Senior Specialist - Regulatory Affairs

Job Description

SUMMARY OF POSITION

This position is responsible for ensuring regulatory filings of animal health products in pursuance of licensure and marketed animal health products are submitted in compliance with applicable USDA regulations and is within the Global Regulatory Affairs Bio team. This position is based in the US however closely working together with the GRA team located in the EU. In this role, you participate in cross functional teams on maintenance of our products to provide support/drive filings for marketed animal health products in compliance with applicable USDA regulations and regulations for relevant export regions.

MAJOR ACTIVITIES AND RESPONSIBILITIES

All major activities and responsibilities below would approximate 100% of time spent in the role, where applicable. Individual activities and responsibilities listed below may fluctuate beyond > 25% of time spent depending on company needs.

• When proficient in the job role, provide USDA regulatory guidance and regulatory strategy with interdepartmental teams for pre and post license of US Biologicals.

  • Additionally, may assist as an Alternate Liaison with the USDA for pre or post-regulatory responsibilities to include submissions and communications with the USDA, internal MAH departments or international permittees, where applicable.

  • May serve as subject matter expert in regulatory matter(s), such as but not limited to labeling, facility documents, relative Potency assays, antigen overages, licensure processes, permits, ingredients of animal origin and ensure that these meet the requirements of the USDA and export markets.

  • Develops and maintains profound knowledge of all relevant regulatory requirements.

  • Travel (≥ 10%) might be needed.

JOB DESCRIPTION

• Review, prepare and communicate regulatory submissions in support of new licenses or licensed biologicals with the USDA (Examples of submission include but not limited to label packaging, reports/protocols/raw data, individual study summaries (ISS), outlines of production and special outlines). Alternatively, may review and prepare registration documents for export markets.

• May serve as point of contact for GRA internation dossier/registration questions for new submissions, renewals and variations for US biologicals filed with local CORA, where applicable. Additionally, may lead in creation of GRA standard international dossiers for US Biologicals.

• May review market advertising and promotions (A&P) for US Biologicals in compliance with USDA regulations and product license filings, including but not limited to technical bulletins, journal articles, presentations, routine A&P.

• May prepare and maintain regulatory documents and communications regarding US biological restricted products with US state veterinarians for approval and compliance. Support state registrations for US Biologicals, when applicable.

Required experience and skills:

• Bachelor’s degree with a minimum of 5 years of regulatory experience, or Master’s degree with a minimum of 3 years of regulatory experience in the vaccine industry.

• Minimum of (regulatory) experience within the (veterinary) pharmaceutical industry (preferable biologicals).

• Preferred working knowledge of USDA requirements and regulations relating to manufacturing of biological vaccines. Excellent time and project management skills. Excellent people, communication, leadership skills and well-developed cultural awareness for involvement with cross departmental teams.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As