Job Description Summary

As the Regulatory Affairs Manager of UK and Ireland (Pharmaceutical Diagnostic Products), you will be responsible for the registration of new medicinal products and/or maintenance of marketed medicinal products, and for providing regulatory guidance in assigned area.

Responsibilities
 

• Main regulatory point of contact with national regulatory authorities (i.e. MHRA and HPRA) on behalf of GEHC Pharmaceutical Diagnostics:
• All submissions for marketed medicinal 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 Regulatory contact for promotional material of medicinal products in local market incl. preparing prescribing information
• Provide regulatory support to local commercial and global business priorities
• Provide input to RA budget for local market activities
• 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.)
   

Qualifications and experience
 

• Bachelor’s Degree (or equivalent) and significant progressive regulatory affairs management experience in medicinal products, including extensive experience negotiating directly with regulatory agencies
• Proven track record in dealing with the MHRA and HPRA
• 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 pharmaceutical products Regulatory Affairs
• Demonstrated knowledge & experience conducting scientific, regulatory, legal, or business research
• Prior experience using spreadsheet and presentation software
• Must be willing to travel up to 5 % of time
   

Desirable skills
 

• 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 with regards to medicinal products
  
   

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