Shire Jobs

Mobile Shire Logo

Job Information

GE Healthcare National Regulatory Affairs Associate in Chalfont St Giles, United Kingdom

Job Description Summary

This role is an entry level role for those who are looking to start a career in Regulatory Affairs. As a National Regulatory Affairs associate you will be supporting UK and Ireland related regulatory activities with varying levels of responsibility, autonomy and roles assigned.

Job Description

This role supports key specific parts of the lifecycle management process of Marketing Authorization maintenance, for example, submissions to MHRA/HPRA, processing of approvals, labelling aspects and obtaining necessary Regulatory fees.

In this role you will be responsible for providing support to regulatory submissions in an efficient and timely manner through cross collaboration with multiple stakeholders and uphold “right first time” submission quality and timeliness.

This role will report to Regulatory Affairs Associate Director NE, UKI.

Key Responsibilities/Essential Functions Include:

  • Ensure (interim) National Regulatory Affairs UKI staff are supported with their submissions by providing the relevant support on document requests with minimal direction.

  • Plan, prepare and implement simple submissions (if possible) for UK and IE, and assist with the preparation and planning of regulatory submissions for UK and IE.

  • Create or update mock-ups of labelling items in the Artwork Management System for local UK or IE submissions.

Qualifications/Requirements:

  • Studying for or having Degree in Life Sciences (anything related)

  • With or without experience in Pharmaceutical Industry (anything related)

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.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Total Rewards

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.

#LI-DG1

#LI-hybrid

Additional Information

Relocation Assistance Provided: No

DirectEmployers