Senior Manager - Regulatory Affairs - Pharma

Position: Sr. Manager

Minimum Qualification: B. Pharm/ M. Pharm

Experience: 12+ years of experience in Solid Oral Dosage Form ANDA Submission and Life Cycle Management

Job Description:

- Regulatory support and review for pre-filing and development documentation.

- Coordination with internal and external stakeholders for regulatory filing related documentation.

- Review, compilation and authoring of CMC, bio pharmaceutics, labeling, module 1 document

- Review of plant and R&D documentation such as development reports, BMR, BPR, Specifications, method validation, process validation etc.

- Authoring, Compilation and review of ANDA dossier in eCTD format, followed by publishing, validation and submission of dossier

- Authoring, Compilation and review of Structure Product Labeling (SPL)

- Consulting, categorizing, authoring Post approval changes through appropriate supplements. Submission of annual reports on respective anniversary dates

- Participation in regulatory audits from US FDA and provide regulatory support.