RA/PV Pharmacist

Medispec (M) Sdn Bhd; Petaling Jaya; On-site; MYR 120,000 - 180,000; Full time

Benefits offered by this job

Medical insurance

Training and certification sponsored

Bonus and Long Service Award

Job summary

Medispec (M) Sdn Bhd is seeking a proactive Regulatory Affairs professional to join our RA team in Malaysia. You will manage product registrations with NPRA and MDA, oversee lifecycle of pharmaceutical and medical devices, and liaise with stakeholders to ensure regulatory compliance.

The ideal candidate holds a Pharmacy Degree, at least 5 years in regulatory affairs, and strong pharmacovigilance knowledge. English and BM communication skills are essential, and you must be a Malaysian citizen.

Qualifications

• A recognized Pharmacy Degree and registration with the Pharmacy Board of Malaysia.
• Minimum 5 years of experience in product registration with NPRA and MDA.
• Knowledge of Pharmacovigilance.
• Strong communication in English and Bahasa Malaysia.

Responsibilities

• Ensuring smooth regulatory operations in the RA department
• Managing the lifecycle of pharmaceutical products and medical devices
• Liaising with external and internal stakeholders
• Handling Pharmacovigilance in the company
• Keeping up to date with current regulatory requirements and taking appropriate action when necessary

Skills

Regulatory affairs

Pharmacovigilance

Communication skills

Education

Pharmacy degree

Job description

Be Part of Our Growing Pharmaceutical Business

The healthcare and medical industry in Malaysia continues to grow, supported by high-quality products, services and the increasing presence of global healthcare companies.

As a well-established pharmaceutical company, MEDISPEC (M) SDN BHD is looking for a dynamic, ambitious and motivated RA to join our Regulatory Affairs team and contribute to the smooth and effective management of our regulatory operations.

You will play an important role, such as ...

• Ensuring smooth regulatory operations in the RA department
• Managing the lifecycle of pharmaceutical products and medical devices
• Liaising with both external and internal stakeholders as required
• Handling Pharmacovigilance in the company
• Keeping up to date with current regulatory requirements and taking appropriate action when necessary

Who are we looking for?

• A recognized Pharmacy Degree and is registered with the Pharmacy Board of Malaysia.
• A minimum of 5 years of experience in product registration with NPRA and MDA.
• Knowledge of Pharmacovigilance.
• A genuine passion for Product Registration and Regulatory Affairs.
• Strong verbal and written communication skills in English and Bahasa Malaysia.
• A strong team spirit, with the ability to work independently and proactively.
• Malaysian citizenship or relevant residence status.

What are the benefits you are looking at?

• Medical insurance.
• Personal flexible leave.
• Training and certification sponsored by the company.
• Rewards and recognition: Bonus and Long Service Award for performers with achievements.

The Healthcare/Medical industry in Malaysia is well known for its high-quality products and services.

Medispec (M) Sdn Bhd is a leading wholesale distributor and marketer of pharmaceutical and healthcare products in Malaysia with an excellent track record of 40 years. The company’s proven marketing and management systems give a competitive edge to manufacturer’s products.

Currently, it handles a wide range of pharmaceutical and healthcare products from countries all over the whole.

Medispec also assists the manufacturer to register their products with the local Drug Control Authority. Medispec (M) Sdn Bhd is an ISO-9001 and GDPMD certified company.

The Healthcare/Medical industry in Malaysia is well known for its high-quality products and services.

Medispec (M) Sdn Bhd is a leading wholesale distributor and marketer of pharmaceutical and healthcare products in Malaysia with an excellent track record of 40 years. The company’s proven marketing and management systems give a competitive edge to manufacturer’s products.

Currently, it handles a wide range of pharmaceutical and healthcare products from countries all over the whole.

Medispec also assists the manufacturer to register their products with the local Drug Control Authority. Medispec (M) Sdn Bhd is an ISO-9001 and GDPMD certified company.