Regulatory Compliance Specialist

2 weeks ago


Petaling Jaya, Selangor, Malaysia Dexian Asia Pacific Full time

Job Overview

Dexian Asia Pacific seeks a highly skilled Regulatory Affairs Specialist to join our Malaysia RA team. This role involves supporting all regulatory activities for products, including the development and implementation of regulatory strategies.

Main Responsibilities

Regulatory Strategy Development
  1. Develop submission dossiers for post-approval variations within agreed timelines.
  2. Maintain general knowledge of latest regulatory requirements.
  3. Establish and maintain good working relationships with internal and external stakeholders.
  4. Support investigation of regulatory compliance gaps with gap remediation plan development and implementation thereafter.
  5. Determine regulatory relevance and perform variation assessments.
Management of Regulatory Operations
  1. Develop and maintain regulatory databases as required.
  2. Maintain and update regulatory files and records as required.
  3. Ensure compliance with local regulations, corporate policies, and procedures.
  4. Prepare and verify monthly reports in addition to providing timely updates to relevant stakeholders.
  5. Receive, gather, assess, and process information received from assigned stakeholders.
  6. Provide administrative support where required.
Collaboration with Cross-functional Teams
  1. Support process improvements and implementation of best practices.
  2. Collaborate with Supply Chain Management (SCM), Quality Assurance (QA), and Patient Safety (PS) on shipment matters, quality matters, and safety communications when required respectively.
  3. Collaborate with Global RA functions on regulatory support whenever required.


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