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Associate Director Regulatory Affairs

2 months ago

Teaneck Township, United States PHIBRO ANIMAL HEALTH CORP Full time

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About Phibro Animal Health Corporation

Phibro Animal Health Corporationis a publicly traded organization with a rich history spanning nearly 100 years of service. The Company is a global manufacturer of medicated feed additives, feed ingredients, advanced nutrition solutions, vaccines and specialty chemicals for various industrial markets. Phibro’s revenues are in excess of $820 million, and are supported by over 1500 employees worldwide.

The Associate Director Regulatory Affairs is an integral part of our Regulatory Affairs team based out of our US - Teaneck, NJ site.

The Associate Director/Director plays a key role in developing and executing regulatory strategies and ensuring compliance with regulatory requirements that govern the development, registration and commercialization of livestock and poultry products (primarily medicated feed additives and water-soluble products) to support the growth and success of our animal health portfolio. The Associate Director/Director will be responsible for preparing and making submissions to F ood and Drug Administration Center for Veterinary Medicine (FDA-CVM), and Health Canada’s Veterinary Drugs Directorate (VDD) and developing and maintaining a core dossier and associated documentation to support global registrations. This role will work cross functionally with other areas within Phibro and with global affiliates. This role will be expected to mentor and develop junior regulatory members and foster a culture of excellence, integrity, collaboration and creativity.

This position can be considered remote for the right candidate.

Key Responsibilities
  • Regulatory Strategy Development: Lead the development and implementation of regulatory strategies aligning with business priorities and regulatory standards. Problem solve and develop strategies for complex regulatory challenges.
  • Regulatory Submission Management: Oversee, prepare, review and submit regulatory documents to CVM and VDD and other global governmental agencies, ensuring accuracy, completeness and compliance with regulations and guidelines. Submits and coordinate documents for legalization to support registration activities in international markets.
  • Government Agency Interactions: Represent the company in both formal and informal interactions with regulatory agencies.
  • Regulatory Compliance/Intelligence Oversight: Monitor regulatory developments and stay abreast of industry best practices in the animal health industry and assess their impact on the registration process and existing registrations and provide strategic guidance to ensure ongoing compliance with regulatory requirements. Participation in industry working groups is expected.
  • Regulatory Document Management: Utilize company systems to maintain current and complete documentation for animal health products including submissions, correspondence, registration details, and labeling. Champion use of these tools within the team and globally.
  • Label Approval and Coordination: Review and approve labeling and submit to CVM/VDD; coordinate labeling reviews internationally.
  • Promotional Material Review: Work cross-functionally with legal, marketing, technical managers, and local RA manager to ensure promotional material is compliant with regulatory guidelines while meeting business needs.
  • Regulatory Process Development and Improvement: Develop regulatory processes to ensure consistency in common tasks and champion use of these processes within the team and globally.
Interpersonal Skills / Communication

Prioritizing and Organizing Work

Managing Time

Demonstrating Initiative

Skills

Interpersonal skills sufficient to communicate verbally and in writing with others in an objective and cooperative manner.

Advanced organizational skills.

High degree of time management skills and ability to handle multiple priorities and projects at once.

Extremely high level of attention to detail and high standard of quality.

Must be accurate, detail-oriented and thorough.

Ability to work independently.

Demonstrated resourcefulness and initiative

A motivated self-starter, work well in groups and demonstrate excellent customer service.

Must be proficient using Email, phones, cell phones, and office equipment.

Proficiency in Microsoft Office Products

Education & Experience
  • Bachelor’s degree, preferably in a scientific field or animal health with 8+ years of work experience in regulatory affairs. Direct experience working in animal health regulatory affairs required.
  • Knowledge of global regulatory requirements and guidelines for medicated feed additives and veterinary pharmaceuticals including FDA's CVM and VDD/Health Canada regulations guidelines; experience with regulatory submissions in multiple regions and knowledge of EMA and EFSA regulated products is highly desirable.
  • Knowledge of using e-Submitter/Web Trader is required and REP for submissions to VDD desirable.
  • Knowledge of preparing dossier in non-eCTD, CTD, and VneeS format is preferred.
  • Proven track record of successful regulatory submissions and approvals.

Phibro is an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, gender identity, veteran status, marital status or any other characteristics protected by law.

Business Unit: Animal Health & Mineral Nutrition
Division: Animal Health & Nutrition 
Department: Regulatory Affairs 
Location: US - Teaneck, NJ 
Work Schedule: Monday - Friday (Standard Work hours) 
Weekly Working Hours: 40.00 

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