Regulatory Information Specialist, Global Regulatory Affairs – Operations

Job Description

Join our dynamic Global Regulatory Affairs Operations team, where your expertise can make a real difference in Animal Health!

We are seeking a Regulatory Information Specialist - Operations to help us navigate the complexities of regulatory information management.

Welcome in our team

Global Regulatory Affairs Operations consists of 48 employees and is part of Global Regulatory Affairs Animal Health (AH). This department has 3 teams (Information management, Labeling and Dossier building) and is responsible for the management of regulatory information including planning, organizing, structuring, processing, reporting, archiving and ensuring compliance of information related to regulatory files, product artwork or regulatory status of the AH product portfolio worldwide.

Purpose of the role

The Regulatory Information Specialist - Operations (RIS) is part of the Information management team which consists of 14 employees. The RIS acts as a liaison within the Global Regulatory Affairs department ( this may involve biological and/or pharmaceutical products).

As a Regulatory Information Specialist you will be working in highly collaborative teams and help to determine the impact of changes on regulatory procedures. You will translate the regulatory strategy into tangible system actions, ensure high data quality and manage regulatory submissions.

Tasks and responsibilities include, but are not limited to :

• Responsibility for implementing and maintaining data quality (meta data and master data) in Alexx (Veeva Vault Regulatory Information Management System (RIM)) related to regulatory procedures and submissions.
• Validat ing completeness and relevancy of requested data to ensure data integrity and compliancy with external data standards (i.e., SPOR)
• Creat ing and maintaining Object records and handling workflows in Alexx Registrations
• Submitting in alignment with company change strategy
• Performing actions in defined external regulatory systems, identify and create proposals for system or process improvements in collaboration with cross-functional stakeholders and conduct User Acceptance tests (UATs).
• Lead ing improvement projects
• Maintaining and creating up to date training materials. Provide training, presentations, and communication
• Act as a Subject Matter Expert for Alexx Registrations to GRA and non-GRA users

Your Profile

• Bachelor degree or proven related working experience in Life Sciences (e.g. pharmacy, biology, chemistry, biochemistry, supply chain), MSc is preferred
• Minimum of 3 years of experience in the pharmaceutical industry with a strong understanding of regulatory procedures and/or data/document management
• Working experience with regulatory information systems and platforms (e.g., Veeva Vault)
• Working experience with registration processes (e.g., document management lifecycle including reporting, archiving and regulatory procedures)
• Preferred green belt certified
• Proficient in the English language both written and oral
• Accurate, efficient, pragmatic, flexible, service- and compliance minded
• Excellent communication, presentation and interpersonal skills, ability to interpret and explain (complex) information
• Good team-player skills

What we offer

We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive and the summary below will give you an idea of what you can expect.

• Competitive salary and a 3% year-end bonus;
• 35,5 days of leave;
• Attractive collective health care insurance package with considerable reduction rates;
• Solid Pension Plan;
• Incentive Plan;
• Travel allowance for commuting;
• Numerous training, coaching and e-learning modules for long term job opportunities and development.

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.

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:

01/15/2025

*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: R326267