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General Electric Quality Lead Specialist 1 - Regulatory Affairs in Amersham, United Kingdom

Job Description Summary

As the Regulatory Affairs Manager of UK and Ireland, you will be responsible for registrations of new products and/or maintenance of marketed products, and for providing regulatory guidance in assigned area.

Job Description

Responsibilities

  • Main regulatory point of contact with national regulatory authorities on behalf of GEHC:

  • All submissions for marketed products to be made as per agreed priorities/timelines to assure

  • and maintain regulatory compliance

  • Maintain strong regulatory authority interactions to ensure appropriate input to regulatory

  • strategy and gain rapid approval of submissions

  • Prepare and update Product Information (SmPCs) and artwork (labels and leaflets) for the local

  • market

  • Act as responsible for promotional material in local market incl. preparing prescribing information

  • Ensure local regulatory compliance for all medicinal products

  • Provide regulatory support to local commercial and global business priorities

  • Provide input to RA budget for local market

  • Develop effective national regulatory strategies which meet business goals

  • Proactively provide national regulatory advice and expertise to other groups in RA and in local commercial organization

  • Assist the Regional Head of Regulatory Affairs on any matters related to the affairs of the department

  • Actively seek to represent GEHC´s regulatory function outside the company (local congresses and trade association meetings etc.)

  • To act as liaison with external customers in the process for them to get regulatory approval for the

  • production of PET tracers based on GEHC cassettes

Qualifications and experience

  • Bachelor’s Degree (or equivalent) and significant progressive regulatory affairs management experience, including extensive experience negotiating directly with regulatory agencies

  • Ability to work with minimal supervision on projects and activities

  • Ability to prioritise, plan and evaluate deliverables to established strategic goals

  • Demonstrated experience operating in a highly regulated environment; Proven application of analytical skills in a regulatory environment

  • Demonstrated knowledge & experience conducting scientific, regulatory, legal, or business research

  • Prior experience using spreadsheet and presentation software

  • Must be willing to travel up to 15 % of time

Desirable skills

  • Advanced degree in scientific disciplines (or equivalent) Regulatory Affairs Certification (RAPS).

  • Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment

  • Strong problem solving, negotiation and influencing skills

  • Ability to work well independently and in a team setting to provide timely, constructive and authoritative regulatory opinion and advice on all regulatory aspects

  • Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GEHC regulatory strategies.

Eligibility requirements

A good level of English and a valid work permit

Inclusion and Diversity

GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support

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Additional Information

Relocation Assistance Provided: No

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