IDMP Senior Specialist

2 days ago

Prague, Hlavní město Praha, Czech Republic MSD Full time €80,000 - €120,000 per year

Job Description

Do you have a passion for driving business excellence in the pharmaceutical industry? We're seeking a talented IDMP (Identification of Medicinal Products) Business Analyst to play a key role in ensuring compliance with Article 57 of EU Regulation 1235/2010 (XEVMPD/IDMP) within Regulatory Affairs Operations (RRO) – EMEA.

Key Responsibilities:

  • Coordinate activities to ensure IDMP readiness and compliance with European regulatory requirements
  • Contribute to the definition of future state IDMP processes and enhance XEVMPD solutions within the company
  • Collaborate on global initiatives to expand internal source systems and improve interoperability using ISO IDMP as a common language
  • Participation to the global initiative to expand internal source systems, to become compliant with IDMP in the EU, as well as PQ/CMC in the US. Another objective is to expand the interoperability across these systems, using ISO IDMP as a common language
  • Participation to the setup of a central group to manage IDMP-related data to support Regulatory Affairs activities in scope of the Application Form/PLM, IDMP/SPOR, and other EMA systems

Qualifications and Requirements:

  • Strong understanding of regulatory affairs in the pharmaceutical industry, specifically in relation to IDMP and XEVMPD requirements
  • Master data management experience
  • Understanding of governance and project management
  • Veeva or similar complex RIM Implementation
  • Experience in coordinating cross-functional projects and initiatives
  • Excellent communication and interpersonal skills

This is an exciting opportunity to drive impactful change and advance regulatory compliance in a dynamic and collaborative environment

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
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. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Adaptability, Audits Compliance, Communication, Detail-Oriented, Drug Regulatory Affairs, Employee Training Programs, Global Communications, Management Process, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Process Improvements, Project Management, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Operations, Regulatory Strategy Development, Regulatory Submissions

 Preferred Skills:

Job Posting End Date:

09/8/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R361642

  • Senior Specialist, Regulatory

    2 days ago

    Prague, Hlavní město Praha, Czech Republic Ergomed Full time €60,000 - €80,000 per year

    The Senior Specialist, Regulatory and PV Network is responsible for developing the strategy based on regulatory requirements and for driving regulatory and PV deliverables based on an established PV and regulatory plan. They also serve as a liaison between regulatory and other functional areas including external partners, clients, authorities and/or...

  • Senior Technical Support Specialist

    2 days ago

    Prague, Hlavní město Praha, Czech Republic TransPerfect Gaming Full time €40,000 - €60,000 per year

    We're hiring a Senior Technical Support Specialist to play a key role in supporting our enterprise clients and scaling internal support operations. You'll manage advanced tickets, configure and optimize Zendesk (including AI workflows), and help design onboarding and process documentation. You'll also work closely with Product and Developers to address...

  • Senior Growth Specialist

    2 days ago

    Prague, Hlavní město Praha, Czech Republic Global Accelerator Full time $76,000 - $100,000 per year

    SENIOR GROWTH SPECIALIST Our Mission is to be able to say - "Anyone in the World below $15M should fire their Agency tomorrow as nobody can beat this Value & Service at this Price" We are looking for a Hard-Working & Results-Driven Senior Growth Specialist to join the team. The Senior Growth Specialist position at Common Thread Collective (CTC) plays a...

  • Senior Technical Support Specialist

    2 days ago

    Prague, Hlavní město Praha, Czech Republic TransPerfect Full time €60,000 - €80,000 per year

    We're hiring a Senior Technical Support Specialist to play a key role in supporting our enterprise clients and scaling internal support operations. You'll manage advanced tickets, configure and optimize Zendesk (including AI workflows), and help design onboarding and process documentation. You'll also work closely with Product and Developers to address...

  • AtR Senior Specialist

    20 hours ago

    Prague, Hlavní město Praha, Czech Republic EPIROC Full time 104,000 - 130,878 per year

    Accounting to Reporting SpecialistYour Mission:Ensure the delivery of quality Accounting to Reporting (AtR) services to the entities in scope in line with Service Level Agreements and the Epiroc Way as well as business requirements.Senior AtR Specialist will be responsible for standardization and harmonization of processes with one ERP system. Will lead a...

  • Senior People Specialist

    2 days ago

    Prague, Hlavní město Praha, Czech Republic Anheuser-Busch InBev Full time 400,000 - 600,000 per year

    Seniority Level:TalentBrewing the world's most loved beers and building brands consumers love, AB InBev is where ownership, ambition, and action thrive. We empower you to dream big, lead change, and create a long-lasting legacy. We value relentless problem-solvers who take accountability, embrace challenges, and turn bold goals into results through...

  • Senior People Specialist

    2 days ago

    Prague, Hlavní město Praha, Czech Republic AB InBev Full time €40,000 - €60,000 per year

    Seniority Level:#TalentBrewing the world's most loved beers and building brands consumers love, AB InBev is where ownership, ambition, and action thrive. We empower you to dream big, lead change, and create a long-lasting legacy. We value relentless problem-solvers who take accountability, embrace challenges, and turn bold goals into results through...

  • Finance Master Data Senior Specialist

    2 days ago

    Prague, Hlavní město Praha, Czech Republic Novartis Full time 900,000 - 1,200,000 per year

    SummaryGFMD Senior Specialist role provides quality services to Novartis Group entities and is responsible for executing the maintenance of master data used in Novartis, on behalf of internal and/or external customers.GFMD Senior Specialist is responsible for the daily operations, high quality of the service as well as timely processing of the master data...

  • Senior Regulatory Affairs Specialist

    2 days ago

    Prague, Hlavní město Praha, Czech Republic Zentiva Full time 600,000 - 800,000 per year

    POSITION PURPOSEAs the Senior Regulatory Affairs Specialist, you will be responsible for the preparation, submission, and maintenance of regulatory documentation in compliance with applicable legislation. You will coordinate cross-functional efforts to support product registrations and ensure ongoing compliance throughout the product lifecycle. This position...

  • Communications Specialist

    2 days ago

    Prague, Hlavní město Praha, Czech Republic Planet Pharma Full time 600,000 - 800,000 per year

    Communications Specialist (Strategic Focus) Location: [Prague] | Full-Time | Hybrid/Remote Options Available Are you a strategic communicator with a passion for impactful storytelling and stakeholder engagement? We're looking for a dynamic Communications Specialist to join our team and lead initiatives that shape internal and external narratives across...