Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
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.
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.