Regulatory Affairs Manager III

Duration: 12+ Months

Part time 20 hours per week

This role is responsible for participating in cross-functional teams responsible for the development and life cycle management of combination products/devices. The candidate utilizes expertise to provide Regulatory CMC global regulatory strategy, support development activities and execute combination product submission deliverables.

This candidate must have proven leadership and abilities to work cross-functionally and across cultures. Strong communication, Regulatory CMC knowledge and interpersonal skills are required.

• Provides strategic and operational Regulatory CMC expertise and support in cross-functional teams, working flexibly within and across regions to provide broad operational support to ensure the delivery of project and business objectives.
• Participates in cross-functional teams responsible for development of combination products / devices.
• Ensures global regulatory CMC combination product / device strategy for assigned combination products are consistent with the team and business goals and meet Health Authority requirements.
• Ensures effective communication of CMC regulatory strategy, risks, and overall plans.
• Identifies supporting documents required for global submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.
• Prepares, authors and delivers applicable sections (IND/IMPD/CTAs/BLAs/MAAs) and full regulatory submissions (Notified Body Opinion). Responsible for submission from defining and agreeing content to leading reviews as required to ensure complete, concise and accurate submissions to Health Authorities.
• Authors and/or review of global CMC submission responses and supporting documentation to Health Authority questions in line with agreed global regulatory strategy and timelines.
• Provides input into Regulatory CMC risks assessment and mitigation plans and ensuring that it remains in line with the overall global Regulatory CMC strategy.
• Participates in cross functional workstreams and initiatives, as assigned by management

Education:

Bachelor’s Degree

Shift:

1st Shift M-F