Regulatory Submission Development Lead, Bangalore, India ExecuPharm, Inc - Bangalore,.."R"

Regulatory Submission Development Lead, Bangalore, India
ExecuPharm, Inc - Bangalore, Karnataka

A Leading Global Top 10 Pharmaceutical company based in Regulatory Submission Development Lead are looking for the best talent to join their expanding team. If you are an experienced Regulatory Consultant and you are looking for your next step in your career then this could be the role for you.

The Role and your Responsibilities

Responsible for planning, coordinating, compiling and reviewing regulatory submissions such as Renewals and Annual NDA and IND Reports for release to Country Operations and/or submission to Health Authorities. Responsible for obtaining, processing and releasing/submitting original regulatory documents for routine submissions Responsible for tracking milestones for assigned work. Responsible for accessing and maintaining various databases to fulfill daily functions and Records Retention tracking and management.

Primary Activities:
1. Prepares alert notifications
2. Drafts cover pages and appropriate sections
3. Drafts administrative forms, reviews all components against plan, assembles components from all contributing departments into the format and content required by current regulations Initiates, tracks and expedites the review and approval to assure compliance, timeliness and frequency of reports with current country regulations and by the established target dates Initiates corrective action when discrepancies are noted, and facilitates a satisfactory resolution of related problems/issues
4. Responsible for accessing and maintaining various databases in fulfillment of daily functions

What is Required

• 5 years experience in the pharmaceutical regulatory affairs area.
• Excellent written and oral communication/interpersonal skills.
• Able to multitask with proven project management capabilities including managing dynamic timelines, interacting and negotiating with others, collaboration skill and excellent follow-up ability.