Global Labelling Strategy Specialist

Why This Role Matters

In the pharmaceutical industry, regulatory labelling is not simply documentation—it is a legally binding communication tool that ensures medicines are used safely and effectively. Product labels and Reference Product Information (RPI) define dosage instructions, safety warnings, contraindications, and risk mitigation strategies that directly impact patient health worldwide.
The Regulatory Labelling Specialist plays a central role in safeguarding compliance with global regulatory authorities while ensuring that product information remains accurate, current, and aligned with evolving scientific evidence. Errors or inconsistencies in labelling can lead to regulatory delays, compliance findings, or patient safety risks.
This role supports the organization’s healthcare mission of improving and prolonging lives by maintaining high regulatory standards across global markets. It is ideal for experienced Regulatory Affairs professionals seeking strategic exposure in labelling lifecycle management within a multinational pharmaceutical environment.

Job Description

The Regulatory Labelling Specialist will be responsible for developing, maintaining, and updating global Reference Product Information (RPI) and ensuring compliance with international pharmaceutical regulations.
The position involves coordinating cross-functional stakeholders, reviewing regulatory labelling content, supporting lifecycle management strategies, and ensuring alignment with global registration requirements. The specialist will also provide strategic input on labelling changes driven by safety updates, regulatory commitments, or business expansion initiatives.
This role requires strong experience in global regulatory affairs, particularly in EU labelling processes, regulatory dossier preparation, and lifecycle management activities.

Key Features of the Role

• Ownership of global Reference Product Information (RPI)
• Regulatory label development and review
• EU labelling process expertise
• Global regulatory dossier exposure
• Lifecycle management and variation handling
• Cross-functional stakeholder coordination
• Risk assessment and mitigation responsibilities
• Strategic regulatory decision-making

Responsibilities

The Regulatory Labelling Specialist will perform the following core duties:
• Create, maintain, and update global Reference Product Information documents
• Develop and review regulatory labels to ensure compliance with global health authority requirements
• Ensure labelling consistency across markets and submissions
• Support regulatory submissions involving labelling updates and variations
• Collaborate with safety, clinical, medical, and commercial teams to incorporate updates into labelling
• Conduct risk assessments related to labelling changes
• Manage lifecycle labelling updates in alignment with regulatory strategies
• Follow up with cross-functional contributors to ensure timely deliverables
• Identify potential regulatory risks and proactively communicate mitigation strategies
• Lead or guide professional employees and support operational managers when required
• Maintain documentation within RIMS and EDMS RA systems
• Utilize MS Office and project management tools for documentation and tracking
• Ensure adherence to agreed timelines and regulatory commitments
• Provide strategic regulatory input while maintaining compliance with EU and global standards

The role requires both operational execution and strategic oversight in regulatory labelling processes.

Required Qualifications

Candidates must meet the educational and professional experience criteria below.

Educational Requirements

• Medical degree, PharmD, or related life sciences discipline
• Minimum MSc or equivalent degree
• Higher degree such as PhD preferred

Strong academic training in medical, pharmaceutical, or regulatory sciences is essential.

Experience and Skills

• 9–10 years of experience in the pharmaceutical industry
• Minimum 5 years of direct labelling experience
• Strong experience in global regulatory affairs and dossier management
• In-depth knowledge of EU regulatory requirements and labelling procedures
• Understanding of regulatory agency structures and submission processes
• Experience with lifecycle management strategies and variations
• Contributor-level experience in RIMS and EDMS RA systems
• Advanced proficiency in MS Office (Word, Excel, PowerPoint, Outlook, MS Project, SharePoint)
• Strong risk assessment and problem-solving capabilities
• Ability to lead professional staff or support operational managers
• Strong communication and stakeholder management skills
• Strategic thinking with understanding of business impact

Candidates must demonstrate both technical regulatory expertise and leadership capability in moderately complex operational environments.

Salary Insights

Compensation for this senior-level regulatory role is aligned with global pharmaceutical industry standards. The package typically reflects the candidate’s depth of experience in labelling, lifecycle management, and EU regulatory compliance.
In addition to competitive salary, employees may benefit from structured performance evaluation systems, global mobility opportunities, and professional development programs.

Company Overview

Merck KGaA operates globally across Healthcare, Life Science, and Electronics sectors. Under its Healthcare division, the company develops innovative medicines and technologies in therapeutic areas such as Oncology, Neurology, and Fertility.
With teams working across six continents, the organization emphasizes scientific excellence, innovation, and patient-centered solutions. Its regulatory teams ensure that medicines meet the highest safety and compliance standards in global markets.
The company fosters an inclusive, diverse, and flexible work culture, encouraging professional growth, collaboration, and long-term career development. Employees are empowered to contribute to meaningful scientific progress while maintaining strong ethical and regulatory standards.

FAQs

1. Is labelling experience mandatory?
   Yes, a minimum of 5 years of direct labelling experience is required.

2. Is EU regulatory knowledge necessary?
   Yes, thorough understanding of EU regulatory requirements and labelling processes is essential.

3. Does this role involve global regulatory submissions?
   Yes, the position supports global dossier management and lifecycle updates.

4. Is leadership experience required?
   Yes, the role may involve guiding professional employees or supporting managers.

5. Are RIMS and EDMS systems required?
   Contributor-level experience in RA systems is expected.

6. What therapeutic areas does the healthcare division cover?
   Oncology, Neurology, Fertility, and other key therapeutic areas.

Application Tips

• Highlight your global labelling and lifecycle management experience
• Mention specific EU labelling projects handled
• Showcase regulatory submission and variation management exposure
• Include experience with RIMS and EDMS systems
• Demonstrate cross-functional coordination examples
• Emphasize risk assessment and regulatory strategy involvement