Independently, provide and drive strategic and operational global CMC regulatory direction and documentation for complex projects / products involving medical devices and medical device / pharmaceutical combination products covering development, registration and approval / post approval activities.
take on additional assignments to influence global regulatory strategies and facilitate consistency within the CMC regulatory documentation by sharing experience through trainings within and outside Reg CMC.
Major activities :
The following tasks are to be performed as assigned :
Formulate, lead and drive global regulatory strategy for medical devices and medical device / pharmaceutical combination products throughout the product lifecycle, with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance.
Lead and drive all global submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects, while applying the global strategy into submissions (e.
g., 510(K), IDE, IND, CTA, IMPD, NDA, MAA, Drug / Device Master Files, Technical Files, Annual Reports, Amendments, Supplements, and etc.
Make quality regulatory decisions, balancing risks and benefits, while ensuring compliance with global medical device or combination product regulations / guidelines (ICH, ISO, IEEE, ASTM, etc.).
Initiate and lead interactions and negotiations with Health Authorities and Notified Bodies as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans.
Provide input on, and review specifications, process design controls, human factors study protocols, labeling, etc.
Lead, prepare and communicate CMC dossier risk analyses (SWOTS), contingency plans and Lessons Learned on major submissions and escalate to management as appropriate.
Keep knowledge up to date with regard to global regulatory requirements, guidelines, trends and processes for medical devices and combination products in all global regions as well as for new trends.
Represent Reg CMC on due diligence teams for in-licensing and divestment opportunities.
Provide training on critical regulatory points of medical device and medical de- vice / pharmaceutical combination product documentation and lessons learned within and outside the department.
Influence external regulatory environment to support company interests.
Support business objectives and lead initiatives within department and