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 biosimilar/ biologics 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 requirementsCORE 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
A minimum of 10 years of experience in Biosimilar Global Regulatory Affairs. Proven exposure to US and EU regulatory environment. Experience in emerging markets/ rest of world will be considered an added advantage.
The base pay for this position is
N/AIn specific locations, the pay range may vary from the range posted.