Regulatory Affairs Specialist

Responsibilities: 

• We are seeking a dedicated Regulatory Affairs Specialist to manage and coordinate our regulatory submission processes. 
• This role offers the flexibility of being fully remote or hybrid, catering to your work-life balance needs. 
• work hours: 8am to 4pm. 
• Coordinate and prepare documents/packages for regulatory submissions, ensuring accuracy and compliance. 
• Review, edit, and proofread regulatory documentation to maintain high-quality standards. 
• Assist in the preparation and review of labeling, Standard Operating Procedures (SOPs), and other departmental documents. 
• Compile regulatory documents for submission under supervision. 
• Participate actively as a team member in project teams as required. 
• Prepare and compile responses to regulatory authorities' questions. 
• Maintain regulatory files in formats consistent with requirements. 
• Stay updated on regulatory requirements and maintain awareness of changes. 
• Manage a specific product portfolio within the region, ensuring all regulatory aspects are addressed. 

Requirements: 

• Bachelor's degree or equivalent in pharmacy or a related scientific discipline. 
• Minimum 2 years of regulatory experience, preferably within a healthcare environment. 
• Solid scientific knowledge with the ability to interpret technical data. 
• Excellent written and verbal communication skills. 
• Proficiency in technical systems, including word processing, spreadsheets, databases, and online research. 
• Meticulous proofreading and editing abilities. 
• Capability to contribute to multiple projects from a regulatory affairs perspective. 
• Solid multitasking and prioritization skills to manage various tasks effectively. 
• Minimum 2 years of experience. 
• Education: Bachelors (required).