Primary Job Function
With minimal Manager Support:-
1. Product registrations /Submissions
- Leads and coordinates project registrations for complex filings, including new product introductions
- Identifies and collects data needed, or delegates where appropriate
- Seeks and evaluates expert advice and technical support where necessary
- Prepares responses to deficiency letters
2. Relationships & Cross Functional team work
- Represents Regulatory Affairs at relevant meetings and presents agreed RA position
- Provides expert advice and technical support to cross-functional colleagues
- Monitors actual versus planned activities and timelines.
- Proactively 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 ensures files are updated accordingly
- Has expert knowledge of legislation and current developments within specific area of business
- Acts as a subject matter expert within specific area of business
- Manages corrective action plans and drives to completion within agreed timelines
5. Strategy
- Leads and coordinates the development of regulatory product strategies for assigned products and projects
- Identifies, communicates and mitigates regulatory risks
6. Process Improvement
- Independently identifies opportunities and suggests improvements for resolution
- Leads the development of position papers & work aids etc
7.
Health Agency Interaction
- Takes a leading role in preparing for and attending Health Agency meetings as appropriate
- Liaises (including acting as the single point of contact if necessary) with Notified Bodies and other medical device organisations (may not be applicable to all staff)
8. Licensing Reviews
- Leads and coordinates regulatory due diligence activities for assigned projects
9. Technical competency
- Has expert knowledge of global regulatory requirements
- Has specialist regulatory knowledge of assigned country, region, product class requirements
- Has expert knowledge of allocated products
- Takes active steps to keep knowledge current
CORE COMPETENCIES
Anticipation
- Develops scenario and contingency plans that ensure achievement for results under changing conditions and situations
- Takes initiative to implement change to mitigate risks, solve issues or improve processes and ways of working.
- Actively gathers customer inputs in order to anticipate and fulfill their needs and requirements
- Manages internal/external stakeholders to identify and address issues
- Understands the situation or audience and adjusts approach to achieve desired outcomes
Adaptability
- Effectively prioritizes and plans long-term (months/years) work tasks and projects
- Develops “big picture” thinking to Identify synergies and opportunities across the organisation
- Regularly reviews commitments and re-prioritises activities or negotiates timelines as necessary
- Reacts quickly to solve problems and issues as they arise
- Provides guidance and advice to colleagues
Initiative
- Has a clear understanding of the organisation and 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
- Maintains strong customer focus.
Innovation
- Uses intrapreneurial skills to identify and execute new or unique ways to address work problems and opportunities
- Creates an environment of experimentation and uses failure as an opportunity to learn and take alternate action
- Challenges current thinking and generates new ideas. Encourages others to do the same
- Integrates information from multiple sources to generate unique insights or new solutions that increase competitiveness
- Leverages diversity of people and thinking to create a competitive advantage
- Collaborates across boundaries to create cross-business 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 drives completion of individual and shared goals
LEADERSHIP COMPETENCIES
Set Vision and Strategy
- Uses influencing and negotiation skills to drive strategic alignment of key cross-functional stakeholders
- Drives the generation of robust regulatory strategies for complex global projects
Build Organization and Inspire People
- Mentors junior team members
- Provides training and support on areas of subject matter expertise
- Demonstrates leadership skills in day to day work and encourages the same traits in others
- Provides insight, knowledge and leadership to improve functional area and build the business
- Develops and demonstrates strong leadership skills and encourages others to do the same
Drive Results
- Displays energy and persistence to drive the organization forward
- Delivers what is promised; holds self and others accountable for results, commitments and behaviors
- Takes appropriate accountability for failure; does not blame others
- Takes action in a timely manner, with urgency or caution as appropriate, but always in a planful way
- Balances short-term and long-term priorities and maximizes the opportunities for both
- Addresses organizational or cultural barriers that could prevent success
Make Difficult Decisions
- Identifies crisis situations and elevates appropriately
Encourage an Open Environment and Knowledge Sharing
- Provides accurate, frequent and constructive feedback to subordinates, peers and leaders
- Openly shares information with peers
- Challenges and expects to be challenged
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
10+ years’ experience in Regulatory Affairs, R&D, Manufacturing or related area. By exception, less experience is acceptable, e.g. if supplemented by other relevant knowledge such as a higher degree in a related discipline.
