Regulatory Affairs Manager – Data Management

Barcelona onsite role - 3 days at office/3 days at home

Introduction to role

The Regulatory Affairs Manager – Data (RAMD) is a regulatory specialist with project management capabilities responsible for providing dedicated support for regulatory data management, with a particular focus on the Portfolio Overview Regulatory Tool (PORT) across the regulatory community. This includes ensuring the consistent use of PORT across the group and holding others accountable for the GRET data entry, in conjunction with the LRPMs, line managers, SDTLs, and RADs. They are a point of contact for training needs, questions, and feedback for the RAMs as they deliver end-to-end planning, coordination, and execution of assigned deliverables. They also manage the interface with IT, reporting issues and tracking these to ensure full resolution and requesting enhancements and improvements for the longer term. The RAMD also supports the effective visualization of PORT data and the regulatory data held in any integrated or connected tools such as APOLLO to meet the needs of GRETs, GRSTs, and multiple stakeholders across Regulatory and across the TAs, working flexibly within and across regions.

Accountabilities

Training:
- Point of contact for questions and feedback, providing consistent and dedicated support for technical matters and issues.
- Coaches, mentors, and holds regulatory team responsible for data entry.
- Owns short training videos, frequently asked questions (FAQ) document, and guides for hints and tips on using PORT.
- Supports GRETs in providing visualization of the submission delivery plans, agency interactions, and other regulatory visualization as needed.
- Organizes and facilitates trainings and awareness.
- Supports APOLLO roll-out once linked with PORT and other systems.

Communication:
- Actively promotes the use of PORT within ORSS.
- Shows efficient approach in embedding PORT in ways of working.
- Employs excellent communication skills, with the ability to build effective and collaborative working relationships with RAM group members for data entry and updates to time and quality.
- Performs data quality checks via Data Quality Dashboard and coordinates and communicates outcomes from other regular PORT data checks and follows-up.
- Keeps Regulatory up-to-date with changes in PORT via preparing communications and posting in Workplace or equivalent.
- Owns creation of general inbox, Workplace, and SPOL.

Development/Enhancement:
- Organizes and facilitates collaboration with IT, if required.
- Works closely with LRPMs, RAMs, and RADs if required, to identify blockers or issues for maintaining and using PORT, and opportunities for improving via escalation to LRPMs and PORT team, as appropriate.
- Maintains a list of PORT development and enhancement recommendations (logging and tracking).
- Contributes to process improvement activities across the RAM group, where PORT or other tools can offer a digital solution or provide benefit.

PORT User Access:
- Supports PORT team in establishing and troubleshooting PORT Access/Security levels within ORSS.
- Point of Contact for PORT User Access requests.

Other:
- Active member of PORT team and pro-active expert in data management for PORT.
- Provides administrative support for PORT team (e.g., PORT Team general email [PORT Support Team], maintenance of PORT workplace, maintenance of PORT landing page (SharePoint, Nucleus or equivalent), etc).

Essential Skills/Experience
- Relevant University Degree in Science or related discipline or equivalent relevant regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience
- General knowledge of drug development
- Strong project management skills
- Leadership skills
- Stakeholder management skills

Skills and Capabilities
- Highly proficient user and ‘Subject Matter Expert’ for PORT with extensive ‘hands-on’ experience and proven ability to train others
- General knowledge of Regulatory systems and tools and an understanding of how other business systems connect and feed into PORT e.g., PLANIT, APOLLO
- Proficiency with common project management (e.g., MS Project) and document management tools
- Excellent written and verbal communication skills
- Cultural awareness
- Ability to work independently and as part of a team
- Influencing and stakeholder management skills
- Ability to analyze problems and recommend actions
- Continuous Improvement and knowledge sharing focused

Desirable Skills/Experience
- Regulatory experience with a focus on delivery and execution
- Understanding of regulatory deliverables at the project level
- Knowledge of AZ Business, processes, and systems

At AstraZeneca, we are driven by our mission to push the boundaries of science to deliver life-changing medicines. Our innovative environment fosters creativity where questioning minds never settle until new insights are uncovered. We embrace diversity, drawing on different perspectives to unlock industry-leading growth. Our commitment to lifelong learning ensures that you will have opportunities for growth and development. Join us in our quest to solve complex healthcare challenges while making a meaningful impact on patients' lives worldwide.

Ready to make a difference? Apply now!