Primary Job Function :
With Manager Support :-
- 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
- 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
- Affiliate Coordination
- Maintains strong working relationships with Regional Product Leads and Affiliate colleagues
- 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
- Strategy
- Develops Regulatory CMC strategies for assigned products and projects
- Identifies, communicates, and mitigates Regulatory CMC risks
- Process Improvement
- Identifies opportunities and suggests improvements
- Supports the development of position papers & work aids etc
- Health Agency Interaction
- Attends Health Agency meetings as appropriate
- Licensing Reviews
- Provides CMC Regulatory support for due diligence activities
- 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
