Regulatory Affairs Manager

Phibro seeking a Regulatory Affairs Manager – Countries Liaison & Operations support.

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 more than $820 million and are supported by over 1500 employees worldwide.

The Regulatory Affairs Manager is an integral part of the Global Regulatory Affairs team.

Reporting to the Regulatory Affairs Director, you will lead and advice on the regulatory affairs strategy for our Animal Health vaccines range and hands on activity. This ranges from new product licenses to lifecycle activities and have oversight on all regulatory aspects of the application, follow up on the implementation of the registration plans in respect of the timelines.

You will maintain an up-to-date regulatory status of ongoing regulatory activities and procedures worldwide.

You will collaborate closely with other key Regulatory affairs stakeholders, including Regulatory affairs technical team and Regulatory Affiliates. You will establish strong relationship with Phibro’s affiliates worldwide and distributors partners and serve as regulatory affairs point perform for knowledge and documents support for them to achieve timely submission, approval and maintaining existing licenses in line with local requirements.

The person is in this role will have a good understanding of the regulatory environment leveraging internal knowledge and external regulatory intelligence.

Responsible of the maintenance of the labelling to support regulatory submissions and new launches or other post licensing activities.

Liaise with manufacturing and other parties as appropriate to ensure updates of the product packaging components are implemented in line with approved labelling and regulatory timelines.

May participate and lead collaboration efforts cross functional in process improvement initiatives.

Will use internal electronic systems for planning, preparing, tracking, and storing submission.

Keep up to date with changes affecting the regulatory environment and inform the impact of those changes to the relevant functions.

Requirements:

• Degree in Life Science (e.g., veterinary medicine, pharmacist, biologist)
• At least 10 years of relevant work experience (Pharmaceutical industry, Animal Health, Regulatory Affairs, International Regulatory environment)
• Knowledge of the regulatory business environment.
• Very good knowledge of English.
• Demonstrated leadership, effective communicator with excellent negotiation skills and the ability to form productive working relationships at all levels across the organization and nationalities.
• Strong team player able to drive change.
• Decision maker with a high degree of initiative, commitment, and persistence.