Senior Executive - Regulatory Affairs - Pharma (4-6 yrs)
Designation : Sr. Executive - RA
Reporting to : Deputy Manager RA / Head - RA
Qualification : M. Pharma / M.Sc
Experience : 4 - 5 years of experience in RA
Location : Chennai, Gumudipundi & HO Chennai
Candidate should have expertise knowledge in USFDA regulations and compliances. Should have good command over English and documents filling, Should be a very good team player. Should have open mind to interact with the entire cross functional teams.
1. Preparation of CTD/eCTD dossiers for various regulatory agencies.
2. Preparation & Review of SOPs related to Regulatory submissions.
3. Co-ordination with various departments like production, QA, QC, R&D for Regulatory documents. And preparation of documents for NOC, Test license, Import license and Manufacturing licenses
4. Review & Approval of specifications, STP to make in-line with USP, Ph.Eur.
5. Review & Approval of protocol and report as per Regulatory aspects (eg. Stability, Analytical method validation and etc.)
6. Preparation of database for various regulatory guidelines.
7. Maintaining matrix for different products as per the requirements of different Regulatory agencies
8. Providing training on Regulatory requirements.
9. Responsible for submission activities (planning, authoring, reviewing, e-submission) for all markets
10. Preparation and review of Sterilization Assurance Package for Sterile Injectable and Ophthalmic products as per regulatory requirement.
11. Responsible for submission of queries/deficiencies, post approval submissions and Annual Reports
12. Regulatory assessment and ensure requirements to avoid the RTRs
13. For product submissions, conduct project start-up/kick off meetings and document review meetings with the project team to confirm submission strategy and approach
14. To Identify the content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines
15. Responsible for Effective implementation of eCTD software (PharmaReady), SPLs including ESG Gateway submissions.
16. eview of all technical documents related to product submission as per Regulatory guidances (Eg. Stability, Analytical method validation etc.)
17. To comply with FDAs GDUFA requirements for the facility and ANDA submission.
18. Preparation of database for various regulatory guidelines.
19. Maintaining matrix for different products as per the requirements of different Regulatory agencies
20. Assessment of scope extension process for various markets
21. Identifying regulatory risks and mitigations in change controls
22. Providing regulatory guidance/opinion in case of changes/deviations/new proposals
- Candidates having injectable / Formulation background are highly preferred.
- Candidates must be self motivated with excellent written and verbal communication skills. Good interpersonal and project management skills are critical for this position.
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