Job Description

JOB DESCRIPTION

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 letters2. 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 sharing4. 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 timelines5. Strategy-Leads and coordinates the development of regulatory product strategies for assigned products and projects-Identifies, communicates and mitigates regulatory risks6. Process Improvement-Identifies opportunities and proactively takes steps to implement improvements-Leads the development of position papers & work aids etc7. 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 projects9. 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 currentCORE COMPETENCIESAnticipation-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 outcomesAdaptability-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 colleaguesInitiative-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 opportunitiesIntegrity-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-reactingTeamwork-Uses leadership skills drives completion of individual and shared goals and to develop the skills of othersLEADERSHIP COMPETENCIESSet 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 projectsBuild 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 businessDrive 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 successMake Difficult Decisions-Identifies crisis situations and elevates appropriatelyEncourage 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 challengedSupervisory/Management Responsibilities: Direct Reports: None (individual contributor)Indirect Reports: None (individual contributor)Minimum Education: Bachelor's Degree in pharmacy, biology, chemistry, pharmacology, or related subjectMinimum 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.