Regulatory Affairs Specialist (Sr/ Manager, Healthcare, Medical, Pharma) #HDC

Regulatory Affairs Specialist (Sr/ Manager, Healthcare, Medical, Pharma) #HDC

Main Job Responsibilities

• Provide medical review and assure compliance of promotional materials in accordance with approved labeling, applicable regulations and industry standards.
• Plans and prepares complex regulatory documents for global registrations.
• Ensures effective coordination and implementation of regulatory activities in support of new product approval/registration and maintenance in all markets.
• Critically reviews complex reports, validations, etc. for scientific merit and regulatory appropriateness.
• Maintains professional relationships with functional areas outside regulatory.
• Acts as company liaison with HSA and other Regulatory Agencies.
• Monitor and ensure appropriate ongoing Company-wide regulatory compliance with applicable GMP/ISO/EN standards and other pertinent standards.
• Reviews proposed labeling and promotional material to ensure that the intended use and claims are supported for use and domestic and international regulations are met.
• Provides strategic direction and advice to project team regarding regulatory pathways and timelines for new and changed products/processes.
• Establishes, organizes and maintains regulatory records.
• Obtains and manages foreign registrations; partner with appropriate representatives to locally confirm and file foreign regulatory requirements.
• Ensures compliance with global regulations and regulatory agencies.
• Maintains familiarity with current medical literature and surgical techniques in the field.
• Supports the development and implementation of regulatory strategies throughout the product life cycle including product development , labeling, promotional materials and regulatory evaluation of changes
• Performs additional duties as assigned.

EDUCATION AND EXPERIENCE

• Min Degree in any science related field
• Minimum 6 years of experience in either domestic and regional regulatory affairs would have an advantage
• Min of 2-3 years experience as a RA Manager would be preferred
• Familiar with regulatory affairs such as NDA, variation and renewal of product registrations in Pharmaceutical industry (manufacturer or distributor) would be at an advantage
• Pharmacovigilance (or safety monitoring/reporting) experiences preferred but not mandatory

If you are interested in the position, do kindly drop your most updated resume to recruithealth@recruitexpress.com.sg (Attn: Regulatory Affairs Manager)

Thank You.