Regulatory Affair Executive

**REGULATORY AFFAIRS EXECUTIVE** *** The Regulatory Executive manages product and company license renewals with government agencies and ensures compliance with local laws and regulations. The role also monitors regulatory changes and updates management to prevent business risks. **RESPONSIBILITIES** **1. Regulatory Affairs & Compliance** - Prepare,...

Responsibilities: -Assist in ensuring company compliance with Medical Device Authority (MDA) requirements.Support in Establishment Licensing and Medical Device Registration matters.Liaise with overseas manufacturers for regulatory documentation.Assist in the renewal of certificates and licenses accurately and on time.Maintain and update regulatory records...

**Key Responsibilities**: **1. Regulatory services & Pharmacovigilance & handling of controlled drug** - Review and approve marketing and promotion materials. Handle registration and maintain database of sales and advertisement permits issued by relevant authority bodies. - Responsible for the Regulatory Affairs (RA) functions and team members. - Provide...

Link, part of the Clinigen Group, is a rapidly growing global specialty pharmaceutical services business with a unique combination of services across the pharmaceutical lifecycle. We currently have over 1,000 employees headquartered in the UK with global offices in the US, UK and EU, Asia Pacific and South Africa. We're growing rapidly and well positioned...

Location : Seksyen U1, Shah Alam Salary : RM 3,500 - 5,500 **Key** Responsibilities**: - Responsible for the regulatory and compliance requirements for the products under the group of companies. - Ensure regulatory compliance by proactively monitoring, interpreting, implementing and conveying global and regional regulations that impact products and local...

1. Regulatory services & Pharmacovigilance & handling of controlled drug- Review and approve marketing and promotional materials to ensure compliance with relevant guidelines and standards.- Manage registration processes and maintain an up-to-date database of sales and advertising permits issued by the appropriate regulatory authorities.- Responsible for...

Assist General Affairs team, including training, performance evaluation, and goal setting. - Monitor & practicing policies, procedures, and initiatives to improve overall administrative efficiency. - Manage office facilities, including space planning, maintenance, and security to ensure a safe and conducive work environment. - Ensure a safe, clean, and...

Job Purpose1.To provides regulatory, scientific and nutrition support to the business unit.2.The incumbent keeps abreast of local & oversea countries regulatory knowledge.Key Accountabilities1.Ensure raw material, product recipe / formulation, label and communication material compliance to the regulatory requirement of Malaysia, Brunei and other markets as...

Responsible for product registration of cosmetic and personal care by NPRA - Prepare documentations for GMP, HALAL and ISO 9001 audit - Maintained departmental quality documents (standard operation procedure, working instructions, etc) to ensure comply with regulations set by GMP, HALAL and recognition set by ISO certification. - Responsible for internal...

New product registration and regulatory filling plan for OEM Products including pharmaceutical products, medical devices, FMCG, etc. (MAL, MDA NOT and Food), in Southeast Asian countries. - Functional regulatory representative of the OEM Products manufactured by third-party (OEM) manufacturers to support regulatory submission and approval. - Coordinated and...