Job description
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
Responsibilities & skills
Education
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
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
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Roche
Roche was one of the first companies to bring targeted treatments to patients. With our combined strength in pharmaceuticals and diagnostics, we are better equipped than any other company to further drive personalised healthcare. Two-thirds of our Research and Development projects are being developed with companion diagnostics.We are the world's number 1 in biotech with 17 biopharmaceuticals on the market. Over half of the compounds in our product pipeline are biopharmaceuticals, enabling us to deliver better-targeted therapies.We have been at the forefront of cancer research and treatment for over 50 years, with medicines for breast, skin, colon, ovarian, lung and numerous other cancers.We offer doctors profound information to guide treatments and to answer more patients’ questions than any other company. And our tests enable hospitals and labs to deliver that information quickly and reliably.We invest around 9 billion Swiss francs in Research and Development every year because innovation is our lifeblood. This is amongst the highest Research and Development spends in the world across all industries.
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