Seasoned hands-on regulatory affairs professional, 20+ years registrations and compliance experience, coupled with a quality control, quality assurance and clinical research experience, implementing regulatory strategies for drugs. Proven success in providing regulatory input for product lifecycle planning and determining submission and approval requirements. Ability to plan and manage new drug application in India and Pakistan, registration of generic products in EU, South Africa, India, Pakistan and Bhutan, site registrations, network changes, manufacturing license and other complex submissions. Experience as a direct correspondent to negotiate, interface, and build relationships with ...
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