internal and external groups for fast-moving projects to ensure proper and timely communication.
EDUCATION AND EXPERIENCE
· Minimum BSc in Chemistry, Engineering, Microbiology, or another technical field.
· Five or more years of relevant experience is required. Regulatory or quality professional experience is preferred.
TECHNICAL SKILLS REQUIREMENTS
· A strong understanding of regulatory guidance documents and directives is required as well as an understanding of pharmaceutical manufacturing cGMP requirements including aseptic processing.
· This individual will need to understand regulatory dossier requirements for all regions to complete regulatory assessments and filing as required.
· Excellent oral and written communication skills. Able to independently write logical and succinct technical communications.
· Attention to detail and organizational skills required
· Demonstrated ability to problem solve and use scientific reasoning to provide solutions
· Individual must be self-motivated and be able to work independently while managing the program
· Strong computer skills including Microsoft Office
· Project management experience is preferred
PHYSICAL POSITION REQUIREMENTS
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This is a hybrid role.
About Zoetis
At Zoetis, our purpose is to nurture the world and humankind by advancing care for animals. As a Fortune 500 company and the world leader in animal health, we discover, develop, manufacture and commercialize vaccines, medicines, diagnostics and other technologies for companion animals and livestock. We know our people drive our success. Our award-winning culture, built around our Core Beliefs, focuses on our colleagues' careers, connection and support. We offer competitive healthcare and retirement savings benefits, along with an array of benefits, policies and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources.
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