Freyr - Manager - Data Governance

Job Summary:

We are seeking an experienced Senior Professional with a strong background in Regulatory Data Management within the pharmaceutical industry. The ideal candidate will have 5-7 years of experience, including at least 5 years in regulatory data management and 3 years in the pharma domain. This role requires expertise in managing regulatory product lifecycle data, interpreting health authority requirements, ensuring compliance, and supporting business decision-making through accurate and efficient governance of regulatory information.

Key Responsibilities:

- Manage Regulatory Product Lifecycle data within Veeva Vault.

- Translate Health Authority requirements into regulatory database requirements.

- Review and interpret Health Authority guidelines and propose appropriate resolutions for process or system changes.

- Ensure compliance with GxP regulations and maintain quality standards in all regulatory data management processes.

- Identify and address gaps in regulatory processes to strengthen compliance and business outcomes.

- Collaborate with business stakeholders and cross-functional teams to track and manage registration data.

- Support regulatory operations and contribute to process improvements in product lifecycle management.

Required Skills & Experience:

5-7 years of overall experience, with at least:

- 5+ years in Regulatory Data Management.

- 3+ years in the pharmaceutical industry.

- Strong expertise in regulatory management databases (preferably Veeva Vault).

- Hands-on experience with GxP guidelines, compliance processes, xEVMPD, and IDMP.

- Project management experience in a collaborative team environment.

- Ability to work independently with a solution-oriented and investigative approach.

- Strong communication and stakeholder management skills.

Preferred Qualifications:

- Master's degree

- Veeva Vault Certification (mandatory).

- Experience in translating business knowledge into IT/data requirements for development.

- Familiarity with tools such as JIRA, SharePoint, and ServiceNOW.

Industry Experience:

- Proven experience with Veeva Vault application.

- Strong understanding of Regulatory Operations and Product Lifecycle Management.