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Sr. Associate: Labeling

4-6 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

Sr. Associate: Labeling

LOCATION: India - Hyderabad
WORK LOCATION TYPE: On Site
DATE POSTED: Feb. 02, 2025
CATEGORY: Regulatory


Job Title: Senior Associate, Labeling Compliance

Overview:
In this pivotal role, you will support the planning, coordination, and execution of global labeling compliance initiatives within the Regulatory Affairs department. Working in a fast-paced, matrixed environment with no direct reports, you will collaborate extensively with cross-functional and regional teams—including Regulatory Affairs, Quality, Operations, and Supply Chain—to ensure that labeling meets all global regulatory requirements and maintains the highest standards of quality. This position offers a unique opportunity to lead initiatives, contribute to strategic projects, and drive continuous improvement, all while building strong partnerships across the organization.


Key Responsibilities:

  1. Labeling Strategy and Execution

    • Coordinate day-to-day labeling activities, ensuring timely updates and compliance with global regulatory requirements.

    • Serve as a key contact for cross-functional teams, providing operational support and guidance on labeling procedures, formats, and timelines.

    • Execute labeling change requests, track progress, and maintain accurate documentation in labeling management systems.

  2. Cross-functional Collaboration in a Matrix Organization

    • Collaborate with global and regional stakeholders (Regulatory Affairs, Quality, Operations, Supply Chain) to streamline labeling processes and ensure alignment across multiple time zones.

    • Identify and escalate potential compliance risks or delays in labeling updates, partnering with relevant teams to resolve issues efficiently.

    • Proactively engage with global affiliates to gather requirements, clarify expectations, and facilitate smooth implementation of labeling changes.

  3. Process Improvement and Compliance

    • Contribute to continuous improvement initiatives, optimizing labeling processes, templates, and workflows to enhance efficiency and compliance.

    • Support the maintenance of inspection readiness by ensuring that documentation, SOPs, and labeling processes adhere to quality standards and internal policies.

    • Collect and analyze data on labeling operations, recommending improvements to enhance transparency, speed, and accuracy.

  4. Stakeholder and Vendor Coordination

    • Collaborate with vendors involved in labeling activities (e.g., translation services, artwork vendors) to ensure they meet quality and timeline requirements.

    • Assist in monitoring vendor performance against established SLAs, promptly highlighting any gaps or issues to internal partners.

    • Participate in regular meetings with internal and external partners to align on project deliverables, address operational challenges, and drive timely completion of milestones.

  5. Training and Knowledge Sharing

    • Provide guidance and operational support to junior staff and peers on labeling compliance processes, best practices, and quality standards.

    • Help develop or refine training materials and job aids, promoting consistent understanding and application of labeling procedures across teams.

    • Stay updated on emerging regulatory requirements and industry trends, sharing insights that could impact labeling strategies and practices.


Basic Qualifications:

  • Doctorate degree OR

  • Master’s degree and 2 to 4 years of directly related experience OR

  • Bachelor’s degree and 4 to 6 years of directly related experience OR

  • Diploma and 8 to 10 years of directly related experience

  • Equivalent combinations of education and experience may be considered.


Preferred Qualifications:

  • Experience working with labeling management systems (e.g., Veeva Vault) or other document management platforms.

  • Familiarity with global labeling regulations and end-to-end labeling processes.

  • Demonstrated ability to plan and manage projects in a matrix organization, meeting deadlines and handling multiple tasks effectively.

  • Strong collaboration and communication skills, comfortable working with international teams across time zones.

  • Proven problem-solving capabilities, with an analytical mindset and attention to detail.

  • Experience in vendor coordination, ensuring quality and compliance with established metrics.