The position is responsible for execution of regulatory CMC (Chemistry Manufacturing Controls) submissions for all Roche products through developing and implementing robust end to end strategies of the international markets local filings based on the global development plan, global/ regional/ local business priorities, local regulatory requirements and landscape to accelerate drug access and continuous supply to the patients by ensuring right first- time submissions to Health Authorities.
As primary duties and responsibilities, Pharma Technical Regulatory (PTR) CMC will be an expert for International Markets filing through partnering with global PTR Teams, develop and execute regulatory filing strategies for initial marketing applications and life cycle management submissions toward maximizing efficiency, quality and rate of submission approvals by Health Authorities.
Liaise with Regional Supply Chain, Quality, and Affiliates DRA for development and execution of PT strategy roadmap, maximizing and balancing regulatory and supply needs in the region and enabling, priorization of change management activites.