Senior xEVMPD/IDMP Regulatory Specialist

Michael Page; Lisboa; On-site; EUR 60,000 - 90,000; Full time

Job summary

Michael Page, a global healthcare-focused company, seeks a Senior Specialist for xEVMPD/IDMP coordination. You will monitor Veeva RIM for submissions, liaise with Regulatory Leads and third parties, and maintain data quality for Health Authority submissions from Lisbon.

The role emphasizes cross-functional collaboration in a fast-paced environment. Successful candidates have a Bachelor's in Life Sciences and at least 4 years in Regulatory Operations, with strong English communication and

Qualifications

• Bachelor's degree or equivalent in Life Sciences, Scientific Affairs, Information Management, Business Administration, or a related field.
• Minimum of 4 years of experience within the pharmaceutical industry, Regulatory Operations, Regulatory Affairs, or Regulatory Data Management.
• Strong experience with xEVMPD and/or IDMP processes and regulatory data management.
• Experience with xEVMPD/IDMP software and related data management tools (e.g. Veeva) is strongly preferred.
• Experience with Veeva RIM or similar Regulatory Information Management systems.
• Familiarity with document management systems such as Veeva Vault, D2, or equivalent platforms.
• Strong attention to detail with a focus on data quality and compliance.
• Ability to manage multiple priorities and deadlines in a fast-paced, cross-functional environment.
• Excellent communication, analytical, and problem-solving skills.
• Proficiency in spoken and written English is required.

Responsibilities

• Monitor the Veeva RIM system for submissions that require xEVMPD reporting.
• Communicate with Regulatory Leads and Third Party companies to obtain all information required to complete the xEVMPD submissions in a timely manner.
• Maintain xEVMPD (Article 57) relevant data utilizing Veeva RIM and submit data to Health Authorities, while ensuring data quality and compliance with submission timelines.
• Assist with generation of reports and reconciliation of xEVMPD data with Regulatory Leads and Affiliates as required.
• Assist with responses to Health Authority questions related to xEVMPD data as required.
• Assist with the Annual PV Fee Advice Note review with the EEA Affiliates, ensuring that corrective actions have been implemented in the xEVMPD database as instructed by the Affiliates.
• Maintain proficiency with xEVMPD/IDMP related business processes, Veeva RIM software and Health Authority requirements.
• Work in conjunction with the Learning and Development team to provide subject matter expertise to support the creation of training and educational material.
• Provide input into the creation of Standard Operating Procedures, Work Instructions and Job Aides as appropriate for relevant business processes and systems.
• Support the Regulatory Operations Systems Support team to suggest, review and implement changes to existing business tools and systems.
• Collaborate as a member of internal project teams to identify and resolve issues while developing opportunities to reduce inefficiencies through new and/or improved IT solutions, business processes or tools.
• Perform other duties as assigned consistent with the grade of the role.

Skills

Regulatory data

xEVMPD/IDMP

Veeva RIM

Documentation systems

English proficient

Communication

Analytical thinking

Prioritization

Problem solving

Education

Bachelor's in Life Sciences

Tools

Veeva Vault

D2

Veeva

Job description

Michael Page, a global healthcare-focused company, seeks a Senior Specialist for xEVMPD/IDMP coordination. You will monitor Veeva RIM for submissions, liaise with Regulatory Leads and third parties, and maintain data quality for Health Authority submissions from Lisbon.

The role emphasizes cross-functional collaboration in a fast-paced environment. Successful candidates have a Bachelor's in Life Sciences and at least 4 years in Regulatory Operations, with strong English communication and