Job Description

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.