Vacancies At BioGeneric Pharma
BioGeneric Pharma S.A.E., a leading factory in biotechnology in the Middle East, is seeking to hire ” Regulatory Affairs Associate Manager ” The ideal candidate will have a strong background in Regulatory Affairs and a proven track record of success in the pharmaceutical industry, with the following requirements:
Responsibilities:
· Technical review of all regulatory documents before submission.
· Preparation of complete regulatory files for submission to regulatory authorities.
· Ensure timely submissions of regulatory documents to meet regulatory requirements and BGP’s timelines for registration.
· Establish strong communication with all stakeholders involved in the registration process to ensure smooth implementation and approval process.
· Respond to requests from the EDA during the evaluation process in a timely manner to prevent any delays.
· Be updated on all registration guidelines, specifically guidelines for registration of biological product and Vaccines.
Requirements:
· Pharmacy bachelor’s degree
· 4-5 years of experience in regulatory affairs and working with the EDA
· In-depth knowledge of current relevant guidelines and legislations in Egypt for regulatory procedures.
· Biologicals registration experience is a must.
· Pricing experience is a plus.
· Pharmacovigilance certification is a plus.
Interested and qualified candidates are encouraged to send their updated CVs to: ezzat.keriakos@biogenericpharma.com
===============================================================
BioGeneric Pharma S.A.E., a leading factory in biotechnology in the Middle East, is seeking to hire ” Qualification & Validation Section Head ” The ideal candidate will have a strong background in human resources management and a proven track record of success in the pharmaceutical industry, with the following requirements:
Responsibilities:
· Enforce the implementation of cGMP and system requirements at BioGeneric pharma S.A.E according to relevant regulations, guidelines, procedures and SOPs.
· Plan and follow up execution of production area qualification, equipment, utilities and supplier qualification by staff. Revise their relevant protocols and reports.
· Plan and follow up execution of process validation and cleaning validation by staff. Revise their relevant protocols and reports.
· Plan and follow up execution of calibration of BGP equipment by staff either internally or externally by approved outsourced agents. Revise their relevant reports and certificates.
· Follow up analytical validation performance by QC department.
Requirements:
· Bachelor degree in Pharmaceutical Sciences.
· At least 7 years experience in the qualification and validation field of a pharmaceutial company
· Preferable have Six sigma Green or Black Belt.
· Leadership and team building skills.
· Ability of planning, prioritizing and project management
· Effective communication with various levels
· Decision maker
· Ability to measure performance and effectiveness of different processes
· Able to manage changes
Interested and qualified candidates are encouraged to send their updated CVs to: ezzat.keriakos@biogenericpharma.com
Quoting the job title “Qualification & Validation Section Head “in the subject field.