Regulatory Affairs Manager

APEX Pharma New Cairo, Cairo

105
Applicants for
1 open position
29
Viewed
2
In Consideration
52
Not Selected
Experience Needed:
10 to 15 years
Career Level:
Manager
Job Type:
Full Time
Salary:
Confidential
Vacancies:
1 open position
About the Job
  • Set submission strategy & Leading functionally the regulatory affairs departments in the region.
  • Lead the preparation of regulatory documents/files required for new registration and Re-registration product maintenance (line extensions, variations, license renewals) and responses to Health Authority queries.
  • Ensure that all the above RA documents/files are complied with the most recent regulations and being provided to distributor and or Health authority in challenging time frame to meet local RA plans/objectives.
  • Keep up-to-date knowledge on regulatory legislation and requirements.
  • Develop, write and update, as appropriate, RA document that encompasses all regulatory requirements/ legislations in countries to act as guidance and road map for management.
  • With shared accountability and cross-functional teamwork together provide expert opinion to management in regards to new product development, portfolio management, and product approval.
  •  Support local and global Commercial, Business Development, Supply chain and Regulatory Affairs departments with registration and launch strategies for upcoming and ongoing products registrations.
  • Following up with different NODCAR departments, Registration and inspection.
  • Keeping an excellent relation with MOH stakeholder in Egypt.
  • Managing any product complaint with Health authority.
Job Requirements
  • Bachelor degree of Pharmaceutical science.
  • 10 + years of experience in RA management.
  • Communication & Negotiation skills.
  • Leadership & Management skills.
  • Problem Solving & decision -making skills. 
  • Analytical Thinking.
  • Result- oriented.
About this Company

APEX Pharma ultra-modern state of the art manufacturing facility was built on 14,000 m2 of a total area of 57,551 m2 and is located in Badr City, Cairo.Multi-Apex Pharma was granted the approval by the Egyptian Ministry of Health-to manufacture Pharmaceutical dosage forms in... (More)

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