Degree in relevant technical area (Analytical, Biochemistry, Biology, Pharmacy, among others).
At least 3-5 years of experience in the pharmaceutical industry.
Proven experience in Regulatory Affairs with focus on CMC requirements for small molecule / biologic products, development, manufacturing and / or quality assurance experience would be an asset.
Knowledge of ICH and cGMPs, global regulations and health authority guidance.
Ideally fluent in 1-2 languages spoken in the region of responsibility, in addition to English.
Ability to travel up to 10%.
Objetivo de la posición
This position is responsible for execution of Renewals submissions for all Roche products through developing and implementing robust end to end strategies of the local filings based on global 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.
PTR (CMC) contact for International Markets Renewals filings who through partnering with global Pharma Technical Regulatory (PTR) teams helps to develop and execute regulatory filing strategies for renewal approvals by Health Authorities.
Act as subject matter expert in CMC regulatory requirements for submissions and assure maintenance of regulatory requirements for regional markets under responsibility.
In collaboration with PDR ERAS, help to develop and execute objectives and plans toward aligning one global regulatory voice / outlook to affiliates in the region.
Support departmental operational excellence and business process initiatives.
Is responsible to define path to organize the process under which renewals will be performed either by Submission Expert or outside the system.