اعلان توظيف صادرعن الحكمة للأدوية
تعلن شركة حكمة للادوية عن حاجتها الى موظفين بتخصصات علمية
Title: Specialist, Regulatory Affairs
PURPOSE: To conduct R&D activities in order to develop new products, procedures and technologies while also conducting research activities that continually improve upon existing products.
KEY ACCOUNTABILITIES: Description Policies, Processes & Procedures
Recommends improvements to departmental policy and directs the implementation of procedures and controls covering all areas of Research and Development department activity so that all relevant procedural/legislative requirements are fulfilled while delivering a quality, cost- effective service to customers. Day- to-day operations
Supervises the day-to-day operations of the Research and Development department/section to ensure that work processes are implemented as designed and comply with established policies, processes and procedures. Job Specific Accountabilities
Coordinates all regulatory activities for submissions throughout the regulatory life cycle from preparation, submission, deficiency letters to approvals and variations to ensure efficiency in execution for each step Implements regulatory plans for the submission of new products and maintenance activities for existing products to meet department plans
Requests, gathers and performs a technical critical evaluation of the essential documentation to identify what is needed for the submissions
Informs the site about the regulatory actions to perform follow ups until approval of dossier, deficiency letter or supplement/variations
Prepares, coordinates and follows up the renewal processes/annual report to comply with the department objectives and ensure deadlines are fulfilled 2 Confidential
Monitors the life cycle of approved dossier to ensure it is kept up to date
Updates all internal control tables and maintains visibility of the documents including all submissions and approvals to align with internal SOPs
Provides regulatory advice to assist teams and give updates at staff meetings Maintains awareness of applicable regulations and guidance to keep up to date with the relevant guidelines and information that could impact the regulatory projects.
Coordinates and follows-up with cross functional departments to ensure that submission documents are available in time to meet submission timelines and to ensure that documents meet the authority guidelines and standards
Trains and guides newly hired resources on all relevant regulatory guidelines and procedures to ensure they are well equipped to perform their tasks efficiently Continuous Improvement
Contributes to the identification of opportunities for continuous improvement of systems, processes and practices taking into account ‘international best practice’, improvement of business processes, cost reduction and productivity improvement. Reporting Prepares departmental reports of the Research and Development department timely and accurately to meet company and department requirements, policies and standards. Safety, Quality & Environment Complies with all relevant safety, quality and environmental management policies, procedures and controls to ensure a healthy and safe work environment. Related Assignments
Performs other related duties or assignments as directed
QUALIFICATIONS, EXPERIENCE, & SKILLS: Minimum Qualifications: Bachelor’s degree in physical sciences (Chemistry, Pharmacy, Chemical Engineering) with preferably a masters. Minimum Experience: 3 to 5 years’ experience in the pharmaceutical industry or relevant experience with at least 1 year in the regulatory affairs field.
Amman, Bayader Wadi Al-Seer, JO, 11118
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