Regulatory Affairs Role - Pharma

1. Serve as the team lead for assigned products and be accountable for the completion of all regulatory milestones for assigned products through the product lifecycle.

2. Execute regulatory strategies by leading the development, authoring and review of submission components for new ANDAs and documentation to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established systems.

3. Review/assessment of documents for regulatory compliance like Drug master files, Specifications, standard test procedures and validation documents of Injectable/Ophthalmic dosage forms.

4. Co-ordination with various sites/teams (viz. development site, manufacturing site, contract testing sites and DMF holder) for collection and review of documents related to ANDA, deficiencies and post approval supplements.

5. Review and approval of Master formula cards, Pharmaceutical Development Report, stability and process validation protocols.

6. Review of development dossier to identify the design flaws at the development stage and support to Head regulatory in finalizing the filing strategies

7. Reviewing BMRs, PBRs and validation reports for appropriateness.

8. Preparation, review and compilation of Original ANDA submissions for US market in eCTD format for Injectable/Ophthalmic dosegeforms

9. Preparation and preliminary review of sterile assurance package (aseptic and terminal sterilization products).

10. Preparation and review of response to Agency's queries and submission within the stipulated time given by USFDA.

11. Preliminary review of draft labels, final labeling artwork, SPL and package inserts.

12. Review and approval of change control documents and ascertain regulatory impact for external and internal documents through formal regulatory assessments.

13. Review and compilation of Annual reports, CBE and Prior approval supplements.