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Manager, Labelling

6-8 years
Not Disclosed
10 Feb. 17, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Manager, Labelling

Location: Hyderabad, India
Work Location Type: On-site
Date Posted: February 2, 2025
Category: Regulatory


Job Summary:

The Manager, Labelling will be responsible for coordinating and executing global labeling compliance activities, ensuring adherence to regulatory requirements across multiple regions. This role involves collaboration with cross-functional teams such as Regulatory Affairs, Quality, Clinical, Operations, and Supply Chain to maintain accurate labeling processes, documentation, and systems. The position will serve as a subject matter expert in global labeling standards, driving continuous improvement initiatives and maintaining high-quality standards.


Key Responsibilities:

1. Global Labeling:

  • Coordinate end-to-end labeling changes (updates, reviews, approvals) to ensure compliance with regional and international regulations.

  • Maintain and refine labeling templates, SOPs, and related documentation for consistency and compliance.

2. Cross-Functional Collaboration:

  • Work closely with local, regional, and global teams (Regulatory Affairs, Quality, Supply Chain) to identify labeling requirements and address challenges.

  • Provide expertise on labeling processes and compliance requirements to relevant stakeholders.

3. Planning & Execution:

  • Develop detailed project plans and timelines for labeling initiatives, ensuring timely completion.

  • Monitor progress, identify risks, and implement corrective actions to ensure projects stay on track.

4. Process Improvement & Compliance:

  • Identify opportunities to streamline labeling workflows and enhance process efficiency.

  • Maintain up-to-date records, quality checks, and accurate documentation to support inspection readiness and audits.

5. Technical & Operational Support:

  • Perform critical reviews of artwork, translations, and labeling content to ensure accuracy and regulatory compliance.

  • Troubleshoot labeling system issues, ensuring timely resolution with minimal disruption.

6. Mentoring & Knowledge Sharing:

  • Guide and train junior team members and new hires on labeling standards, tools, and best practices.

  • Foster a culture of continuous learning and knowledge-sharing within the team.


Qualifications:

Basic Qualifications:

  • Doctorate degree, OR

  • Master’s degree with 4 to 6 years of relevant experience, OR

  • Bachelor’s degree with 6 to 8 years of relevant experience, OR

  • Diploma with 10 to 12 years of relevant experience.

Required Qualifications:

  • Proficiency in Labeling Management Systems (e.g., Veeva Vault) and document management tools.

  • Strong knowledge of global regulatory labeling requirements for pharmaceuticals or biologics.

  • Proven experience in project planning and execution, with excellent organizational and problem-solving skills.

  • Excellent communication skills and ability to collaborate in a cross-functional, global environment.

  • Experience with continuous improvement methods to enhance labeling processes.


Soft Skills:

  • Excellent written and oral communication skills with keen attention to detail.

  • Ability to demonstrate leadership in a team environment, involving negotiation, persuasion, collaboration, and analytical judgment.

  • Proficient in time and project management skills.

  • Self-starter with perseverance and determination to achieve results.