Regulatory Affairs Manager

3 days ago

Midrand, Gauteng, South Africa Hire Resolve Full time R1 200 000 - R2 400 000 per year
Hire Resolve's client is actively seeking a Regulatory Affairs Manager to join their team in Midrand, Gauteng. As a Regulatory Affairs Manager, you will be responsible for ensuring a thorough and seamless product registration process and dossier maintenance. You will ensure that the company complies with all regulations and maintains pharmacovigilance requirements.

Responsibilities
  • Lead, manage, and execute strategic direction as the regulatory affairs manager.
  • Ensure and supervise that regulatory documentation meets relevant regulatory requirements and specifications.
  • Provide input to the regulatory strategy in line with business objectives.
  • Manage and implement safety updates where required.
  • Manage Chemistry Manufacturing and Controls (CMC / P&A) updates and variations.
  • Handle license renewals with service providers such as SAHPRA and the South African Pharmacy Council (SAPC)
  • Write and develop SOPs in line with Global SOPs.
  • Manage internal and external audits (e.g., Global & SAHPRA)
  • Responsible for updates of dossiers, PI/PIL to ensure compliance with current legislation.
  • Manage product complaints and deviations.
  • Maintain regulatory documentation filing system.
  • Ensure regulatory compliance and quality-related records are available and retained.
  • Coordinate product recall or market withdrawal when necessary.
  • Obtain and distribute updated information on domestic and international laws.
  • Report ADR to Global Safety and SAHPRA and follow up on Adverse Drug Reactions (ADRs).
  • Conduct pharmacovigilance training for local staff14.
  • Answer requests from the Regulatory Authority in cooperation with Global Safety
  • Oversee the implementation and maintenance of QMS to ensure compliance with industry standards and regulations.
  • Identify areas for improvement within the quality system and implement corrective and preventive actions.
  • Provide training to staff on quality standards, regulatory requirements, and best practices.
  • Identify areas for improvement within the quality system and implement corrective measures.
  • Maintain and manage quality related documentation, including standard operating procedures (SOPs), work instructions, and quality records.
  • Ensure compliance with environmental regulations and standards at local, national, and international levels.
  • The manager will also manage releases of finished products, customer complaints etc.
Requirements
  • B. Pharm (Bachelor of Pharmacy).
  • Registration with the South African Pharmacy Council (SAPC).
  • Minimum 10 years' experience in Regulatory Affairs with human medicine and biologicals experience.
  • Product registration and dossier maintenance.
  • Pharmacovigilance experience and knowledge of SAHPRA submission portals.
  • Launch procedures for new products.
  • QA processes, APQRs, customer complaints.
  • Knowledge of Regulations, Acts, and Guidelines for South Africa and East Africa.
  • Microsoft Office Suite proficiency.
  • Familiarity with ZAZIBONA processes and eCTD submissions
  • Systems knowledge.
  • Microsoft office suite including Word, Excel, Power Point at an Intermediate level.
  • Familiar with ZAZIBONA processes.
  • Competent and experienced in eCTD submissions.
Benefits

Contact Hire Resolve for your next career-changing move.

  • Salary: negotiable.

Apply for this role today contact Rebecca Grylls, Ashley Feldtmann, Thomas Stacey, Miné Roux at Hire Resolve or on LinkedIn

You can also visit the Hire Resolve website:  or email us your CV:  [email protected]

We will contact you telephonically in 3 days should you be suitable for this vacancy. If you are not suitable, we will put your CV on file and contact you regarding any future vacancies that arise.

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