The Regulatory Operations Manager role presents an exciting opportunity at the nexus of regulatory Operations. Responsibilities include serving as the contact person for Regulatory Operations in the product database, keeping the Registration Management System updated and in line with the authority requirements, supporting EVMPD data management, and ensuring compliance with IDMP standards, PMS/PML portal. Coordination of a small team and accountability for the related tasks. The ideal candidate has relevant experience, a background in Pharma or a related field, a sense of ownership and drive, a proactive approach to complex tasks, familiarity with EU regulations, proficiency in strong English skills. Join us to make a significant impact in the dynamic field of regulatory operations.
A Challenging Task
- Lead, mentor, and develop a small Regulatory Operations team, fostering collaboration and continuous improvement.
- Oversee regulatory master data management and ensure accuracy and integrity of data used for regulatory submissions and reporting.
- Maintain and optimize the Registration Management System (RIMS) in line with health authority requirements.
- Ensure compliance with IDMP/SPOR standards, xEVMPD requirements, PMS/PML portals, and other applicable regulatory guidelines.
- Drive process optimization and digitalization initiatives across Regulatory operations.
- Serve as Industry User Administrator for EMA Account Management Portal and related regulatory systems.
- Manage user access and support onboarding activities for PLM (eAF), ePI, and future EMA digital projects.
- Provide operational support for electronic regulatory Operations and pharmacovigilance systems.
- Develop and deliver training programs, workshops, and user guidance for RIMS and associated systems.
- Coordinate data governance activities and support validation of computerized systems
Who We Are Looking For
- A proactive and detail-oriented professional who enjoys working at the interface of Regulatory Operations and IT.
- A collaborative leader with excellent communication and stakeholder management skills.
- Someone who thrives in a dynamic environment and enjoys solving complex operational and data-related challenges.
- An individual with a strong sense of ownership, accountability, and continuous improvement mindset.
- A professional who is passionate about digital innovation and regulatory excellence.
A Convincing Background
- M.Pharmacy or other relevant qualification in Life Sciences, Pharmacy, Regulatory Affairs, Information Management, or a related discipline.
- 12–18 years of experience in Regulatory Operations, Regulatory Information Management (RIM), or related regulatory systems and processes.
- Proven experience in leading teams and managing cross-functional projects in a global regulatory environment.
- Strong knowledge of Data Governance, IDMP/SPOR, xEVMPD, PMS/PML Portal, and regulatory compliance requirements.
- Hands-on experience with Regulatory Information Management Systems (RIMS), eDMS, eCTD Manager, eArchive, and other regulatory platforms.
- Experience in computerized system validation, vendor management, and digital transformation initiatives.
- Sound understanding of EU regulatory requirements and health authority expectations.
- Excellent communication, stakeholder management, and problem-solving skills.
- Proficiency in MS Office applications and strong written and verbal English communication skills.
Which mindset will you meet at Tiefenbacher
- We strive towards developing curious team members from all over the world who love to challenge the status quo, take on responsibility, enjoy collaborating and have an affinity and passion for health care. At all Tiefenbacher Group companies, you will meet a fast-paced work environment where everybody is welcome to suggest new ideas and take ownership of their realization. On a daily basis, we are working towards a culture characterized by curiosity, high energy levels and openness to mutual feedback. We also value a good sense of humor and optimism, especially during hectic times.