Global Excellence Lead (Regulatory Affairs)

Job Description

Key role in driving the advancement of Global Regulatory Affairs

For our Animal Health location Boxmeer, we are currently recruiting a Global Excellence Lead (Regulatory Affairs)

Welcome to our team

As part of our Animal Health Research & Development organization, our Global Regulatory Affairs (GRA) department (~77 employees in two teams; one in NL and one in the US) is responsible for licensing of new biologicals and the regulatory maintenance of licensed biologicals. Our team in NL also manages the operational aspects of regulatory information systems and processes for the entire Animal Health portfolio. The newly formed Global Excellence team in Boxmeer has project and portfolio management responsibilities supporting the business and operations, provides dedicated support to the GRA teams and leads or contributes to strategic initiatives like Enhanced Project Delivery, Process Efficiency and Strengthened Collaboration. To lead this team and drive Excellence in GRA, we are looking for a Global Excellence Lead (Regulatory Affairs).

Purpose of the role

Reporting into the Executive Director GRA, and as part of the GRA Leadership Team, you are responsible for implementing mature portfolio and project management practices, enhancing collaboration and promoting the sharing of best practices. You will oversee the GRA Excellence team (3 employees) and lead the management of global compliance and regulatory projects, ensuring high standards in project execution, planning, resource allocation, budgeting and stakeholder communication. Your responsibilities also include overseeing the project portfolio and prioritization and drive towards a comprehensive regulatory intelligence database. Leveraging your expertise, you will lead continuous improvements in both internal and external processes, streamline regulatory document management, and contribute to broader GRA initiatives. Additionally, you will support the Regulatory Strategy Team in managing priority projects, collaborate with cross-functional teams (e.g., R&D, Manufacturing, Quality, and Science & Technology), and expertly navigate regulatory frameworks, particularly in non-EU/US markets.

Your profile

• Academic degree in biomedical Sciences (e.g., virology, bacteriology, molecular biology, veterinary sciences).
• Extensive and relevant experience in the (veterinary) pharmaceutical industry in the development and/or maintenance of products, and in regulatory affairs, preferably in the field of biologicals.
• Excellent project- and change management skills & proven ability to manage challenging projects in a complex matrix organization.
• Strong problem-solving and decision-making abilities.
• Ability to think Out-of-the-Box and challenge status quo with a continuous improvement mindset.
• Excellent command of the English language.

What we offer

A new position with impact, offering the opportunity to contribute to our success as this new team will facilitate cross-functional alignment, enhance collaboration, and align with our dedication and commitment to Excellence. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.

• Competitive salary.

• 25 days of leave.
• Company car.
• Bonus Plan subject to the company annual results.
• Incentive Plan.
• Solid Pension Plan.

Animal Health

Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and performance of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society, and our planet.

Through our commitment to The Science of Healthier Animals®, we offer veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally connected identification, traceability and monitoring products. We invest in dynamic and comprehensive R&D resources and a modern, global supply chain. We are present in more than 50 countries, while our products are available in some 150 markets.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

For questions about this vacancy

Please send an email including the vacancy number and job title to the following email address: RecruitmentNL@MSD.com

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

10/4/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date: 10/04/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R310555