Head - Regulatory Affairs - US Markets - Pharma

Graduate or Post Graduate in Science with at least 12+ years of relevant experience.

At least 12+ years of experience. Exposure to working in US Markets is Mandatory. Should have filed at least 20 ANDA's.

Key Roles/Responsibilities:

Development Stage:

- To lead regulatory strategy for ANDA and IND filing pipeline of the company, including providing assessments, opinion, analysis and pathways.

- To work closely with development and project management team to identify bioequivalence pathways for challenging high barrier topical products.

- To lead discussions on creating alternate regulatory pathways for bioequivalence by negotiations with the US FDA.

- To lead Pre-IND and IND discussions with FDA.

- To help trouble-shooting development activities wherever there are obstacles.

- To prepare and review CMC, Labeling and Bio equivalence studies, amendments & Global Supplements.

- Review of various documents like Packaging equivalency protocol, Method Validation Reports, Batch records, validation reports, etc.

- To review ANDA and file electronically through FDA gateway.

- Pre-approval Submission in original ANDA filing, getting the AFFL letter with no RTR and DL responses in time.

Post filing & approval stage:

- Post-approval submission expertise in PAS, CBE-30, CBE-0 submissions including manufacturing site transfers, alternate API projects etc.

- FDA Correspondences on day to day basis regarding the review status and pushing them for fast approval of the applications. (FDA Telephone contact report)

- Responsible for developing and maintaining the processes, deliverables, execution and group skills to ensure quality and compliance for all activities related to the assigned roles in submissions management.

- Maintains competent knowledge for current/emerging regulations, guidance documents and corporate/industry standards for their impact on strategic plans and tactical operations.

- Engages in problem solving and decision making in conflict management and process management.

- Preparation and review of end user letter.

- Reports, Stability protocols and data, COAs, Process validation protocols etc.

- Review of various Documents like Method Validation Reports, BPRs, A.R. Reports, Stability protocols and data, COAs, Process validation protocols etc.

- Monitor change control proposal to eliminate non-compliance risks.

- Attending the product development meetings to ensure that the product complies with all regulatory requirements and to understand the product history.

- To obtain Manufacturing/ Test licenses.

- Preparation, review & submission of ANDA's / Dossiers to Regulatory Authorities.

- Review and finalization of development reports, specification for drug substance, drug product & excipients.

- Compilation and filing of controlled correspondences & bio correspondences with US FDA.

- To prepare and review Annual Reports.

For more info please call Ajay Kasar +91 9820895929 (Mon to Sun from 10.00AM to 9.30PM)