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 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:

• Bachelors degree in life science engineering business or a related field (ideally pharmaceutical science degree) Masters degree is desired

• Minimum 35 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 companys 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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Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

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