Regulatory Project Head

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/ManagementResponsibilities:

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.