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General Electric Regulatory Affairs Specialist (f/m/d) – Germany & Switzerland in Munich, Germany

Job Description Summary

In this key regulatory role for our Pharmaceutical Diagnostics Business you will deliver an effective regulatory capability for Germany and Switzerland.

Job Description

GE Healthcare (https://www.gehealthcare.de/) is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Please find out more about our Pharmaceutical Diagnostics Products here (https://www.gehealthcare.de/products/nuclear-imaging-agents) !

This position will cover Regulatory Affairs (RA) activities for pharmaceutical products for Switzerland and Germany!

This role can be based either in Munich with a lot of workplace flexibility! The position is remunerated in accordance to the collective agreement Chemistry (Tarif Chemie Bayern, EG 10-12).

Germany :

You will support all maintenance and life-cycle activities for pharmaceutical products within national and international practices (MRP, DCP, CP):

  • Preparation, update, review of regulatory texts (SmPC, PIL, Labelling)

  • Preparation, update, review of artwork

  • Review of advertising material

  • Communication and coordination with stakeholders to ensure the necessary measures for maintaining regulatory compliance of the existing drug approvals (Life Cycle Management)

  • Support in update/preparation of SOPs

  • Maintain data in information systems or databases

  • Identify and interpret relevant regulatory guidelines and ensure compliance

  • Advise others on regulatory matters; Explain regulations, policies, or procedures

  • Evaluate applicable laws and regulations to determine impact on company activities

  • Responsibility for local regulatory archive

Switzerland:

You will provide Pre- and post-market support:

  • Conduct research on new submission requirements and options, monitor and communicate about upcoming challenges in the Swiss market

  • Assist in regulatory projects, track processes incl. timely entries in regulatory databases and systems as well as compliant document archiving

  • Support in compiling SL-applications to the BAG

  • Prepare, update, and review Swiss product labelling (SmPC, basic text, labels) to ensure conformity with current applicable regulatory requirements

  • Perform a variety of tasks in support of preparation of submission packages for Swissmedic within life-cycle management (variations, extension, PSURs, safety signals, and MA applications) in cooperation with other stakeholders

  • In dependence on existing language skills: Support of the person responsible for advertising material as required

Your Profile

Regulatory Affairs Experience:

  • University degree in life sciences (pharmacy, chemistry, biology or related discipline)

  • Proven professional experience in the field regulatory affairs with pharmaceutical products

  • RA experience in Germany as well as in Switzerland

  • Experience in national and international practices (MRP, DCP, centralized procedures)

  • Profound knowledge of the requirements for marketing authorization applications as well as the appliance and interpretation of relevant guidelines

  • Profound knowledge as well as the appliance and interpretation of applicable laws/guidelines/requirements for MAA and life cycle management of pharmaceutical products

  • Ability to work in an interdisciplinary manner with decision-making, certain flexibility and an understanding of marketing necessities

  • Experience of review of Marketing Material in Germany (HWG, UWG, FSA); experience as Information Officer acc. § 74a AMG is an asset

  • Knowledge & experience conducting scientific, regulatory, legal, or business research

  • Experience in Health Authority negotiations

  • Fluency in German and English

  • Strong sense of responsibility and attention to detail

  • Well- organized and result-oriented approach, including a problem-solving attitude

  • Strong planning skills, ability to prioritize

  • Very good communication and social skills

  • Ability to work across cultures and in teams with different sizes

Desired skills/experienced that can be further developed "on-the-job" are:

  • French and/or Italian language skills

  • Experience working with Veeva, Document Management Systems

Ability to work in a team and working independently

  • Decision-making competence, sense of responsibility, reliability and flexibility

  • Ability to work across cultures

  • Ability to manage regulatory processes to ensure approvals and maintenance of products

Are you interested in learning more? Then please apply online. For any question upfront please reach out to our recruiter Carolin Krone on carolin.krone@ge.com . Please note that for Data Privacy compliance we are not able to accept any e-mail applications!

About us

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.

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.

GE Healthcare – every moment matters

#LI-KRONE

Additional Information

Relocation Assistance Provided: No

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