Hikma Pharmaceuticals
Job Specific Accountabilities
- Manages regulatory plans for the submission of new products and maintenance activities for existing products to meet regulatory plans.
- Coordinates all regulatory activates for submissions throughout the regulatory life cycle to ensure proper execution of submissions.
- Reviews submission documentation including correspondences, dossier content and labelling materials to ensure that submissions are of high quality that complies with standards and regulations.
- Maintains awareness of applicable regulations and guidance to keep project teams informed about the new information, along with its possible impact to the projects, as appropriate.
- Participates in communications with health agencies and regulatory authorities to discuss relevant issues and ensure smooth submissions and approvals processes.
- Reviews and provides regulatory input on various types of agreements to make sure they comply with regulatory standards.
- Develops regulatory due diligence reports to evaluate potential products opportunities received from licensors from a regulatory point of view and make appropriate recommendations to colleagues in Business Development department accordingly.
- Identifies potential regulatory risks as part of due diligence activities and propose mitigation plans and alternative regulatory scenarios to support the introduction of new product opportunities from licensors.
- Leads communications with licensors in order to carry out due diligence activities effectively.
Required Criteria:
- Years of Experience: 10 to 15 Years over all, minimum 7 years in managerial role.
- Qualifications: Bachelor’s degree in pharmacy is a must, master’s in pharmacy, or Business is a plus.
- Area of work: Responsible of Iraq- Base Baghdad
Apply
To help us track our recruitment effort, please indicate in your cover/motivation letter where (vacanciesiniraq.com) you saw this job posting.