Senior Associate/Manager, Regulatory Affairs

About Phibro Animal Health Corporation

Phibro Animal Health Corporation is 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 Senior Associate/Manager, Regulatory Affairs is an integral part of our Regulatory Affairs team based out of our US - Teaneck, NJ - Remote site.

Position Details

The Senior Regulatory Affairs Associate/Manager plays a key role in 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) while also providing strategic guidance to support the growth and success of our animal health portfolio. The Senior Regulatory Affairs Associate/Manager will be responsible for preparing and making submission to Food 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. All team members are expected to foster a culture of excellence, integrity, collaboration and creativity.

This position can be considered remote for the right candidate.

Key Responsibilities

• Regulatory Strategy Development: Assist with the development and implementation of regulatory strategies aligning with business priorities and regulatory standards.

• 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 associations is supported and encouraged.

• Regulatory Document Management: Utilize company systems to maintain current and complete documentation for animal health products including submissions, correspondence, registration details, and labeling.

• 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, local RA managers to ensure promotional material is compliant with regulatory guidelines while meeting business needs.

• Pharmacovigilance Point of Contact: Serve as a pharmacovigilance point of contact for the United States as part of Phibro's global pharmacovigilance system. Responsibilities will include gathering information needed to complete adverse drug experience reports and to submit the adverse event reports within the required timeframes through the Electronic Submission System (ESS) or the Safety Reporting Portal (SRP).

Key Competencies

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 3 years of work experience in regulatory affairs.

• 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 preparing dossiers in non-eCTD, CTD and VneeS format is desirable.

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 - Remote

Work Schedule: Monday - Friday (Standard Work hours)

Weekly Working Hours: 40.00