Regulatory Affairs Specialist | Pharmaceutical Industry

Position: Regulatory Affairs Specialist Industry: Pharmaceutical Working Duration: 12 months contract (Renewable based on performance) Working Location: Imazium, 8, Jalan SS21/37, Damansara Utama, 47400 Petaling Jaya, Selangor Working Day/Hours: Monday – Friday; 8:30am – 5:30pm Salary: Basic up to RM6,000 (Based on experience + skills) with statutory contribution + leave entitlement + medical insurance Job Purpose To contribute as an integral member of Malaysia RA team to support all regulatory activities for company products. This includes the development and implementation of regulatory strategies, including the review, preparation and health authority management of regulatory applications required to secure regulatory approval across various therapeutic areas, in alignment with core business objectives. Major Accountabilities Regulatory Strategy • Prepares submission dossiers for post-approval variations within agreed timelines. • Maintains general knowledge of latest regulatory requirements. • Establish and maintain good working relationship with internal and external stakeholders. • Support investigation of regulatory compliance gaps with gap remediation plan development and implementation thereafter. • Determine regulatory relevance and perform variation assessments. Management of Regulatory operations • Develop and maintain regulatory database(s) as required. • Maintain and update regulatory files and records as required. • Ensures compliance with local regulations, corporate policies and procedures. • Prepares and verify monthly reports in addition to providing timely updates to relevant stakeholders. • Receive, gather, assess, and process information received from assigned stakeholders. • Provide administrative support where required. Collaboration with cross-functional teams • Support process improvements and implementation of best practices. • Collaborates with Supply Chain Management (SCM), Quality Assurance (QA) and Patient Safety (PS) on shipment matters, quality matters (e.g. investigation of deviations and reporting them to relevant health authorities) and safety communications when required respectively. • Collaborates with Global RA functions on regulatory support whenever required. Job Requirement • A minimum of diploma in health-related science or pharmaceutical science desired. • 1 year of experience in regulatory affairs or related work experience. • Proven track record of preparing, reviewing and managing regulatory applications successfully • Good knowledge and understanding of pharmaceutical & scientific processes. • Good understanding of local regulatory environment, guidelines and processes for product registration. • Computer literacy with knowledge of MS Office applications. • Able to manage data and statistics. • Good interpersonal, organizational, negotiation and problem-solving skills • Excellent verbal and written communication skills. If you are interested to apply, please forward your latest resume to [email protected] or [email protected] Subject: Job Application – Regulatory Affairs Specialist