Veterinary Regulatory Affairs Specialist EU

Job content

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 Veterinary Regulatory Affairs Specialist EU is an integral part of our Regulatory Affairs team based out of our Remote Europe, Belgium - Wavre site.

Position Details

Veterinary Regulatory Affairs Specialist

Location:

Predominantly remote working (home-based), with some European and International travel

when required.

Key requirements:

• Detailed knowledge and understanding of the EU and International Veterinary Medicines
  

regulatory framework.

• Strong technical expertise in product quality/safety/efficacy (able to understand, critique
  

and present information in a format appropriate to the audience)

• Previous experiences with vaccines developed by biotechnological processes such as
  

recombinant DNA technology and controlled gene expression.

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.

• Provide regulatory guidance in relation to new product development when needed
  

(including review of study protocols and reports). Draft requests for scientific advice.

• Provide regulatory guidance in relation to technical transfer of manufacturing operations
  

between sites.

• Review and critique documentation intended for regulatory submissions to ensure relevant
  

regulatory requirements are met.

• Compile and draft registration dossiers suitable for global markets.
• Lead assigned projects to obtain and maintain licenses.
• Support all types of product lifecycle activities (draft and compile renewals, variations, post
  

authorisation commitments etc.).

• Draft responses to questions raised by regulatory authorities.
  

Education & Experience:

• Minimum of a Bachelor’s degree in a relevant scientific or veterinary discipline, but higher
  

degree preferred.

• Ideally at least five years’ experience as Regulatory Affairs in the Biology and vaccines
  

field.

• Proficient in written and spoken English. Additional language skills are a plus.
• Experience with veterinary vaccines (and products derived using rDNA technology) is
  

preferred.

Personal attributes:

• Self-starter, takes initiative.
• Team player essential – the work will involve close collaboration with RA colleagues and
  

other business units.

• Ability to handle several projects simultaneously.
• Good organisational, prioritisation and time management skills. Can work effectively under
  

pressure.

• Excellent attention to detail.
• Proactive: identify regulatory risks and propose solutions.
• Demonstrate integrity.
• Confident in communicating with regulators
  

Opportunities:

Scope for progress within the company over the longer term

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: Remote Europe, Belgium - Wavre

Work Schedule: Monday - Friday (38 Hours)