Regulatory Affairs Executive

22 hours ago

Kuala Lumpur, Kuala Lumpur, Malaysia Pasona Full time
Regulatory Affairs Executive Job Description

Position Title: Regulatory Affairs Executive

Job ID: 23639

Salary: 7000~8000 (RM)

Location: [Location not specified]

Job Responsibilities:

  1. Liaise with government offices, authorities, and regulatory consultants on matters pertaining to regulatory activities, licenses, and permits for developing new and existing products, including drugs, medical devices, general goods, food, and cosmetics.
  2. Develop and recommend the best regulatory strategy for submissions, including regulatory timelines, while discussing with the head office in Japan during the planning phase for new products to achieve timely and cost-effective clearance/approval.
  3. Review technical dossiers of new product applications and prepare additional documents where necessary to ensure smooth registration.
  4. Conduct timely approvals of new products and renew existing product licenses, manufacturing site qualifications, post-approval variations, and other applications in accordance with government requirements.
  5. Maintain appropriate GDP for drugs, medical devices, and cosmetics.
  6. Evaluate the existing supply chain and advise on necessary changes to meet guidelines.
  7. Manage and lead the implementation of various GDP training modules and programs.
  8. Manage and respond to internal and external regulatory audits.
  9. Handle post-marketing activities and pharmacovigilance, reporting requirements of company and product licenses to the government periodically or as required.
  10. Review advertising, package labeling, and promotional items to ensure regulatory compliance and advise marketing staff in local or Japan as necessary.
  11. Register and renew company licenses.
  12. Prepare a monthly report on pharmacovigilance for the head office and report it to the President.
  13. Provide guidance to project team members regarding regulatory compliance issues by maintaining an up-to-date understanding of government regulations and potential changes.
  14. Build and maintain relationships with key regulatory officials to achieve positive and timely outcomes for product approvals.
  15. Collect data relevant to any regulatory questions, issues, or problems and resolve them quickly.
  16. Participate in monthly idea meetings when necessary and propose ideas for new products several times a year.
  17. At the request of the head office, prepare regulatory procedures and necessary documents for applications to other countries.
  18. Identify regulatory process improvements and work to improve and implement robust processes.

Requirements:

  1. At least 3 years of working experience in Regulatory Affairs related roles.
  2. Bachelor's degree in Pharmacy or related discipline.
  3. Language requirements: Bahasa Melayu - Written & Spoken - Native (Required), English - Written & Spoken - Business level (Required).
  4. Pharmacist Certification – Preferred.
  5. Willingness to visit government offices to appeal and submit applications.
  6. Ability to undertake business trips as necessary, up to 2 times a month.

Functional Skills:

  1. Create submissions and technical reports.
  2. Identify gaps in the evidence base supporting submissions.
  3. Explain key aspects of the healthcare product's development process.
  4. Advise on risk-based approaches, as appropriate.
  5. Review labeling and advertising for regulatory compliance.
  6. Implement quality systems to support regulatory processes.
  7. Review regulatory submissions.

Soft Skills Competencies:

  1. Interpersonal skills.
  2. Clear and effective communication with the team and across departments.
  3. Self-motivated and a good team player.
  4. Presentation skills.
  5. Relationship development with government officials.
  6. Negotiation skills.

Specific Knowledge:

  1. Knowledge of pharmacy.
  2. Knowledge in FMCG products.
  3. Knowledge of laws relevant to products, packaging, and containers (e.g. Hazardous Substances Act, Act against Unjustifiable Premiums and Misleading Representations, and Fire Service Act).
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