Regulatory Affairs Pharmacist

Healol Pharmaceuticals; Kuala Lumpur; On-site; MYR 100,000 - 150,000; Full time

Job summary

A well-established pharmaceutical company with operations in Southeast Asia is seeking a Regulatory Affairs Pharmacist in Kuala Lumpur. The role involves managing regulatory licenses, ensuring compliance with health authorities, and providing training to staff. Candidates should have a Bachelor’s Degree in Pharmacy and relevant regulatory experience.

Benefits

Medical (GP and Hospitalisation)

EPF

SOCSO

Miscellaneous allowances

Qualifications

• Registered pharmacist with Pharmacy Board Malaysia.
• Experience in Regulatory Affairs within the pharmaceutical industry.

Responsibilities

• Apply TypeA Pharmacist License and maintain import/wholesale licenses.
• Liaise with NPRA and MDA regarding product registration and regulatory matters.
• Ensure timely submission of pharmaceutical product registrations.

Skills

Communication skills

Education

Bachelor’s Degree in Pharmacy

Job description

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Healol Pharmaceuticals Sdn Bhd is a pharmaceutical company established for last 30 years in South East Asia which specializes in Sales & Marketing of pharmaceutical products. We are a Malaysia based company and also have operations in Vietnam, Cambodia, Thailand, Philippines and Brunei. We are looking to hire a Regulatory Affairs Pharmacist to be based in Kuala Lumpur;

Qualifications & Experience

Bachelor’s Degree in Pharmacy.

Possess good communication skills in both English and Bahasa Malaysia.

Registered pharmacist with Pharmacy Board Malaysia.

Experience in Regulatory Affairs within the pharmaceutical industry.

Job Responsibilities

To apply TypeA Pharmacist License for the company, and to maintain import license, wholesale license etc. for company's operation.

Maintaining close liaison with National Pharmaceutical Regulatory Agency (NPRA) and Medical Device Agency (MDA), for all matters pertaining to product registration and regulatory.

To ensure timely submission of pharmaceutical products and/or medical devices' new registration, variation/change notification, re-registration, to ensure business is not interrupted.

To attend and/or participate in any post-registration activities such as post-market surveillances, customer enquiries, and regulatory-related pharmacovigilance activities (where applicable)

To maintain up-to-date knowledge of relevant regulations and guidelines, and to communicate regulatory information to related principals, departments, and Management.

To provide on-the-job training and guidance as and when required to staff to ensure they attain minimum competency to perform the required tasks.

Maintaining organized records of all regulatory documents, including registrations, poison records, compliance certificates etc., to facilitate audits and future submissions.

To provide support for both internal and external audits, i.e., GDP and GDPMD audits conducted by relevant Regulatory Authorities, including NPRA, MDA or other National Authorities, as and when required.

Any other duties that may be assigned by Management from time to time.

Medical (GP and Hospitalisation)

EPF

SOCSO

Miscellaneous allowances

Unlock job insights

Salary match Number of applicants Skills match

Your application will include the following questions:

• Which of the following statements best describes your right to work in Malaysia?
• What's your expected monthly basic salary?
• Which of the following types of qualifications do you have?
• How many years' experience do you have as a Regulatory Affairs Pharmacist?
• Which of the following languages are you fluent in?
• How would you rate your English language skills?
• Are you willing to undergo a pre-employment background check?
• How much notice are you required to give your current employer?

Healol Pharmaceuticals is a well-established 30 years old company in the pharmaceutical sales and distribution business operating in South East Asia region. We are based in Malaysia and have operations in Vietnam, Cambodia, Thailand, and Philippines.

The company was launched in 1994 in Malaysia and soon after started operations in other SEA countries.

Over the years, marketing infrastructure was developed in all the 5 countries that we operate in.

Our marketing staff strength in this region is over 400 well-trained professionals logistically placed to cover nearly 90% of the territories in each of these countries.

The company is financially sound, and operating profits are steady and rising.