Assistant Manager / Manager Regulatory Affairs
Internship Navi Mumbai, India Project / Product management
Job description
JOB DESCRIPTION:
Primary Job Function:
With Manager Support:-
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 requirements
CORE COMPETENCIES
Adaptability
-Effectively prioritizes short-term (days) to mid-term (weeks) work tasks
-Works with manager to regularly review work commitments and activities
-Reacts quickly to solve problems and issues when they arise
Initiative
-Takes steps to anticipate, mitigate and avoid problems and issues
-Seeks feedback from manager and team members and adapts behaviour to improve performance
Innovation
-Develops 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
-Takes a major role in generating robust Regulatory CMC strategies supporting right-first-time submissions
Build Organization and Inspire People
-Mentors junior team members
-Starts to develop own leadership skills and practices these skills in day to day work
Drive Results
-Complete goals according to agreed deadlines
Make Difficult Decisions
-Provides input into decision-making within scope of project/product responsibilities
Encourage an Open Environment and Knowledge Sharing
-Provides honest, accurate feedback to colleagues, whether positive or negative
-Not afraid to challenge peers 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 8 years of experience in Regulatory Affairs, R&D, Manufacturing or related areas
JOB FAMILY:
Regulatory Operations
DIVISION:
EPD Established Pharma
LOCATION:
India > Mumbai : BKC Building
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 10 % of the Time
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)