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Senior Submission Publisher

Senior Submission Publisher

ConfidentialGurgaon / Gurugram, India
5 days ago
Job description

Title :

Senior Submission Publisher

Business Unit :

Regulatory Operations – Global Regulatory & Business Continuity – Innovative Medicines

Job Grade

G10 / Manager

Location :

Mumbai (preferred) / Gurgaon / Baroda

Key Responsibilities

At Sun Pharma, we commit to helping you ' Create your own sunshine '— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine

As you enter the Sun Pharma world, you'll find yourself becoming 'Better every day' through continuous progress. Exhibit self-drive as you 'Take charge' and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we 'Thrive together' and support each other's journeys.'

Job Purpose

The Senior Submission Publisher will lead and oversee the planning, preparation, publishing, and dispatch of regulatory submissions in eCTD and non-eCTD formats to global health authorities. This role not only ensures submission compliance and quality but also provides leadership in workload management, publishing strategy, and adoption of new tools and technologies to streamline the submission process.

Key Responsibilities

Core Publishing

  • Oversee end-to-end publishing activities for major and minor submissions (NDA, ANDA, BLA, MAA, IND, DMF, variations, renewals, supplements).
  • Ensure compliance with global health authority requirements (FDA, EMA, Health Canada, MHRA, TGA, WHO, etc.).
  • Perform document formatting, hyperlinking, bookmarking, and validation using industry-standard publishing tools.
  • Ensure on-time dispatch of submission packages via electronic gateways (e.g., ESG, CESP, MHRA portal).

Quality & Compliance

  • Conduct quality reviews of submissions prepared by junior publishers, ensuring adherence to specifications and eliminating validation errors.
  • Maintain submission archives, version control, and audit-ready documentation.
  • Implement best practices and continuous process improvements to strengthen publishing quality and compliance.

    • Workload & Team Support

  • Manage daily workload distribution within the publishing team to meet timelines.
  • Provide guidance and technical support to junior publishers and new team members.
  • Act as the first point of contact for troubleshooting complex publishing issues.

    • Metrics & Process Improvement

  • Generate and track submission metrics (cycle times, on-time delivery, volume, quality compliance) for management review.
  • Identify opportunities for process optimization and automation within publishing workflows.
  • Support development and refinement of Standard Operating Procedures (SOPs) and work instructions.

    • Technology & Innovation

  • Participate in testing, validation, and implementation of publishing tools version upgrades.
  • Provide feedback to IT and system vendors in enhancing publishing tool functionality.
  • Stay updated on emerging regulatory publishing trends, specifications, and technologies.

    • Qualifications & Skills

  • Master's degree in Pharmacy (M.Pharm) or Life Sciences (preferred).
  • 6–10 years of hands-on regulatory publishing experience in eCTD and non-eCTD formats.
  • Expertise in CTD / eCTD structure, regional specifications, and global submission requirements.
  • Proficiency with industry-leading publishing tools (Lorenz, Liquent, Extedo, Veeva Vault, Amplexor etc.) and validation tools.
  • Strong attention to detail, organizational skills, and ability to manage multiple priorities.
  • Good leadership and team mentoring skills.
  • Excellent written and verbal communication skills.
  • Experience in metrics generation, process improvement, and tool implementation preferred.
  • Experience in RIMS Implementation, Regulatory Data Management and Governance will be an added advantage.

    • Travel Estimate

    Low

    Job Requirements

    Educational Qualification

    Master's degree in Pharmacy (M.Pharm) or Life Sciences

    Experience

    8+ years of hands-on regulatory publishing experience in eCTD and non-eCTD formats.

    Your Success Matters to Us

    At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let's create a brighter future together!

    Disclaimer : The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

    Skills Required

    ectd

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