As our Regulatory Expert, you will ensure appropriate product approvals and maintenance for company product portfolio including labelling updates.

Further responsibilities:

• Implement suitable regulatory policies and procedures to assist in achieving registration/commercialization of new company products (including licensed products) within the Czech Republic.

• Cooperation with Global Regulatory Teams.

• Coordinate translation of regulatory related labelling (SmPC, PIL, packaging) with keeping tough deadline for procedures (CP, MRP, DCP, NP).

• Coordinate artwork creation process within portfolio responsibility, cooperation with Artwork coordinators  and Manufacturing sites

• Close cooperation with Medical department, QA, PV and Supply

• Cooperation with Therapeutical Area managers and Corporate Affairs

• Responsibility for EU and local legislation monitoring.

• Cooperation with Health Authorities (SÚKL, MoH)

Basic Qualifications & Skills:

• Technical, scientific and/or medical university degree

• Experience in Regulatory Affairs

• Excellent written and verbal communication skills in Czech

• Very good written and verbal communication skills in English

Preferred Qualifications & Skills:

• The ability to independently organize work and prioritize.

• The joy of teamwork and learning new things

• Broader experience working with MS Office applications.

• Experience working in RA Databases and EU legislation knowledge

What we offer?

• Permanent contract in a real inclusive environment

• Smart Working up to 50%

• Performance Reward

• 5 days of paid leave in addition to the Labour Code annual leave allowance

• Paid parental leave and caregiver's leave

• On site Cafeteria

• Flexible benefit

• Partnership for Prevention preventive care programme and Employee Assistance Programme

• Childbirth bonus & 1 paid day off

• Multisport card

• Ergonomic equipment for home office set up

GSK Czech Republic is the most attractive employer in the pharmaceuticals and health care category

(Randstad Award 2024)

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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