13 days old

Head of Regulatory Affairs, US & Canada

GE Energy
Marlborough, MA 01752
Role Summary:This position will lead the Regulatory Affairs function for the US/Canada region and will have responsibility: to ensure that team resources are appropriately deployed and US-FDA and Health Canada regulatory strategies are optimized and aligned with business needs; to maintain strong and effective relationships across Global RA and with key stakeholders across GE; and ensure US-FDA and Health Canada requirements are factored into global development plans and life cycle management strategies.

Essential Responsibilities: Leads the US/Canada Regulatory Team, ensuring high quality strategic advice and be seen as a valued strategic partner for wider GE

Ensures that highly effective proactive strategic input is provided to Global Regulatory plans

Ensures delivery of major new product filings, lifecycle registration and compliance commitments are met

Builds effective working relationships with FDA and Health Canada

Is the Subject Matter Expert for FDA requirements, ensuring effective strategy development and deployment

Develops clear priorities for the team and communicates those to the business so that expectations are appropriately managed

Monitors the external environment, with a view to influencing changes to the benefit of the business and adapting regulatory strategies proactively

Participates as a full and active member of the Regulatory Affairs Leadership Team, other key function working parties and key decision making bodies within GEHC e.g. portfolio Committee and Phase Review Discipline and acts as delegate for Global Head of RA as appropriate

Implements and manages effective resource allocation processes within the team and deploys external support to meet business demands

Proactively identifies third parties to supplement team expertise and additional capacity requirements and effectively manages contract/temp resources and contracting processes Supports and encourages a collaborative, open and team based culture across the global function

Engenders close and effective working with regional Global Regulatory Strategy, National Regulatory Affairs for other regions and RISM colleagues and actively resolves areas of conflicts or sub optimal operation

Ensures effective strategies are in place for attraction, retention and succession planning for the team

Ensures that function systems and supporting processes are adequate for effective team operation and that an ongoing process improvement mindset is instilled within the team

Qualifications/Requirements: Bachelor's Degree or a minimum of 15 years work experience

Minimum 12 years experience in Regulatory Affairs within the pharmaceutical industry preferably in a regional role or as Head of US or Canada national regulatory affairs

Experience of global regulatory affairs from the pharmaceutical and/or healthcare industry

Significant experience of effective interaction with FDA and its relevant divisions

Demonstrated experience interfacing with US FDA is required (and with Health Canada a plus), including negotiation of pharmaceutical product approvals and lifecycle maintenance, resolution of issues and influencing/lobbying directly and through other external groups (e.g. trade associations)

Demonstrated ability to form, lead and manage cross-functional, cross-business teams; significant experience leading regulatory strategy and regulatory teams

Prior experience with regulatory project management and management of regulatory projects in global regulatory organizations

Experience working globally and across different cultures

Desired Characteristics: Masters degree in a scientific discipline

Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on regulatory strategies in US and Canada would be highly desirable

Third party management and vendor selection experience (desirable)

Ability to lead and inspire

Persuasive, Influential and fosters an environment of teamwork

Strong verbal and written communication skills

Decisive and tenacious

Ability to manage multiple competing tasks, meet deadlines and assign clear priorities

About Us:With 4000+ employees serving 100+ countries, GE Healthcares Pharmaceutical Diagnostics (PDx) business is the number one global supplier of contrast media and molecular imaging agents used in medical imaging exams to improve the visibility of organs, blood vessels or tissues, often helping radiologists distinguish between normal and abnormal conditions. PDx products makes a huge impact worldwide - supporting three patients every second.

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.

Additional Eligibility Qualifications:GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).Additional Locations:United States;Massachusetts;Marlborough, MA; Arlington Heights, IL; or field based;


Posted: 2020-06-19 Expires: 2020-07-19

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Head of Regulatory Affairs, US & Canada

GE Energy
Marlborough, MA 01752

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