**JOB DESCRIPTION:Primary Job Function: *With Manager Support:

• *1. Product registrations / Submissions
  -Actively leads 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:

-Represents 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

-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

-Develops Regulatory CMC strategies for assigned products and projects
-Identifies, communicates, and mitigates Regulatory CMC risks

6. Process Improvement

-Identifies opportunities and suggests improvements
-Supports the development of position papers & work aids etc

7.

Health Agency Interaction:

-Attends Health Agency meetings as appropriate

8. Licensing Reviews

-Provides CMC Regulatory support for due diligence activities

9. Technical competency
-Has general knowledge of technical/scientific principles and develops specific knowledge of allocated products
-Has general knowledge of global and regional regulatory requirements
-Has specialist regulatory knowledge of assigned country or product-class requirements

**CORE COMPETENCIESAdaptability
-Effectively prioritizes mid-term (weeks) to longer-term (months) work tasks
-Regularly reviews commitments and re-prioritises activities or negotiates timelines as necessary
-Reacts quickly to solve problems and issues when they arise

Initiative

-Starts to learn new aspects of the business and understand the roles of other functions
-Proactively anticipates, mitigates and avoids problems and issues
-Proactively seeks feedback from manager and team members and adapts behaviour to improve performance

Innovation

-Has an intrapreneurial mindset to identify new or unique ways to address work problems or opportunities

Integrity

-Delivers high quality results.
-Meets agreed deadlines.
-Exhibits honesty and presents complete impartial information.
-Displays consistency between words and actions.
-Acknowledges and responds constructively to failures and mistakes.
-Expresses dissatisfaction constructively, without over-reacting.

Teamwork
-Actively interacts with colleagues to drive completion of team and shared goals

**LEADERSHIP COMPETENCIESSet Vision and Strategy
-Clearly articulates Regulatory CMC strategies and obtains alignment and agreement from key stakeholders

Build Organization and Inspire People

-Mentors junior team members
-Provides training and support on areas of subject matter expertise
-Proactively strengthens own leadership skills and actively uses these skills in day to day work

Drive Results

-Encourages others to complete goals

Make Difficult Decisions

-Interacts with cross-functional and department colleagues to help drive efficient decision-making

Encourage an Open Environment and Knowledge Sharing
-Provides honest, accurate feedback to managers, whether positive or negative
-Not afraid to challenge peers and managers and be challenged
-Openly shares information with peers

Supervisory/Management Responsibilities:

Direct Reports:     None (individual contributor)
Indirect Reports:    None (individual contributor)

Minimum Education: Bachelor's Degree in pharmacy, biology, chemistry, pharmacology, or related subject

Minimum Experience/Training Required: A minimum of 10 years of experience in Regulatory Affairs, R&D, Manufacturing or related areas

The base pay for this position is
N/AIn specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Regulatory Operations

DIVISION:

EPD Established Pharma:

LOCATION:

• India > Mumbai : Mumbai Development Center
• EPD

ADDITIONAL LOCATIONS: ##WORK SHIFT:
Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:
Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)