Regulatory Affairs Manager - Pharma (Start Up)

Michael Page

Kuala Lumpur
RM 156,000-180,000 per year
Permanent
Full-time

1 month ago
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Are you passionate about Regulatory Affairs and driven to make an impact in the pharmaceutical industry? This RA Manager will work closely with the CEO and key stakeholders in Southeast Asia to ensure successful regulatory objectives. Your expertise will be crucial in overseeing regulatory projects.

Leading Regulatory Strategy: Develop and implement regulatory strategies for product development and registration, ensuring compliance with local and international regulations.
Develop and implement effective regulatory strategies for new product introductions and modifications, ensuring alignment with business objectives.
Oversee the life cycle of the existing product portfolio, ensuring regulatory compliance and timely license renewals.
Project Management: Oversee regulatory projects from initiation to completion, including planning, execution, and monitoring of regulatory submissions and approvals.
Cross-functional Collaboration: Collaborate with internal teams to ensure alignment of regulatory activities with overall project goals and timelines.
Regulatory Compliance: Ensure adherence to regulatory requirements throughout the product lifecycle, including post-market surveillance and compliance activities.
Stakeholder Communication: Serve as the primary point of contact for regulatory agencies, external partners, and key stakeholders, providing updates on project progress and addressing regulatory inquiries and challenges.

Start-up environment with vast experience and exposure |Regional exposure in Southeast Asia

Study background: Bachelor's degree or professional qualification, preferably with a major in Life Science, Pharmacy, Biotechnology or a related technical field.
An established candidate with a minimum of 5 year's experience in the Pharmaceutical.
Experience in Regulatory Affairs with strong track records, product registrations and life cycle management. Quality assurance and Pharmacovigilance experience would be an advantage.
Outstanding strategic planning with the ability to develop actionable solutions and recommend strategies.
Exceptional effective interpersonal relationship & communication skills with both internal and external stakeholders
Have fluent oral and written communication skills in English. Mandarin would be a great advantage.

Our client is a start-up pharmaceutical company that was incorporated recently and prides itself on innovation for innovative drugs and medical diagnostics around the globe and commercializing it to Southeast Asia and Middle East markets. This company is committed to increasing the quality standard that would be trusted to improve people's health. The company offers ample opportunities for career advancement, continuous learning, and skill enhancement through training programs, mentorship, and exposure to diverse projects.

Opportunity to advance your career in a regional setting.
Opportunity to build rapport and closely work with various internal and external stakeholders in the healthcare industry.
Work-from-home flexibility.
Be part of an entrepreneurial culture that fosters solution creativity and problem-solving, offering a stimulating and rewarding work environment.

Michael Page