
Regulatory Documentation Specialist
1 week ago
Our pharmaceutical organisation is seeking a Regulatory Documentation Specialist to provide support in preparing regulatory documentation for our global product portfolio.
Key responsibilities include:
- Creating templates for study and regulatory documentation for CMC dossier, R&D reports
- Generating technical reports for regulatory submissions and preparing regulatory CMC sections
- Preparing regulatory CMC sections including developmental to commercial phases of products lifecycle
- Drafting SOP, policy and work instruction documents for R&D department
- Monitoring regulatory developments and advising management on the potential impact of regulations on the organisation
Requirements:
- Bachelor degree or post graduate degree in Life Sciences
- Sound industry experience in pharmaceutical, medical device, biotech
- Minimum 3 years regulatory experience in the pharmaceutical industry
- Virology background highly desirable
- Strong scientific technical writing skills
- Demonstrated ability to work across sites and across international teams
- Excellent interpersonal and communication skills
- Strong relationship building skills and the ability to influence key stakeholders
This is an excellent opportunity to join our team as a Regulatory Documentation Specialist.
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