Primary Job Function:
Independently:
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, communicates and mitigates risks and issues impacting project progression.
3. Affiliate Coordination
-Maintains strong working relationships with Regional Product leads and Affiliate colleagues
-Finds ways to improve ways of working and knowledge sharing
4. Compliance across Life-Cycle
-Assesses and approves change requests and ensures files are updated accordingly
-Has expert knowledge of legislation and current developments across different areas of business
-Acts as a subject matter expert
-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
-Identifies opportunities and proactively takes steps to implement improvements
-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 across multiple countries, region, product class requirements
-Has expert knowledge across product protfolios
-Ensures knowledge remains current
CORE COMPETENCIES
Anticipation
-Develops scenario and contingency plans that ensure achievement for results under changing conditions and situations
-Proactively implements 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, including the work of others
-Has “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, advice and mentoring to colleagues
Initiative
-Understands 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
-Uses leadership skills drives completion of individual and shared goals and to develop the skills of others
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 strong leadership skills every day and encourages the same others to do the same
-Provides insight, knowledge and leadership to improve functional area and build the business
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 and managers
-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.
The base pay for this position is
In specific locations, the pay range may vary from the range posted.