Senior Regulatory Affairs Lead — Strategy & Submissions

Roche; Subang Jaya; On-site; MYR 120,000 - 150,000; Full time

Job summary

A global pharmaceutical company is seeking a Senior Regulatory Affairs professional in Subang Jaya, Malaysia. In this role, you will set strategies for regulatory affairs, oversee submission processes, and ensure compliance with local and global standards. The ideal candidate has over 5 years of experience in regulatory affairs, a pharmacy degree, and fluency in English and Bahasa Malaysia. This position offers the opportunity to lead a team and influence regulatory policies for enhanced patient access.

Qualifications

• Minimum 5 years in a regulatory affairs role within a pharmaceutical environment.
• Trained in GMP and GDP requirements for pharmaceuticals.
• Knowledgeable in Malaysian pharmaceutical regulations and registration.

Responsibilities

• Develop and implement innovative regulatory strategies for affiliate products.
• Lead strategic oversight of regulatory filing activities.
• Build partnerships with local Healthcare Authorities.

Skills

Regulatory Affairs experience

Fluent in English and Bahasa Malaysia

Good Manufacturing Practice (GMP) knowledge

Good Distribution Practice (GDP) knowledge

Leadership skills

Education

Degree in Pharmacy

Job description

A global pharmaceutical company is seeking a Senior Regulatory Affairs professional in Subang Jaya, Malaysia. In this role, you will set strategies for regulatory affairs, oversee submission processes, and ensure compliance with local and global standards. The ideal candidate has over 5 years of experience in regulatory affairs, a pharmacy degree, and fluency in English and Bahasa Malaysia. This position offers the opportunity to lead a team and influence regulatory policies for enhanced patient access.