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.
- Strong attention to detail and ability to work under tight timelines.
- Good communication and team collaboration skills.
- Proficiency in MS Office applications and Adobe Acrobat for document handling.
Travel Estimate
Low
Job Requirements
Educational Qualification
Master’s degree in Pharmacy (M.Pharm) or Life Sciences
Experience
3-5+ years in regulatory publishing experience
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).
