Regulatory Affairs Associate

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

Job summary

A leading global veterinary health organization in Sligo is seeking an experienced Regulatory Affairs professional. The role involves providing regulatory support for veterinary vaccine portfolios, preparing regulatory submissions, and collaborating with various business units. Candidates should have a bachelor's degree in a scientific discipline and 3-5 years' experience in the international pharmaceutical industry. The company is committed to development and diversity in the workplace.

Qualifications

• Minimum 3-5 years' experience in the international pharmaceutical industry.
• Ideally experience with veterinary vaccines or rDNA technology.
• Additional language skills are a plus.

Responsibilities

• Provide regulatory support for veterinary vaccine portfolio.
• Prepare regulatory package submissions for different countries.
• Support writing responses to regulatory authority inquiries.

Skills

Understanding of veterinary regulatory framework

Technical knowledge of veterinary medicine quality

Organizational skills

Proficiency in English

Education

Bachelor's degree in a relevant scientific field

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.

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.

Responsibilities

• Technical knowledge about Veterinary Medicines quality/safety/efficacy requirements.
• 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 implement 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)