This role is for one of the Weekday's clients
Min Experience: 8 years
Location: Europe
JobType: full-time
We are seeking an experienced Senior Regulatory Information Management (RIM) Specialist with deep expertise in Ennov RIM to support global regulatory operations for pharmaceutical, biotechnology, or life sciences organizations. The ideal candidate will play a critical role in managing regulatory data, submissions, and dossiers across the product lifecycle while ensuring compliance with global health authority requirements. This role requires strong functional knowledge of regulatory processes, hands-on system expertise, and the ability to collaborate with cross-functional stakeholders.
Requirements
Key Responsibilities
- Act as a subject matter expert (SME) for Ennov RIM, supporting configuration, maintenance, and optimization of RIM modules including Registration, Dossier, Submission, and Lifecycle Management.
- Manage end-to-end regulatory information management processes, ensuring accuracy, completeness, and consistency of regulatory data across regions.
- Support global regulatory submissions and lifecycle activities including IND, NDA, BLA, MAA, variations, renewals, and post-approval changes.
- Ensure compliance with global regulatory standards and health authority requirements (FDA, EMA, MHRA, PMDA, and other regional agencies).
- Collaborate with Regulatory Affairs, Quality, IT, and external vendors to streamline RIM workflows and improve system usability.
- Drive data governance, master data management, and controlled vocabularies within Ennov RIM.
- Support system upgrades, validations, and enhancements in alignment with GxP and 21 CFR Part 11 requirements.
- Develop and maintain SOPs, work instructions, and training materials related to RIM processes and systems.
- Provide user support, troubleshooting, and training to ensure effective adoption and utilization of Ennov RIM.
- Participate in audits and inspections by ensuring system readiness, data traceability, and compliance documentation.
Required Skills & Experience
- 8–12 years of experience in Regulatory Information Management within the pharmaceutical, biotech, or life sciences industry.
- Strong hands-on experience with Ennov RIM (mandatory), including regulatory data, submissions, and lifecycle management.
- In-depth understanding of global regulatory frameworks, submission standards (eCTD), and regulatory operations.
- Experience working in GxP-regulated environments with knowledge of validation and compliance requirements.
- Proven ability to manage complex regulatory data and multiple products across regions.
- Strong analytical, documentation, and problem-solving skills.
- Excellent communication and stakeholder management skills.
Preferred Qualifications
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field.
- Experience supporting RIM system implementations, migrations, or integrations.
- Exposure to other RIM or regulatory systems is a plus.
