Regulatory Affairs Executive

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

Job summary

A leading Malaysian pharmaceutical company is seeking a Regulatory Affairs Executive to ensure compliance with regulations for its diverse product portfolio in Selangor. Responsibilities include monitoring regulations, preparing submissions, and collaborating with teams. Candidates should have a relevant degree and at least 3 years of experience in regulatory affairs. Competitive salary, benefits, and growth opportunities are offered in a collaborative work environment.

Benefits

Competitive salary and performance-based bonuses

Comprehensive medical and insurance benefits

Opportunities for professional development

Collaborative work environment

Qualifications

• Minimum 3 years of experience in regulatory affairs in the pharmaceutical or medical device industry.
• Thorough understanding of Malaysian pharmaceutical and medical device regulations.
• Ability to work independently and as part of a team.

Responsibilities

• Monitor and interpret changes in regulatory requirements.
• Prepare and submit regulatory applications.
• Liaise with regulatory authorities for timely submissions.
• Maintain comprehensive regulatory documentation.
• Support new product development with regulatory expertise.
• Collaborate to address regulatory challenges.
• Stay updated with industry trends.

Skills

Communication skills

Analytical skills

Problem-solving abilities

Regulatory knowledge

Teamwork

Education

Degree in Pharmacy, Pharmaceutical Sciences

Tools

MS Office

Job description

As a Regulatory Affairs Executive at Biocare Pharmaceutical, you will play a crucial role in ensuring the company's pharmaceutical and medical device products comply with all relevant regulations and guidelines. Based in Petaling Jaya, Selangor, this full-time position will involve managing the regulatory processes for Biocare's diverse product portfolio.

What you'll be doing

• Monitoring and interpreting changes in regulatory requirements, guidelines and industry best practices
• Preparing and submitting regulatory applications, such as product registrations, renewals and variations
• Liaising with regulatory authorities and internal teams to ensure timely and compliant submissions
• Maintaining comprehensive regulatory documentation and records
• Supporting the development of new products by providing regulatory expertise and guidance
• Collaborating with cross-functional teams to address regulatory challenges and find solutions
• Staying up-to-date with industry trends and developments to identify opportunities for process improvements

What we're looking for

• Degree in Pharmacy, Pharmaceutical Sciences, or a related field
• Minimum 3 years of experience in regulatory affairs within the pharmaceutical or medical device industry
• Thorough understanding of pharmaceutical and medical device regulations, especially in Malaysia
• Excellent communication and stakeholder management skills
• Strong analytical and problem-solving abilities
• Ability to work independently and as part of a team
• Proficient in MS Office applications

What we offer

• Competitive salary and performance-based bonuses
• Comprehensive medical and insurance benefits
• Opportunities for professional development and career advancement
• Collaborative and supportive work environment

About us

Biocare Pharmaceutical is a leading Malaysian pharmaceutical and medical device company that has been providing innovative healthcare solutions for over 20 years. Driven by our mission to improve the quality of life for our customers, we are committed to the highest standards of quality, safety, and regulatory compliance. Join our dynamic team and be a part of our continued growth and success.

Apply now to become our next Regulatory Affairs Executive!