Regulatory Operations Specialists - II (Associate)

Regulatory Operations Specialists

• II (Associate) Job ID: 24-03365

Qualifications:

Education Requirements:

• Bachelor's degree in a relevant discipline such as animal science, veterinary technology, immunology, toxicology/pharmacology, chemistry, biology, business, regulatory or law

• OR-

• Master's degree in a relevant discipline

Required Experience and Skills:

• Regulatory and/or product development experience

• Strong written and oral communication skills

• Excellent people, communication and leadership skills

• Must be proactive, organized, able to manage time effectively, and pay attention to detail.

Preferred Experience and Skills:

• Prior animal health regulatory experience

• Knowledge of animal health product development

• Knowledge and understanding of the animal health sector.

ADDITIONAL: Will work onsite 3 days (Tuesday / Wednesday required), and 2 days remote.

Responsibilities:

The specialist position is responsible for maintaining the US pharma products registrations and providing CVM/FDA support for labeling and chemistry, manufacturing, and controls (CMC) submissions.

The specialist position also works as part of a team to prepare and submit marketed product reports to the regulatory authorities; maintains US state registrations, labeling, drug listings; the registration database; and the veterinary compendium; obtains US Free Sales Certificates.

The specialist may lead/support teams on various regulatory topics; optimize procedures, processes, and infrastructure; and assist with document management and archiving as necessary.

The specialist provides regular updates to management and escalates issues.

MAJOR ACTIVITIES AND RESPONSIBILITIES:

With the support and guidance of the Executive Director of US Regulatory Affairs, the Specialist has the following main responsibilities: Drug Listings - • Maintain and update drug listings for new marketed US Pharmaceutical products (including but not limited to establishment registrations for which we are US Agents, listing and delisting products, and updating product labels for the DailyMed) • As needed, act as liaison with internal colleagues or CVM to resolve any drug listing related issues • Responsible for updating SOP and CVM's Annual Product Verification Report • Responsible for updating payment agreement between Single Source and Intervet Inc. Submission Support - • Support the Global RA CMC team by packaging and submitting (via eSubmitter) MCSRs and Supplements to CVM. • Track any CVM correspondence on these submissions in the Regulatory Task Tracking (RTT) system and work with appropriate managers to resolve any issues. • Interface with project managers and regulatory project managers about routine and non-routine submissions to ensure due dates are met. • Perform regulatory information management tasks including file transfer, storing, tracking, and archiving of regulatory submission documents/correspondence into RA SharePoint site and/or ALEXX. • Provide eSubmitter support as contact point for eSubmitter issues. May assist IT in user acceptance testing of new versions of eSubmitter. CARES Act Reporting - the annual amount of listed animal drugs that an establishment manufactured, prepared, propagated, compounded, or processed (including repacking and relabeling) for commercial distribution must be reported on an annually. Work with supply chain to get amounts, update reports and submit through NextGen Portal. As needed, obtain, and provide routine documentation to support regulatory compliance for products sold domestically and internationally, such as US Free Sales Certificates for US pharmaceutical products. Other tasks or projects, as needed.

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