JOB DETAILS

JOB DETAILJob Details

• Liaise with the government office, authorities and regulatory consultant(s) on matters pertaining to regulatory activities, licenses and permits to developing new and existing products. Products include 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 the 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 audit.

・Handle post-marketing activities and pharmacovigilance. Then report requirements of company and product licenses to the government periodically or when it is required.

・Review advertising, package labeling and promotional items to ensure regulatory compliance and give advice to marketing staff
at local or Japan, if it is necessary to amend copy or any explanations. Then obtain permits from government office and
authorities, 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

REQUIRED WORK EXPERIENCERequired

✓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. Specialty: Pharmacy or related discipline

✓Language　　
・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 labelling and advertising for regulatory compliance
・Implement quality systems to support regulatory processes
・Review regulatory submissions.
Certification Pharmacist Certification – Preferred
Other Requirements
Working Condition

Soft Skills Competencies
・Interpersonal skills
・Communicate clearly and effectively with the team and across departments
・Self-motivated and good team player
・Presentation Skill
・Relationship development with government officials
・Negotiation
Skills to:
・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 labelling and advertising for regulatory compliance
・Implement quality systems to support regulatory processes
・Review regulatory submissions.


Specific Knowledge Knowledge Area
・Knowledge of pharmacy
・Knowledge in FMCG products
・Knowledge of the Laws relevant to products, packaging and containers (e.g. Hazardous Substances Act, Act against
Unjustifiable Premiums and Misleading Representations, and Fire Service Act