Regulatory Affairs Executive

Job ID

23639

Position Title

Regulatory Affairs Executive

Industry

Healthcare/Medical/Biotechnology/Pharmaceutical

Job Description

• Liaise with the government office, authorities, and regulatory consultant(s) on matters pertaining to regulatory activities, licenses, and permits to develop new and existing products including drugs, medical devices, general goods, food, and cosmetics.
• 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.
• Review technical dossier of new products application and prepare additional documents where necessary to ensure a smooth register.
• Conduct timely approval of new product.
• Conduct renewal of existing product licenses, manufacturing site qualification, post-approval variations, and other applications in accordance with requirements of the government office.
• Maintain appropriate GDP for drugs, medical devices, and cosmetics.
• Evaluate the existing supply chain and advise on necessary changes to meet the guidelines.
• Manage and lead the implementation of various GDP training modules and programs.
• Manage and respond to internal and external regulatory audits.
• Handle post-marketing activities and pharmacovigilance, reporting requirements of company and product licenses to the government periodically or when required.
• Review advertising, package labeling, and promotional items to ensure regulatory compliance and advise marketing staff at local or Japan, if necessary.
• Register and renew the company licenses.
• Prepare a monthly report on pharmacovigilance for the head office and report it to the President.
• Provide guidance to project team members regarding regulatory compliance issues by maintaining an up-to-date understanding of government office regulations and organizational structure and potential changes.
• Build and maintain relationships with key regulatory officials influencing regulations to achieve positive and timely outcomes for product approvals.
• Collect data relevant to any regulatory questions, issues, or problems and resolve them quickly.
• Participate in monthly idea meetings when necessary and propose ideas for new products several times a year.
• At the request of the head office, prepare the regulatory procedures and necessary documents for applying to other countries.
• Identify regulatory process improvements and work to improve and implement robust processes.

Salary

7000~8000 (RM)

Location

Kuala Lumpur

Requirements

• At least 3 years working experience in Regulatory Affairs related roles.
• Business Trip Frequency: As necessary, up to 2 times a month.
• Bachelor's degree in Pharmacy or related discipline.
• Language Requirements:
  - Bahasa Melayu - Written & Spoken - Native - Required
  - English - Written & Spoken – Business level - Required
• Pharmacist Certification – Preferred.
• Required to visit government office to appeal and submit applications.
• Possibility to have business trips.
• Functional Skills:
  - Create submissions and technical reports.
  - Identify gaps in the evidence base supporting submissions.
  - Explain key aspects of the healthcare product’s development process.
  - Advise on risk-based approaches, as appropriate.
  - Review labeling and advertising for regulatory compliance.
  - Implement quality systems to support regulatory processes.
  - Review regulatory submissions.
• Soft Skills Competencies:
  - Interpersonal skills.
  - Communicate clearly and effectively with the team and across departments.
  - Self-motivated and good team player.
  - Presentation Skills.
  - Relationship development with government officials.
  - Negotiation.
• Specific Knowledge Knowledge Area:
  - Knowledge of pharmacy.
  - Knowledge in FMCG products.
  - Knowledge of the laws relevant to products, packaging, and containers.