Regulatory Affairs Specialist
Regulatory Affairs Specialist
Posted on :
15-04-2025
Employer Active
1 Vacancy
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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 worklife balance needs.
- Coordinate and prepare documents/packages for regulatory submissions ensuring accuracy and compliance.
- Review edit and proofread regulatory documentation to maintain highquality 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.
- Bachelors 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.
Employment Type
Full Time
Key Skills
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