Regulatory Affairs Manager

Manager - Regulatory Affairs

     

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 COMPETENCIES

Adaptability
-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 COMPETENCIES

Set 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/A

In 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)

     

     

     

Experience Level

Senior Level