Senior Manager - Regulatory Affairs

Primary Job Function:

-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

-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.

- Maintains strong working relationships with Regional Product leads and Affiliate colleagues

-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

-Leads and coordinates the development of regulatory product strategies for assigned products and projects

-Identifies, communicates and mitigates regulatory risks

-Independently identifies opportunities and suggests improvements for resolution

-Leads the development of position papers & work aids etc

7.

-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

-Leads and coordinates regulatory due diligence activities for assigned projects

-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

-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

-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

-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.

-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

-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

-Actively drives completion of individual and shared goals

LEADERSHIP COMPETENCIES

-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

-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

-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

-Identifies crisis situations and elevates appropriately

-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.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

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MEDICAL SURVEILLANCE:

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