Job Vacancy: Export Regulatory Affairs Specialist
Company Profile: – Future Pharmaceutical Industries (FPi) is a national pharmaceutical company that offers a real and reliable partnership to the healthcare community, by fulfilling its emerging needs for both patients and healthcare providers.
– Job Overview:
Submitting all the documents required for registration & renewal process of the company at different M.O.H.’s for all the countries worldwide.
Preparing CTD & e-CTD registration & renewal files of pharmaceutical, cosmetics and food supplement products as to be registered in International countries worldwide (CIS Region, African Countries, Gulf Region, Asian Countries, South America Countries & European countries) according to the guidelines of each country.
Preparing Technical Registration, Renewal and Tenders files of products (Pharmaceutical, Food Supplement & Over the Counter Products) and submitting any other documents requested by different M.O.H.’s.
Study and follow updated guidelines issued periodically concerning global preparation of registration and renewal files and maintain current knowledge of relevant regulations, including proposed final rules.
Check up the specifications & method of analysis of finished products and raw materials in updated editions of different pharmacopeia.
Oversee documentation efforts to make sure compliance with local as well as international regulations standards.
Coordinate with different departments of Research, Production, Planning, financial and other sectors to follow up the execution of all the requirements of different countries in addition to solving their related problems.
Review of analytical validation, manufacturing validation, pharmaceutical development and stability study reports to ensure compliance with license details and relevant guidelines and directives.
Specifying storage, labeling and packaging requirements, liaising closely with the regulatory authorities on a regular basis.
Responding to agents requests as Prices quotation and coordinating between them and the financial and export sectors.
Ensure the arrival of the couriers and follow up with their corresponding agents to provide the files to their concerned ministry.
Implement or monitor complaint processing systems to make sure effective timely resolution of all complaint investigations.
Investigate product complaints as well as prepare documentation submissions to appropriate regulatory agencies as necessary.
Manage activities like audits, regulatory agency inspections, or product recalls.
Participate in the development or implementation of clinical trial protocols by gathering information from updated versions of scientific references.
Provide responses to regulatory agencies regarding product information or issues.
Review all regulatory agency submission materials to make sure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
– Education:
· Bachelor degree of Pharmaceutical Science or Vet.
– Related Experience
· 1-2 years of experience in Export DRA.
· CTD and /Or e-CTD practical experience is a must
– Skills
· Negotiation & communication skills
· Organization skills and high accuracy in documentation
· High sense of urgency
· Priority setting and management
· Knowledge of new decrees & guidelines
· Promptness in respond to authorities requirements and prompt in deliverables
· Analytical skills
· Strong team spirit
Interested candidates are kindly requested to send their updated CVs with a recent photo to [email protected] & Mention the job code: ERA in the subject line.
