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Abbott - Manager - Regulatory Affairs - Submission Publishing

Abbott - Manager - Regulatory Affairs - Submission Publishing

Abbott Healthcare Pvt. Ltd.Mumbai, India
30+ days ago
Job description

Job role : Manager Publishing

Job Summary :

We are seeking an experienced and proactive leader to head our Submission Publishing team. The ideal candidate will be responsible for delivering high-quality regulatory submissions while ensuring compliance with global health authority requirements. This role involves managing a high-performing team, optimizing processes, troubleshooting technical issues, and collaborating with cross-functional stakeholders to drive operational excellence.

Key Responsibilities :

Team Leadership & Operations

  • Lead and mentor a high-performing team of submission publishers.
  • Manage workload vs. resource allocation to ensure optimal team productivity and efficiency.
  • Oversee the publishing workflow to ensure timely and compliant submission delivery.
  • Conduct regular performance evaluations and support career development plans.
  • Lead hiring and onboarding of new talent.

Regulatory Submission Management

  • Ensure submission quality by resolving publishing challenges and guiding the team in troubleshooting.
  • Drive a First-Time-Right approach by educating the team and upstream workstreams on regulatory and publishing requirements.
  • Monitor regulatory requirements across regions and ensure team adaptation and compliance.
  • Actively participate in testing and documenting new tool upgrades or Collaboration & Stakeholder Management
  • Collaborate with Regulatory Affairs, Affiliates, and Regional Leads to resolve submission gaps and drive alignment.
  • Participate in eCTD kick-off meetings and contribute to discussions around implementation in new markets.
  • Optimize cost by identifying user-related errors before raising IT support tickets.
  • Work closely with tool vendors (e.g., ArisG) to address technical publishing tool-related queries and contribute to feature development.

    • Training & Development

  • Conduct Train-the-Trainer programs and ensure end-user training for publishing systems.
  • Serve as Subject Matter Expert (SME) across pharma and vaccine product lines.
  • Develop simplified SOPs and process documentation for team reference.
  • Build team competencies through regular knowledge sharing and capability-building sessions.

    • Technical Competencies & Expertise :

  • Strong expertise in eCTD concepts, publishing standards, and troubleshooting.
  • Hands-on experience with publishing tools; ability to identify white spaces and suggest improvements.
  • Understanding of regional regulatory requirements especially RoW (EM), EU, and US markets.
  • Proven experience in Regulatory Operations, including both technical and strategic aspects.
  • Demonstrated ability to drive process improvements and efficiency initiatives.

    • Qualifications & Experience :

  • Bachelor's / Masters degree
  • 1012 years of experience in Regulatory Affairs or Submission Publishing.
  • Minimum 56 years of experience in managing teams and leading regulatory operations.
  • Strong interpersonal, communication

    • (ref : iimjobs.com)

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