Job Description

JOB DESCRIPTION:

1. Product registrations / Submissions

-Assists in product registrations by preparing/ requesting documentation needed for complex filings

-Employs project management skills to monitor activities and meet deadlines

-Prepares registration packages for routine filings

-Identifies and collects data needed

-Seeks expert advice and technical support for complex filings

-Prepares responses to deficiency letters

2. Relationships & Cross Functional team work

-May represent Regulatory CMC at relevant project meetings and communicates agreed RA position

-Monitors and communicates actual versus planned regulatory activities and timelines

-Identifies and communicates risks and issues impacting project progression

3. Affiliate Coordination

-Builds and maintains strong working relationships with Regional Product Leads and Affiliate colleagues

4. Compliance across Life-Cycle

-Assesses and approves change requests and updates files accordingly

-Maintains awareness of legislation and current developments within specific area of business

-Works to assure products remain in compliance

5. Strategy

-Participates in the development of Regulatory CMC strategies for assigned products and projects

-Takes steps to identify, communicate, and mitigate Regulatory CMC risks

6. Process Improvement

-Identifies opportunities and suggests improvements

-Provides input into the development of position papers & work aids etc

7. Health Agency Interaction

-Helps to prepare for Health Agency meetings as appropriate

8. Licensing Reviews

-Can provide CMC Regulatory support for due diligence activities

9. Technical competency

-Has general knowledge of technical/scientific principles and some specific knowledge of allocated products

-Has general knowledge of global and regional regulatory requirements

-Starts to develop specialist regulatory knowledge of assigned country or product-class requirement

The salary for this role is between: N/A

JOB FAMILY: Regulatory Operations

DIVISION:

LOCATION: India
Mumbai : Mumbai Development Center - EPD

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: Yes, 50 % of the Time

MEDICAL SURVEILLANCE: Not Applicable

SIGNIFICANT WORK ACTIVITIES: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)