Piramal BSc Chemistry Job. Manager- Regulatory Operations job opening 2023, Chemistry job opening 2023, BSc job opening 2023, Primal job opening 2023, Chemistry job opening 2023. Intrested and eligible candidates may check out all the details on the same below:
Job Title: Manager- Regulatory Operations
Location: Mumbai, Maharashtra, India
Qualifications – External
- B.S. degree or equivalent in a science or related field preferred.
- Experience with document management systems and publishing software (tools) to support paper and electronic submission publishing.
- Working knowledge of eCTD structure and requirements.
- 4-7 years of relevant regulatory publishing experience in the US; publishing experience for the EU and ROW markets is highly preferred. Previous experience with Pharma Ready is preferred.
Soft skills:
- Ready to take challenges in work
- Will need to coordinate intra and inter-department and across sites globally
- Ability to manage multiple projects/activities
JOB DESCRIPTION
- Publish Electronic Submission of the registration dossier, variations, annual reports and responses to questions in eCTD format via the Electronic Submissions Gateway (ESG), Common European Submission Portal (CESP) or equivalent submission portal utilizing in-house publishing software.
- Prepare documents for submission by scanning, rendering, bookmarking, and hyperlinking.
- Perform quality checks for document integrity and compliance with regulatory standards.
- Troubleshoot document issues and provide guidance to company employees on best practices and regulatory requirements.
- Prepare and maintain electronic templates that will be used company-wide for the preparation of submission documents.
- Convert paper submissions to electronic publishing, as required.
- Prepare and submit Structured Product Labeling/Drug Listings to FDA via the Electronic Submissions Gateway (ESG), as required.
Prepare and submit Establishment Registrations to FDA via the Electronic Submissions Gateway (ESG), as required. - Prepare and submit safety reports to FDA and Health Canada via the ESG, as required.
Manages compilation and submission of Periodic Adverse Event Reports for USFDA, as required. - Monitors the relevant current USFDA, EMEA and ICH guidances and requirements for ePublishing. Provides feedback to the business on changes and impact/updates required to ensure Piramal remains compliant and competitive with regard to the relevant systems.
- Manage the publishing team and allocates priorities and resources as appropriate.
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