Senior Executive/Team Leader - Regulatory Affairs (US Market)

1. To ensure quality ANDA and supplement filings within the stipulated timelines.

2. Responsible for deficiency management and filing of deficiency response within the deadline.

3. Represent RA in new product review meeting (Review-0, Kick off meetings) and for approved product

introduction to other manufacturing sites, new strength, new source, new SKU, SUPAC changes and

CMC changes meetings.

4. Regulatory gap assessment & making Control Correspondance to derisk the Regulatory submissions and

to facilitate approval in time.

5. Reviewing compiled ANDA, supplements, post approval market status communications and deficiencies

responses per USFDA regulatory requirements for US market.

6. Involving in ANDA, life cycle management activities, quality events discussions, change management

(Track wise & Salesforce) & related documents review, preparation, and finalization in eCTD format

using eCTD dossier management software.

7. Co-ordinate with various cross functional team members for collecting the documents required for

compilation of ANDA and responding to US FDA deficiencies and other applicable submissions as the

case may be.

8. Co-ordinating with CFT to facilitate batch executions to meet Organization goal.

9. Vendor change management, Pharmacopoeial change management, CMC changes including complete

life cycle management, evaluating the changes proposed in the Trackwise / Salesforce tools, and

compilation/review of supplements for the proposed changes.

10. To assist regulatory supervisor/ head in formulizing various regulatory documents as required for

formalizing regulatory strategy for various submissions.

11. Reviewing Product Development Plans, Reports and other required documents as a part of regulatory filing for US market.