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.
At Roche 94.000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we have become one of the world´s leading research- focused healthcare groups. Our success is built on innovation, curiosity and diversity. Know more about Roche Uruguay: www.roche.com.uy
Degree in relevant technical area (Analytical, Biochemistry, Biology, Pharmacy, among others).
At least 3- 5 years of experience in pharmaceutical industry.
Proven experience in Regulatory Affairs with focus on CMC requirements for small molecule/ biologic products. Hands on experience in any of the fields of development, manufacturing and/ or quality would be an asset.
Fluent written and spoken English and Spanish.
Will be valorate: knowledge of ICH and cGMPs, global regulatations and health authority guidance. Also Phd in relevant areas.