Naheem Sadiq
Cmc Regulatory Affairs Associate Director @阿斯利康
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WORK HISTORY
Cmc Regulatory Affairs Associate Director @阿斯利康
Macclesfield, GB
Effectively manage projects or complex product ranges across the portfolio throughout the product lifecycle to deliver the needs of both the AZ business and the customer using project management and tactical delivery expertise. Accountable for interfaces with CMC Product leads, proactively partner with stakeholders across AZ organisation to help deliver and implement innovative risk based regulatory strategies. Project manage global CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards and timelines. Drive the delivery of the regulatory CMC components of business-related projects. Using effective levels of interactive communication with stakeholders and project team members including CMC Regulatory Managers directly advising and influencing those.
EDUCATION
The University of Manchester
Masters, Chemistry with Business Management
SKILLS
ABOUT NAHEEM SADIQ
Chartered chemist and QA professional with a Chemistry and Business Management background. Experience in Quality Assurance in pharmaceutical industry working to cGMP standards. I have knowledge of ICH, Eudralex and FDA guidelines especially concerning licensed product development, stability and CTD submissions. Other skills include R&D (PharmDev, pilot plant), patents (IP), project management (MSProject), laboratory and facility management (HVAC and clean room facilities).
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