Senior Regulatory Specialist managing regulatory activities for pharmaceutical CMC projects. Collaborating with diverse teams and ensuring timely delivery of regulatory documentation and compliance.
About the role
- Regulatory expert leading global strategy and execution for digital medical devices at Novartis. Drive regulatory direction across development, registration, and post-approval ensuring compliance.
Responsibilities
- Develop and communicate digital medical device regulatory strategies for projects across the life cycle (Development and On-Market).
- Ensure digital device regulatory risks and key issues are communicated in a timely manner to project teams and other stake holders.
- Represent department in cross-functional project teams as appropriate.
- Provide Novartis technical and clinical functions clear, concise guidance on current digital device regulatory requirements to support planning and decision making.
- Lead and implement global digital device submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.
- Lead the identification of the required documentation and content, compliance and timelines issues for global digital device submissions and work collaboratively with cross-functional teams for the delivery of technical source documents in accordance with project timelines.
- Author and/or review compliant digital device documentation for HA submissions, applying agreed digital device global regulatory strategies, current regulatory standards and guidelines.
- Lead, prepare and communicate digital device risk management assessments, contingency plans, and lessons learned on major submissions and escalate as appropriate.
- Drive digital device related interactions with Health Authorities globally.
- Knowledge sharing, e.g. provide coaching within Regulatory Affairs and other functional areas.
- Development of new digital device regulatory guidance, policy, and processes.
Requirements
- Science Degree (e.g. Engineering, Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.
- Significant experience in the digital device industry or regulatory agency with responsibility for digital devices.
- Significant knowledge/experience in digital device regulatory submission and approval processes.
- Demonstrated practical experience in digital device regulatory affairs (e.g. IDE/510(k)/PMA filings; application of digital device quality management systems, software validation, human factors, design verification/validation requirements).
- Experience of leading regulatory health authority interactions, inspections and/or external advocacy/regulatory policy.
- Ability to critically evaluate data from a broad range of scientific disciplines.
- Knowledge of digital device development and life cycle management.
- Ability to work independently and successfully with global project teams and prioritize activities considering timelines and workload.
Benefits
- Commitment to Diversity & Inclusion
Job title
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Not specified
Degree requirement
Location requirements
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