Regulatory Affairs Senior Executive/Executive

Hovid; Selangor; On-site; MYR 200,000 - 250,000; Full time

Job summary

A leading pharmaceutical company is seeking a RA Senior Executive/Executive (OEM Registration) to manage the registration process for various products. The ideal candidate will possess a scientific degree and relevant industry experience, and be responsible for regulatory compliance and communication with health authorities.

Qualifications

• Minimum of 2-5 years of experience in regulatory affairs, preferably in the pharmaceutical industry.
• Good written and communication skills in both English and Bahasa Melayu.
• Understanding of regulatory requirements and proven experience in submission processes.

Responsibilities

• Prepare and submit registration dossiers for generics, biosimilars, new drug product and injectable products.
• Communicate with Malaysia health authorities and address queries.
• Manage product lifecycle, including renewals and variations.

Skills

Regulatory compliance

Communication skills

Organizational skills

Attention to detail

Education

Scientific degree in Pharmacy, Life Sciences, Chemistry

Job description

Regulatory Affairs Senior Executive/Executive

Add expected salary to your profile for insights

We are a renown pharmaceutical company currently on the lookout for a new RA Senior Executive/Executive (OEM Registration) to join our growing team.

Job Responsibilities:

Prepare and submit registration dossiers for generics, biosimilars, new drug product and injectable products.

Have experiences in handling registration of imported products.

Maintain and update regulatory documentation.

Ensure compliance with local and international regulatory requirements.

Communicate with Malaysia health authorities and address queries.

Manage product lifecycle, including renewals and variations.

Collaborate with internal teams and manufacturers for regulatory compliance.

Prepare regulatory reports and updates for management.

Job Requirements:

Possess a scientific degree in Pharmacy, Life Sciences, Chemistry, or a related field.

Minimum of 2-5 years of experience in regulatory affairs, preferably in the pharmaceutical industry.

Working experience with the NPRA Malaysia will be considered an added advantage.

Candidate must possess a solid understanding of regulatory requirements and proven experience in submission processes, especially for generic drugs, biosimilars, new drug products, and injectables.

Good written and communications skills in both English and Bahasa Melayu.

Excellent organization, ability to work independently and manage multiple projects.

Discipline, detail oriented and able to work independently or part of a team.

Note: Only candidates who have been shortlisted will be contacted.

Unlock job insights

Salary match Number of applicants Skills match

Your application will include the following questions:

How many years' experience do you have as a Regulatory Affairs Executive? 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 would you rate your English language skills? How much notice are you required to give your current employer?

Pharmaceuticals, Biotechnology & Medical 51-100 employees

Hovid (formerly known as Ho Yan Hor) carries with her years of invaluable experience in the pharmaceutical industry.

Dating back to early 1940s, when the business was first established, Hovid's only commodity was Ho Yan Hor Herbal Tea, concocted by its founder, Dr Ho Kai Cheong. With the intention of helping people, Dr Ho Kai Cheong formulated a unique concoction of 24 specially chosen herbs and developed Ho Yan Hor Herbal Tea. It was a popular alternative to western medicine during post World War II with its Cooling and Anti Viral properties. Ho Yan Hor Herbal Tea was the most seek after solution during the Worldwide Flu Epidemic in 1950s. Since then, Ho Yan Hor has become a household name. After 74 years, Ho Yan Hor Herbal Tea still remains as the favorite among many as a natural herbal beverage.

In the 1980s, along with his father's success, David Ho, as a well trained pharmacist, led Hovid into a new chapter of manufacturing excellence. Armed with expertise in pharmacy with strong passion of entrepreneurship, David ventured into mainstream medical approaches. From that point on, Hovid grew to become one of the Malaysia's leading pharmaceutical manufacturers of high quality and innovative medicinal preparations and health supplements with more than 400 products distributed over 50 countries globally.

Listed on the Main Board of Kuala Lumpur Stock Exchange, Hovid spells familiarity and quality among healthcare providers. With the various divisions in the organization that have been established through years of experience, we are able to deliver speed, excellence and above all, Continuous Innovation and Quality.

Hovid (formerly known as Ho Yan Hor) carries with her years of invaluable experience in the pharmaceutical industry.

Dating back to early 1940s, when the business was first established, Hovid's only commodity was Ho Yan Hor Herbal Tea, concocted by its founder, Dr Ho Kai Cheong. With the intention of helping people, Dr Ho Kai Cheong formulated a unique concoction of 24 specially chosen herbs and developed Ho Yan Hor Herbal Tea. It was a popular alternative to western medicine during post World War II with its Cooling and Anti Viral properties. Ho Yan Hor Herbal Tea was the most seek after solution during the Worldwide Flu Epidemic in 1950s. Since then, Ho Yan Hor has become a household name. After 74 years, Ho Yan Hor Herbal Tea still remains as the favorite among many as a natural herbal beverage.

In the 1980s, along with his father's success, David Ho, as a well trained pharmacist, led Hovid into a new chapter of manufacturing excellence. Armed with expertise in pharmacy with strong passion of entrepreneurship, David ventured into mainstream medical approaches. From that point on, Hovid grew to become one of the Malaysia's leading pharmaceutical manufacturers of high quality and innovative medicinal preparations and health supplements with more than 400 products distributed over 50 countries globally.

Listed on the Main Board of Kuala Lumpur Stock Exchange, Hovid spells familiarity and quality among healthcare providers. With the various divisions in the organization that have been established through years of experience, we are able to deliver speed, excellence and above all, Continuous Innovation and Quality.

To help fast track investigation, please include here any other relevant details that prompted you to report this job ad as fraudulent / misleading / discriminatory.

What can I earn as a Regulatory Affairs Executive