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Regulatory Affairs Officer
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Hidd, Bahrain GULF BIOTECH BSC CLOSED Full timeMain Responsibilities: - Ensure adherence to local and international regulatory guidelines. - Handle CTD and eCTD submissions for product registrations. - Supervise product registration procedures and engage with regulatory bodies. - Proficiency in utilizing eCTD publishing software for submissions. - Develop regulatory strategies in coordination with...
Regulatory Affairs In-charge
1 month ago
Key Job Requirements:
Have relevant qualification and 5-7 years of experience in pharmaceutical industry
Prepare and file regulatory submissions (CTD & eCTD expertise required)
Perform assessments of new or revised products
Manage complaint documentation (including investigation and closure) & recalls
Have sound knowledge of pharmacovigilance
Respond to inquiries from regulatory bodies
Should have excellent communication and organizational skills
Up-to-date knowledge of International and local guidelines
Regulatory certifications will be preferred
**Experience**:
- pharmaceutical industry: 5 years (preferred)