Sun Pharma, one of the largest pharmaceutical companies globally, is actively recruiting
Regulatory Operations Publishing Strategy Professionals for its Gurugram location. This opportunity offers an engaging environment where you’ll contribute to global regulatory submissions and compliance.
Job Overview
As part of the regulatory operations team at Sun Pharma, you will be responsible for managing publishing and submission tasks to various regulatory agencies. Your role will involve ensuring submission readiness and maintaining compliance with international regulatory standards for countries like the
US, Australia, Canada, the EU, Japan, and Brazil.
Location: Gurugram, Haryana, India
Job Type: Full-time, On-site
Position Level: Mid-Senior
Job Description
- Perform document level and submission level publishing and dispatching to the Agency
- Perform end-to-end publishing activities
- Perform submission readiness checks
- Publishing documents for CTD, eCTD, Nees submissions for various countries like US, Australia, Canada, EU, Japan, Brazil, etc
- Be a technical co-ordinator and co-ordinate with RA CMC team for timely submissions
- Performing final quality review and technical validation before submitting to the Agency/Stakeholders
- Demonstrates deep understanding of ECTD/CTD/Nees type of submissions
- Archiving all necessary submissions/acknowledgements/correspondences into Sharepoint
- To update Sharepoint on a timely basis
- Updating Tracking Tables to avoid any duplications
- Creating guest user accounts for third-party stakeholders
- Providing appropriate Sharepoint access to other stakeholders to avoid breaching of security
- To support other Regulatory operations activities including, but not limited to Sharepoint and other publishing activities
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Sun Pharmaceuticals Walk-In Interview for Production and Engineering Roles[/caption]
Required Qualifications and Experience
To qualify for this position, candidates should meet the following criteria:
- Education:
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field.
- Experience:
3-8 years of experience in regulatory operations or compliance, with expertise in publishing eCTD/CTD/Nees submissions.
- Skills:
- Proficient in Regulatory Compliance and Regulatory Labeling.
- Strong knowledge of global regulatory submission processes.
- Excellent coordination and communication skills, with the ability to manage cross-functional teams.
How to Apply
For more details, apply directly through their
LinkedIn job posting.
https://pharmastuff.org.in/job/sun-pharma-hiring-regulatory-operations-publishing
