Regulatory Affairs Senior Specialist – International Labeling Support (ILS)

Job Description

We are looking for one motivated and talented individual to join our company as a Regulatory Affairs Senior Specialist in Prague.

The role reports to the International Labeling Support (ILS) Associate Director and will partner cross-functionally within GRACS and across divisions to support the end-to-end labeling process, including development, maintenance, and artwork implementation. The role also contributes to continuous process improvement, compliance oversight, and training initiatives, while serving as a subject matter expert in labeling-related investigations and audits.

Specific responsibilities include:

• Prepares high quality labelling, artwork package aligned with company requirements and provides operational support to Country Regulatory Affairs on regulatory activities (database maintenance, records filings) according to the ILS scope of work

• Prepares and reports metrics related to the designated business process

• Collaborates with Global Labeling, Country/Regional Regulatory Affairs, and Manufacturing Division for labeling & artworks queries

• Facilitates updates to process documentation and contributes to re-engineering/simplification efforts

• Delivers training and support knowledge-sharing initiatives on labeling procedures

• Leads or contribute to continuous improvement, re-engineering, and simplification of labelling and artwork processes and related tools

• Provides SME support for Level 2 labeling-related issues and significant investigations

• Assists in audit and inspection readiness related to ILS scope of work

• Partners with Country Regulatory Affairs to collect necessary inputs and country requirements for the accurate planning and execution of the business process

• Participates in cross functional/divisional projects for coordination, planning and implementation of changes with impact on Labeling/artworks: CMC changes with artwork impact, artwork preparation for launches, liaising with country regulatory affairs where necessary

Requirements:

• Bachelor’s degree in life science, engineering, business or a related field (ideally pharmaceutical science degree), Master’s degree is desired

• Minimum 3–5 years’ experience in pharmaceutical industry

• Previous experience in Regulatory Affairs (including artwork & labeling), CMC, compliance management or Quality, working with external partners and/or dealing directly with regulatory agencies is preferred

• Desirable to be familiar with local and regional legislation frameworks, procedures and guidelines governing pharmaceutical products

• Preferably some knowledge of our company's business and organizational set-up

• Understanding of Operational Excellence principles

• Ability to work through a matrix approach in a culturally diverse environment across the regions

• Good organizational skills with a proven ability to simultaneously balance diverse activities for several projects

• Good interpersonal/communication skill

• Detail and quality oriented

• Able to master Microsoft 365 apps (Excel, Power point, SharePoint)

• Technology proficiency; Interest in new tools or automatization will be needed

• Innovative mindset and design thinking skills

What we offer: 

• Exciting work in a great team, global projects, international environment

• Opportunity to learn and grow professionally within the company globally

• Hybrid working model, flexible role pattern

• Pension and health insurance contributions

• Internal reward system plus referral program

• 5 weeks annual leave, 5 sick days, 15 days of certified sick leave paid above statutory requirements annually, 40 paid hours annually for volunteering activities, 12 weeks of parental contribution

• Cafeteria for tax free benefits according to your choice (meal vouchers, Lítačka, sport, culture, health, travel, etc.), Multisport Card

• Vodafone, Raiffeisen Bank, Foodora, and other discount programs

• Up-to-date laptop and iPhone

• Parking in the garage for drivers or showers for bikers

• Competitive salary, incentive pay, and many more

Ready to take up the challenge? Apply now!
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