Industry: Dubai
Job Description:
One of our clients a Pharmaceutical Company with operations in US, Europe & Japan is hiring “Manager – Regulatory Affairs” for Dubai with prior experience with the US market preferably.
Responsibilities
• Provide technical support their own & 3rd party products
• Review and comment on any and all documents related to IND/ANDA filings Suggest the regulatory pathway at review meetings providing regulatory strategy for its own & third party products at meetings
• Manage regulatory strategy for ANDAs as well as manage annual reports and responses to FDA review
• Handle responsibilities related to review, submission, and maintenance of eCTD ANDAs & IND’s
• Be Responsible for the supervision of day-to-day activities for (RA) Associates and provide training as & when required
Knowledge and Skills
• 7 – 10 years of regulatory affairs experience within generic pharmaceutical space
• M.Pharm / M.Sc / Pharm D or PhD in a scientific discipline
• Must be self-motivated and a team player working in a dynamic regulatory environment
• Microsoft Word, Adobe Acrobat, Microsoft Office Suite and eCTD
• Relevant experience working with solid/oral and liquid dosage
• Submission experience along with regulatory affairs 3rd party strategy
• Experience of managing team is preferred
About us, ACE Vega is a 360 degree recruitment and complete HR Solutions provider, focusing operations in Africa, Europe, India and Middle East.
Interested applicants are requested to send their resume and below mandatory details at the earliest . Should you have any reference for this requirement kindly share with us.
• Recent Resume:
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Send your CVs to [javascript protected email address]