Regulatory Affairs Specialist

2 weeks ago

Petaling Jaya, Selangor, Malaysia Dexian Asia Pacific Full time
:

Job Purpose

To contribute as an integral member of Malaysia RA team to support all regulatory activities for 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
  1. Prepares submission dossiers for post-approval variations within agreed timelines.
  2. Maintains general knowledge of latest regulatory requirements.
  3. Establish and maintain good working relationship 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 database(s) as required.
  2. Maintain and update regulatory files and records as required.
  3. Ensures compliance with local regulations, corporate policies and procedures.
  4. Prepares and verifies 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. 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.
  3. Collaborates with Global RA functions on regulatory support whenever required.

Ideal Background

  1. A minimum of diploma in health-related science or pharmaceutical science desired.
  2. 1 year of experience in regulatory affairs or related work experience.
  3. Proven track record of preparing, reviewing and managing regulatory applications successfully.
  4. Good knowledge and understanding of pharmaceutical & scientific processes.
  5. Good understanding of local regulatory environment, guidelines and processes for product registration.
  6. Computer literacy with knowledge of MS Office applications.
  7. Able to manage data and statistics.
  8. Good interpersonal, organizational, negotiation and problem-solving skills.
  9. Excellent verbal and written communication skills.

Personal Attributes

  1. A self-starter and have a hands-on approach and a strong "can-do" attitude.
  2. Ability to work independently.
  3. Results oriented, entrepreneurial and self-motivating.
  4. Bias for action, capability to define, evaluate and take risks.
  5. Commercial understanding of corporate and operational business issues.
  6. Possess excellent organizational skills.
  7. Openness to change and ability to think out of the box.
  8. Proactive in identifying challenges and developing appropriate solutions.
  9. Possess a high level of business ethics, integrity and professionalism, and the ability to ensure those standards are reflected in the business dealings.
  10. Global mindset and experience working in a global, multi-national pharmaceutical company.
  11. Ability to work under changing environment.
  12. Ability to manage ambiguity and incertitude.
Seniority level
  • Associate
Employment type
  • Contract
Job function
  • General Business, Administrative, and Health Care Provider
  • Industries: IT Services and IT Consulting and Pharmaceutical Manufacturing
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