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Job Description
- 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.
Job Requirements
- Bachelor’s degree in pharmacy, science.
- Min 7 years’ previous experience in pharmaceutical industry. .
- Experience of Drafting Regulatory Files
- Excellent English, verbal / written communication.
- Strong communication skills & networking.
- Ability to work well through others.
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