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وصف الوظيفة:

Title: Specialist, Regulatory Affairs

Description:

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.

JOB DIMENSIONS:

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.

Location:

Amman, Bayader Wadi Al-Seer, JO, 11118

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