Regulatory Affairs Officer Ftc

2 weeks ago

Cape Town, Western Cape, South Africa Biovac Full time

BIOVAC is one of the leading sterile vaccine manufacturers rooted in Africa, with our core purpose being to "protect life".


We are looking to hire a dynamic, passionate, confident, proactive, and meticulous Regulatory Affairs Officer FTC to join a goal-oriented team.


QUALIFICATIONS NEEDED:

  • Diploma / BSc Degree.
  • SAPC registered as a Post Basic Pharmacist Assistant.

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

  • At least 13 years of regulatory experience in eCTD (Extedo) / esubmission compilation of registration dossiers within the pharmaceutical/ biotech manufacturing industry.
  • At least 13 years of experience in regulatory administration of electronic management systems with a high degree of computer literacy (MS Office).
  • Experience in quality and regulatory compliance within a cGMP facility.

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

  • Assist the regulatory affairs pharmacists in compiling and maintaining the life cycle of the Company existing product registrations according to prescribed SOPs.
  • Assist the regulatory affairs pharmacist with the compilation of new product dossier compilations according to prescribed SOPs.
  • When required to assist with all packaging artwork processes/amendments of printed packaging components to ensure the accurate compilation, proofreading, and maintenance of artwork files according to prescribed SOPs.
  • To assist and proactively manage advertising electronic/hard copy filing systems and/or product information material by effectively communicating with and ensuring delivery to all relevant stakeholders.
  • To help the RA team by coordinating and actively managing various adhoc projects to meet the required deadlines and specifications.
  • To assist with preparation for internal and external Audits of RA.
  • Provide Regulatory Support to Project Team as assigned.
  • Maintenance of Regulatory Affairs department archives to ensure that all related regulatory documentation, and vaccine product information are maintained and up to date in line with the audit readiness state.
  • Digitalization of Archived documents.
  • Maintenance of electronic folders (SAHPRA guidelines and other related documentation).
  • Assist with maintenance and tracking of regulatory activities.
  • Printing and binding of any submission as required by the regulatory affairs pharmacists.
  • Filing of any correspondence/ submissions / electronic submission support
  • Arranging for SAHPRA deliveries as and when required
  • Data capturing and maintaining relevant databases.
  • Ensuring that the department is audit ready by closing out audit findings timeously.
  • Ensure Deviations, Change Controls, and CAPAs are handled effectively.
  • By submitting your CV and personal information, you agree that Biovac may utilise this information to conduct and complete our recruitment process, which entails distributing your information to all internal recruitment participants and service providers who forms part of the process._

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