Expert – Regulatory Labelling
Location: Bangalore, Karnataka, India
Function: Regulatory Affairs / Labelling Operations
Job Type: Full-time
Job Overview
We are seeking an experienced Regulatory Labelling Expert to manage and ensure global compliance of pharmaceutical product information and labelling activities. The role involves end-to-end ownership of regulatory labelling processes, reference product information, and lifecycle maintenance of product labels across multiple markets.
This position requires strong expertise in global regulatory affairs, pharmaceutical labelling regulations, and product information management systems, with the ability to collaborate across global regulatory, safety, and medical teams.
Key Responsibilities
Regulatory Labelling Development & Maintenance
Develop, review, and maintain global regulatory product labels and reference product information.
Ensure labelling documents comply with applicable global regulatory requirements and health authority guidelines.
Manage updates to product information throughout the product lifecycle.
Regulatory Compliance & Strategy
Ensure compliance with pharmaceutical laws, regulations, and labelling standards across global markets.
Interpret and implement regulatory requirements from agencies such as EU authorities and other global health agencies.
Support lifecycle management strategies for regulatory labelling documentation.
Cross-functional Coordination
Collaborate with regulatory affairs, pharmacovigilance, medical, and quality teams.
Track deliverables from cross-functional stakeholders and ensure timely completion.
Follow up on inputs required for regulatory labelling submissions and updates.
Documentation & Systems Management
Utilize regulatory systems such as RIMS and EDMS for labelling and document management.
Maintain accurate and up-to-date regulatory records and submission documents.
Ensure proper documentation control in compliance with internal and external standards.
Risk Management & Issue Resolution
Identify potential regulatory risks and implement mitigation strategies.
Escalate issues impacting timelines, compliance, or submission quality.
Support problem-solving for labelling discrepancies or regulatory changes.
Stakeholder Communication
Communicate regulatory labelling updates to internal and external stakeholders.
Provide clear guidance on labelling requirements and regulatory expectations.
Ensure transparency in timelines, risks, and dependencies.
Process Execution & Governance
Execute assigned regulatory labelling tasks independently within defined timelines.
Adhere to established SOPs, regulatory frameworks, and quality standards.
Contribute to continuous improvement of labelling processes and workflows.
Leadership & Mentorship
Guide and support junior regulatory professionals or operational staff.
Contribute to training and knowledge sharing within regulatory labelling teams.
Assist in aligning operational priorities with business needs.
Required Qualifications
Education
Medical degree / PharmD / MSc or equivalent in Life Sciences or related discipline
Higher qualification (PhD or equivalent) is preferred
Experience Required
Fresher Eligible: No
Required Experience: Minimum 9–10 years of experience in pharmaceutical industry, including at least 5 years in regulatory labelling
Required Skills
Regulatory Affairs Expertise
Global Regulatory Labelling
Pharmaceutical Product Information Management
Regulatory Lifecycle Management
EU Regulatory Requirements (strong knowledge required)
Systems & Tools
RIMS (Regulatory Information Management Systems)
EDMS (Electronic Document Management Systems)
MS Office Suite (Advanced proficiency in Word, Excel, PowerPoint)
MS Project, Outlook, SharePoint
Core Competencies
Regulatory Compliance & Strategy
Label Development & Maintenance
Cross-functional Coordination
Risk Assessment & Mitigation
Regulatory Documentation Management
Experience Summary
Minimum 9–10 years in pharmaceutical regulatory affairs
At least 5 years of hands-on regulatory labelling experience required
Strong exposure to global regulatory systems and EU labelling processes
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