A day in the life of a Director, Regulatory Affairs CMC Combination Products…
Provide accurate and timely device specific regulatory guidance to teams engaged in the development and lifecycle of drug device combination products and devices by assessing and interpreting global regulatory guidance’s and directives and evaluating and communicating their applicability to the development teams.
Support the development and communications of effective device and combination product platform related regulatory strategies for development and post marketing submission activities. Determine and communicate appropriate device and combination product related risk analyses and timeline development.
Collaborates with the Cross Functional Digital Health, Commercial, Quality, Combination Product development teams through progression of internal developmental programs.
Coordinate, support, author and/or review the Device platform specific agency interaction. Assist in the submission of regulatory correspondence to the agencies.
Assist in planning and conducting meetings with regulatory agencies and Notified Bodies to support Device related activities.
Review Device specific regulatory documents as needed. Including but not limited to Development Reports, Validation Protocols, standard operating procedures, test methods, specifications, protocols and reports, and responses to agencies information requests.
Support the Global Regulatory Affairs (GRA) CMC team for the global initiative for marketed products and assist with the preparation of a complete registration dossiers to be submitted to the Health Authorities.
Ensure global consistent change management and compliance of regulatory commitments.
Keeping oversight of Global Device related Regulations and providing consolidated training and consultancy to Subject Matter Experts (SMEs) and GRA.
Organizing and sharing of knowledge associated with medical devices.
Supporting GRA functions with and keeping central track /documentation of authority requests e.g. Notified Body Opinion, Commitments, categorization of products.
Ensuring adequate Change control and complaints management for devices /device components from a global RA perspective in collaboration with Quality Assurance (QA) and Pharmacovigilance (PV).
Ensuring adequate and efficient processes to obtain device specific documentation.
Leveraging synergies and harmonization across business units, functions and roles within GRA including establishing overarching work instructions/business practices
Representing Teva at Industry Associations and Conferences.
The Device Regulatory Affairs CMC Director is also responsible for maintaining and updating internal platform device strategy documents and Device relevant sections of submissions for Teva products.
Identify, propose, and implement improvements and simplification of processes in connection with other relevant functions and key stakeholders.
Advocate for harmonization in processes across the organization.
Participate in Quality/Regulatory governance meetings for managerial oversight of device compliance and change management.
Monitor regulatory compliance using applicable metrics and KPIs.
Who we are looking for
Do you have…?
Bachelor’s degree in scientific discipline (must have). Advanced degree (M.Sci., Ph.D., PharmD) is preferred.
Strong pharmaceutical and/or Device industry experience (must have)
Relevant technical experience in Combination Products, Digital Health Products, Analytical (QC, Analytical R&D), process/product development, or manufacturing is preferred.
Management experience in Regulatory Affairs.
Knowledge of ISO, US, EU and ICH Regulatory guidelines
Experience with eCTD regulatory filings.
Knowledge of US and global content and regional requirements
Knowledgeable in drug development processes and life cycle management of products
Clear, concise technical writing skills
Good interpersonal, communication and organizational skills.
Are you…?
Able to manage multiple projects and competing timelines.
Able to assess regulatory requirements and filing timelines in order to judge the work required for submission of a quality filing.
Able to assess technical quality of documents and to provide regulatory feedback to colleagues.
Able to respond quickly with reasonable solutions and alternatives to regulatory-related problems.
