Job vacancy Regulatory Affairs Manager - Pharma

• 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.

The Successful Applicant

• 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.

What's on Offer

• 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.

ContactGeralynne GohQuote job refJN-032024-6375450Phone number6012 284 3402

MYR13,000 - MYR15,000 per month (MYR156,000 - MYR180,000 per year) (MYR)

26 Jun, 2024 (53 days left)