Associate Director Regulatory Affairs

Position Details

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 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. 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.

Key Competencies

Interpersonal Skills / CommunicationPrioritizing and Organizing WorkManaging TimeDemonstrating 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 initiativeA 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.
30+ days ago