Regulatory Affairs Section Head

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Obour City, CairoPosted 3 years ago

50Applicants for1 open position

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Responsible for All Pharmaceutical products
Recommends, develops, and implements regulatory strategies and policies to maintain and maximize opportunities for current and proposed core category products.
Updates licensing and collects information on registration instructions and regulations.
Manages the final product submissions and negotiates and communicates effectively with regulatory authorities to obtain timely product approvals & pricing.
Provides direct assistance with the registration of new and existing products in markets supplied by the plant.
Assumes regulatory review of labeling content, product and process changes and product documentation.
Provides the product development project teams with regulatory input in order to obtain timely regulatory approvals for the products as part of the product development planning.
Contributes to the development and management of product development project time lines to ensure timely product registrations based on company strategic plans.
Manages the distribution of new regulations, standards, policies, and guidelines issued by relevant regulatory authorities that may impact the company.
Provides input for preparation of the department’s budget; ensures that the department operates within capital and expense budget guidelines.
Submits and follows up new registration, Re-registration, variation files for analysis till receiving conformity
Follows up batches and raw material samples submitted for analysis till receiving conformity.