What are the responsibilities and job description for the Regulatory Affairs Specialist position at Katalyst CRO?
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.
- 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).
