MSD Regulatory Information Specialist Global Affairs – Operations 

Netherlands, North Brabant 

169269149

Job Description

Purpose of the role

The Regulatory Information Specialistmay involve biological and/or pharmaceutical products).

As a Regulatory Information Specialist you will be working in

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.
• Validatingcompleteness and relevancy of requested data to ensure data integrity and compliancy with external data standards (i.e., SPOR)
• Creatingand 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).
• Leadingimprovement 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
• Excellentcommunication, presentation and interpersonalskills, 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.

Current Contingent Workers apply

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