Regulatory Project Head

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 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.

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES: