This position will be contributing positively to patients through strategic planning, execution and management of life-cycle submissions for assigned Roche products by ensuring alignment and compliance against local registration requirements as well as with company policies.Reports to Medical, Innovation and Regulatory Affairs Chapter Lead.The Opportunity:Develop innovative, risk-based registration plans and submissions strategies across the entire product lifecycle to ensure timely regulatory filings and approvals.Provide regulatory expertise and input into cross-functional affiliate business strategies.Manage end-to-end local product packaging and labelling from a regulatory perspective.Ensure regulatory compliance for product released to market and regulatory inspection- readiness for the Affiliate, as per assigned responsibilitiesResponsible and accountable to ensure SOP is updated as per required on a timely manner.Responsible as Company Pharmacist for regulatory compliance on Poison License and other pharmaceutical related regulations 

Fluency in written and spoken English and Bahasa Malaysia. Ability to influence individuals or groups at more than one level who mayPurpose-driven, passionate to make an impact to patients and society. Strong self-organization and high achiever. Meticulous with an eye for details.Takes responsibility, drives results and achieves expected outcomes.

Experience in a regulatory affairs role in a pharmaceutical environment, with a minimum of 5 years.Degree in Pharmacy, eligible to hold the relevant pharmaceutical permits/licenses for the company. Accreditation by the relevant authority with the Ministry of Health, Malaysia