Drug Safety Officer Lead
2 days ago
We protect, heal, and nurture in the relentless pursuit of a cleaner, healthier world. As a global health, hygiene, and wellness company, we strive to make access to highest quality hygiene, wellness, and nourishment a right, not a privilege.
About the JobThis role requires you to be the regulatory lead on pivotal projects, utilizing your exceptional communication skills to build strong partnerships and deliver critical tasks that drive our global presence.
Your Key Responsibilities- Act as Drug Safety Officer (DSO) and lead vigilance activities, ensuring timely reporting and submission of PBRER to local authorities.
- Support the Regulatory Affairs Director in providing regulatory activities and product safety support for Reckitt products in the Health category.
- Oversee ongoing regulatory compliance, notification, and registration of Reckitt products, and coordinate resolution of regulatory, medical, and product safety issues.
- Foster collaboration with colleagues from Country marketing, R&D, supply, and global/regional regulatory teams, and work closely with external partners to resolve regulatory, safety, and medical affairs issues.
- Ensure registration and regulatory compliance of Reckitt's marketed products with relevant national regulatory requirements.
- Develop and compile registration dossiers for submissions to authorities.
- Avoid common pitfalls in registration dossiers by amending them as necessary for country-specific regulatory requirements.
- Maintain awareness of local regulatory issues and trends impacting marketability of company products.
- Fluency in English and Malay.
- Registration with Malaysia Pharmacy Board.
- At least 5 years of experience in Pharmacovigilance (PV) and Regulatory Affairs in FMCG or Healthcare.
- In-depth knowledge of Malaysia and East Asia regulatory and healthcare systems.
- Proven track record in handling issue resolution in regulatory affairs.
- Strong analytical and problem-solving skills with ability to develop innovative solutions.
- Self-motivated individual with high level of initiative and persistence.
We prioritize the wellbeing of our people, investing in parental benefits, Employee Assistance Program, and life insurance for all employees globally. Our comprehensive benefits package aligns with local market standards.
Diversity and InclusionWe value diversity and inclusion, hiring candidates based on potential as well as experience. All qualified applicants will receive fair consideration for employment without regard to protected characteristics.
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