Regulatory Affairs & Safety Assistant ManagerAs a Drug Safety Officer (DSO) of the company, lead the vigilance activities (such as AE reporting and submission of PBRER to local authority). Assist Regulatory Affairs Director in providing regulatory activities and product safety support for Reckitt products (Health category).
Lead the ongoing regulatory compliance, notification, and registration of Reckitt products.
Coordinate the resolution of regulatory, medical, and product safety issues affecting assigned Reckitt category in the country.
Support the Regulatory Affairs Director in providing regulatory affairs support and consultancy to internal and external customers in a business-oriented way.
Liaise with colleagues from Country marketing, R&D, supply, and global/regional regulatory teams, and work closely with external partners, contractors, and licensees to ensure that regulatory, safety, and medical affairs issues are properly managed and resolved.
Ensure the registration and regulatory compliance of Reckitt's marketed products with relevant national regulatory requirements to bring competitive advantage to our brands.
Compile registration dossiers for submissions to authorities.
Prepare, maintain, and update product registration/license and regulatory compliance files.
Amend registration dossiers as necessary for country-specific regulatory requirements and oversee the submission of registration/variation applications, negotiating with governmental authorities to obtain rapid approvals.
Monitor and interpret local regulatory issues and trends that will impact the marketability of company products, ensuring that the company is aware of significant local regulatory issues, and proactively lead the development and implementation of strategies to ensure regulatory compliance efforts that result in competitive advantage.
Manage the internal audit program from a regulatory and safety point of view.
Plan self-inspection schedules and supervise internal audits.
Lead internal investigations into allegations of non-compliance and coordinate the activities necessary to expeditiously resolve local regulatory disputes, assisting in the organization of internal audits and monitoring audits performed by third parties.
Communicate with Global Regulatory, Safety & Environmental Services (RSE), Global QA, and Regional and Local Quality Management on potentially serious product issues/product complaints. For serious product issues, ensure appropriate communication with local Regulatory Authorities after discussion with General Manager, Director, Regulatory Affairs Director - Malaysia, Global QA, Regional Quality Management, and other key stakeholders as necessary.
Requirements:
Language skills: Fluent in English and Malay.
Registered with Malaysia Pharmacy Board.
Minimum 5 years of experience in Pharmacovigilance (PV) in the pharmaceutical industry and Regulatory Affairs in FMCG or Healthcare.
Broad knowledge of Malaysia and East Asia regulatory and healthcare systems.
Experience in handling issue resolution in regulatory affairs.
Clear and logical thinker with the ability to recognize patterns and develop innovative solutions.
Proactive self-direction with a high level of initiative and persistence and a very hands-on approach to results delivery.#J-18808-Ljbffr