Regulatory Affairs Manager

Responsibilities:Key Functions:Responsible for regulatory strategy, submissions and approvals for new product registrations, renewals, variations, and maintenance of registered products.Responsible to maintain local SOPs and ensure compliance with regulations are met.Responsible for providing input and approval on advertising/promotional materials for regulatory compliance.Provide support to commercial team from regulatory perspectives.Poison License Holder, company pharmacist.Primary contact with Regulatory Authority Department in the country.Regulatory :Product scope includes new molecules, generics, biosimilars, medical devices, diagnostics and OTC.Lead local regulatory work for pharma division including new product/ device registrations, variations and renewals.Conduct regulatory related submission/ correspondence with respective local health authorities (National Pharmaceutical Regulatory Agency NPRA and Medical Device Authority MDA).Develop registration strategies, implement regulatory plan and coordinate multiple projects and activities in accordance with strategic company objectives. Review, analyze and coordinate data for new product submissions, line extensions according to priorities. Ensure up-to-date product registration, variation, line extension and other related law & regulations knowledge.Ensure that the content complies with government regulations prior to submission to Regulatory Authority.Maintain an awareness of country’s regulatory legislation and assess its impact on company’s business.Liaise and negotiate with the relevant authorities to facilitate and secure expeditious regulatory approvals.Maintenance of regulatory related database and licences such as product technical files, product complaints and adverse drug reaction records, import and poison A licences, etc.Local SOPs and Policies :Prepare and maintain local SOPs and policies relevant to Regulatory Affairs to comply with NPRA and MDA requirements.Lead applicable regulations and standards including cGMP and Safety; Compliance topics and quality systems such as GDP, Change Control, Data Integrity, auditing, and Complaint Handling. Support Marketing Activities :Conduct strategy meetings with commercial team to discuss product pipelines and registration plans.Provide management with a monthly registration status.Provide regulatory input and support for marketing plans, product launches and other cross- functional activities.Review and provide input and approval on promotional materials, product information and labels for regulatory compliance.Pharmacovigilance (PV) and Quality Assurance (QA) Support :Lead local pharmacovigilance system in line with local regulatory requirements. Drive maintenance and preparation of local quality management system and internal audit in compliance to local regulatory requirements,Requirements:Qualifications :Bachelor’s degree in pharmacy.Registered pharmacist recognized by MOH Malaysia.Experience in regulatory affairs in a pharmaceutical or medical device company.Familiar with local regulatory bodies such as NPRA and MDA.Strong initiative and ability to take lead on projects.

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Regulatory Affairs Manager

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Regulatory Affairs Manager

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