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
ntegrates 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:

Bachelors Degree in pharmacy, biology, chemistry, pharmacology, or related subject

Minimum Experience/Training Required:

10+ years experience in Regulatory Affairs, RD, 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.

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