Junior Submission Publisher

4 weeks ago

Gurugram, India SUN PHARMA Full time

Title:

Junior Submission Publisher

Business Unit:

Regulatory Operations – Global Regulatory & Business Continuity – Innovative Medicines

Job Grade

Senior Executive / G11B

Location :

Mumbai (preferred) / Gurugram / Vadodara

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.”

Position Summary –

Job Purpose

The Junior Submission Publisher will be responsible for assisting in the compilation, formatting, publishing, and validation of regulatory submissions in eCTD and non-eCTD formats . The role will provide exposure to global regulatory submission requirements for agencies such as US FDA, EMA, Health Canada, MHRA , and others.

Key Responsibilities

• Assist in publishing regulatory submissions (NDA, ANDA, BLA, MAA, variations, supplements, IND, DMF , etc.) in eCTD and NeeS formats.

• Support preparation of submission-ready documents by ensuring compliance with global health authority specifications and internal publishing standards.

• Perform document formatting, bookmarking, and hyperlinking in accordance with agency requirements.

• Execute validation checks using publishing tools to ensure submissions are compliant (no validation errors).

• Assist in timely delivery of submissions to global health authorities through electronic gateways (e.g., ESG for FDA, CESP for EMA, etc.).

• Maintain archival and version control of submission packages in regulatory systems.

• Collaborate with regulatory operations leads, submission managers, and medical writers to ensure smooth publishing workflows.

• Support troubleshooting and resolution of technical issues in submission files.

• Stay updated with changes in eCTD specifications, guidance, and publishing tools.

Qualifications & Skills

• M.Pharm (Pharmaceutics / Regulatory Affairs / Pharmaceutical Sciences).

• Basic knowledge of CTD/eCTD structure and global submission requirements.

• Familiarity with publishing tools (e.g., Lorenz DocuBridge, Extedo, Liquent, etc.) is desirable.

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