Regulatory Affairs Associate

Phibro Animal Health; Sligo; On-site; EUR 45,000 - 65,000; Full time

Job summary

A global animal health company located in Sligo is seeking a Regulatory Affairs Associate to provide regulatory support for their veterinary vaccine portfolio. Candidates should have a relevant scientific degree and 3-5 years of regulatory experience in the pharmaceutical industry. Proficiency in English and excellent organizational skills are essential. This position offers a competitive benefits package.

Benefits

Competitive benefits package

Qualifications

• 3-5 years of experience in the international pharmaceutical industry, including regulatory experience.
• Experience with veterinary vaccines and/or products derived using rDNA technology is ideal.

Responsibilities

• Provide regulatory support for veterinary vaccine portfolio.
• Support regulatory aspects of assigned projects based on business strategy.
• Establish relationships with other business units to ensure regulatory perspectives are included.
• Assist with product lifecycle activities and responses to regulatory questions.
• Prepare and organize regulatory submissions for different countries.

Skills

Understanding of international/EU Veterinary Medicines regulatory framework

Regulatory submission procedures in EU

Labelling and artwork management

Proficient in scientific written and spoken English

Organizational and time management skills

Education

Bachelor’s degree in a relevant scientific or veterinary discipline

Job description

About Phibro Animal Health Corporation

Phibro Animal Health Corporation is a publicly traded, global organization with a rich history in animal health and nutrition as a manufacturer and marketer of medicated feed additives, vaccines, nutritional specialty products, and mineral nutrition. We strive to be a trusted partner with livestock producers, farmers, veterinarians, and consumers who raise or care for farm and companion animals by providing solutions to help them maintain and enhance the health of their animals.

Phibro is a diversified company in manufacturing and marketing products for ethanol performance, microbials for plants, home and industrial applications, and specialty chemicals for various industrial markets. In addition to, Phibro’s revenues are in excess of $1 billion and are supported by over 2,300 employees worldwide.

At Phibro, people are our greatest asset. We strive to develop a diverse workforce that fosters an environment where people feel supported in openly sharing their creativity and skills that allows them to be the most successful that they can be.

If you are interested in working for Phibro and feel that you do not meet all qualifications, we encourage you to apply as you might be the right candidate for this role or other positions.

The Regulatory Affairs Associate is an integral part of our Regulatory Affairs team based out of our Ireland - Sligo site.

Position Details

Key requirements:

• Understanding of the international and European Veterinary Medicines regulatory framework and guidelines.
• Understanding of the Regulatory Submission procedures in EU and the international area.
• Understanding of the Labelling and artwork management.

Requirements

Technical knowledge about Veterinary Medicines quality/safety/efficacy requirements.

Responsibilities

• Provide regulatory support for the company’s veterinary vaccine portfolio.
• Support all regulatory aspects of assigned projects in accordance with the business strategy, priorities and timelines.
• Establish and maintain effective working relationships with other PAHC business units (Manufacturing, Quality and Marketing) to ensure regulatory perspectives are incorporated into business plans.
• Supports all types of product lifecycle activities.
• Supports writing responses to questions raised by regulatory authorities.
• Prepare and organize the regulatory package submission to the different countries (international area).

Cross Functions Support

• Supports quality in implementing Regulatory authorities approvals.
• Supports Supply chain with regulatory information on the products.
• Supports CCP process by assessing impact of the changes on existing registrations and implementing the variation process.
• Ensures the Artwork management process is under control, approved artworks are communicated to the right stakeholders on time.

Education & Experience

• Minimum of a bachelor’s degree in a relevant scientific or veterinary discipline.
• At least 3-5 years’ experience in international pharmaceutical industry, including experience in regulatory.
• Ideally experience with veterinary vaccines and/or products derived using rDNA technology.
• Proficient in scientific written and spoken English. Additional language skills are a plus.

Personal Attributes

• Self-starter takes initiative.
• Team player essential.
• Ability to handle several projects simultaneously.
• Good organizational, prioritization and time management skills. Can work effectively under pressure.
• Excellent attention to detail.
• Proactive: identify regulatory risks and propose solutions.
• Demonstrate integrity.

To learn more about Phibro Animal Health’s competitive benefits package, please click here: Phibro Benefits.

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: Ireland - Sligo

Work Schedule: Monday - Friday (40 Hours)