Job Description

Job Description

Job Description

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.
• 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.

• 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.

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