Regulatory Records Associate

Major accountabilities:

• Under the supervision of Head, RA Ops Mergers and Acquisitions, support assigned tasks related to the areas of archiving, retention, and timely disposition of impacted Regulatory Records.
• Receives, tracks, and responds to inquiries and requests for retrieval of stored RA records in a timely manner.
• Responsible for receiving, classifying scanning, indexing, and archival of regulatory relevant records in support of MA&D activities.
• Ensure timely generation of reports; assist Operational team in developing and maintaining meaningful KPI’s/metrics related to physical and electronic record transfers.
• Participate in the development and review of line function related records management processes and procedures.
• Provide audit support related to RA records managed by RA Operations , including support for MA &D related needs.
• Support, as per guidance from RA Ops M&A team, the litigation team on document discovery requests (due diligence); assist in legal hold implementation as per Legal Department needs
• Collaborates with RA Operational team in development, implementation, communication, training and enforcement of Regulatory Records Management best practices.
• Proactively identify opportunities for operational process or system related improvements relevant to both paper and electronic records management.

Key performance indicators:

• Flexible, proactive, with demonstrated attention to detail and accountability for deliverables as well as proven ability to work in a fast-paced team / matrix environment or independently as needed.
• Results driven, action oriented, highly motivated, self-starter and forward thinker.
• Ability to effectively collaborate with internal/external partners, stakeholders, peers and colleagues in a multi-cultural, global environment.
• Strong organizational and time management skills to help plan activities and manages tasks and timelines with efficiency while navigating competing and complex priorities.
• Demonstrated skills to understand complex discussions, has a positive attitude and follow directions to help develop/implement innovative solutions.
• Able to effectively adjust to constant change and related challenges, is decisive and composed under pressure.
• Adherence to Novartis policy and guidelines -Project & stakeholder feedback

Minimum Requirements:
Education:

• BS or MS degree with 3+ years of Regulatory and/or Archives/Records management experience within Pharmaceutical industry.

Work Experience and Skills:

• 3+ years’ experience in Pharma (preferably in the area of Regulatory Records
• Management) is preferred.
• Familiar with drug development process, worldwide regulatory practices, electronic submission guidelines and requirements as well as records/document management processes
• Hands-on experience with regulatory records or document management systems and related software/tools preferred
• Working knowledge of regulatory affairs.
• Project management and time management skills to manage multiple ongoing projects simultaneously.
• Proficiency with computer programs/systems (MS office, etc.) with demonstrated ability to learn new systems quickly.
• Works independently and with minimal supervision.
• Good analytical and problem-solving skills.
• Ability to coordinate and work effectively with cross-functional teams.

Languages :

• English.