Regulatory Affairs Manager

2 days ago

Reading, United Kingdom CV-Library Full time

The Role

This newly established global position is critical to ensuring compliance with all relevant regulations related to the production, distribution, and marketing of our clients’ veterinary diagnostic products. As the Regulatory Affairs Manager, you will play a key role in shaping and implementing a regulatory strategy that aligns with our business goals and growth trajectory.

The role is based at their UK site in Berkshire and is a member of the UK site leadership team, working closely with Business Unit Management in The Netherlands. Previous experience with licensing products and facilities through the USDA is highly desirable.

Key Responsibilities

The essential responsibilities of the role include, but are not limited to:

  1. Regulatory Strategy:
    Develop and execute a regulatory strategy to support the registration of products and facilities in line with applicable regulatory requirements.
    Ensure all company products comply with the regulatory standards in regions where we develop, manufacture, and distribute.
  2. Regulatory Compliance and Approvals:
    Lead global regulatory submission and approval processes with key agencies, including but not limited to USDA, FLI, and MAPA.
    Maintain strong relationships with regulatory authorities to benefit the business.
  3. Regulatory Intelligence:
    Stay informed about current and pending regulations in veterinary diagnostics, with a strong focus on the EU and USA.
    Conduct regulatory intelligence to advocate for company interests with regulatory bodies and industry associations.
  4. Lifecycle Management:
    Ensure ongoing compliance of products throughout their lifecycle by monitoring regulatory changes and assessing potential impacts.
    Verify product labeling for accuracy and regulatory conformity.
  5. Support and Training:
    Provide regulatory advice and training to internal departments.
    Serve as a key resource on regulatory matters across the organization.

Qualifications

Required Experience and Education:
7-10 years of experience in regulatory affairs within a similar business environment.
Proven track record in licensing veterinary products, particularly with the USDA.
Experience developing regulatory strategies in a growing business.
Degree in Veterinary Medicine (DVM) or equivalent is advantageous.

Skills and Competencies:
Expert in interpreting regulatory requirements and determining compliance strategies.
Exceptional written and verbal communication skills, with the ability to deliver complex information to diverse audiences.
Strong organizational and time-management skills, with the ability to handle multiple tasks simultaneously and with a high level of attention to detail.
Team-oriented mindset; capable of collaborating with global teams to achieve objectives.
Proficient in Microsoft Office tools.
Flexible and adaptable, with innovative problem-solving abilities.

Travel Requirements:
Up to 10% travel may be required.

What We’re Looking For
We are seeking a proactive and driven individual with deep expertise in veterinary regulatory affairs, particularly within diagnostics. If you thrive in a dynamic environment, have a passion for ensuring compliance, and can build strong regulatory strategies that drive business success, we encourage you to apply.

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