Talent.com
Regulatory Affairs Pharmacist
Regulatory Affairs PharmacistBayer • ZA
No longer accepting applications
Regulatory Affairs Pharmacist

Regulatory Affairs Pharmacist

Bayer • ZA
30+ days ago
Job description

Job Purpose:

  • Ensuring that Bayer Consumer Health products are registered and maintained with the relevant regulatory authorities in South Africa and ROSA according to the applicable legislation and guidelines, and in compliance to quality requirements on release of medicine (and other categories; cosmetics, medical devices and food supplement) for sale in line with GMP, Bayer Policies and SOPs, supporting the local business growth by providing guidance to local & enterprise stakeholders and relative functions on the regulatory strategy as well as issues and risks, representing BCH RA as a competent and reliable partner to the relevant competent authorities and stakeholders.

Key Tasks and Responsibilities:

  • Dossier Management: prepare, and submit new product registration dossiers, providing RA assessment on variations and ensure its compliant submission to regulatory bodies in a timely manner.
  • Compliance & Strategy: Ensure products meet local (e.g. SAHPRA, BoMRA, NMRC, MCAZ, ZAMRA etc.) and international regulatory standards; monitor legislative changes and provide strategic advice.
  • Liaison & Communication: Act as the main point of contact with health authorities and collaborate with internal teams (QA, Medical, PV, Marketing, R&D, Supply Chain).
  • Documentation Review: Approve and review packaging, labelling, promotional materials, and internal SOPs for compliance.
  • Lifecycle Management: Manage post-registration activities, including updates, audits, and responding to queries from authorities.
  • Regulatory Intelligence: Keep abreast of new trends, guidance, and regulatory intelligence to inform business decisions

Key working relations:

  • Local, Cluster, Enterprise & Global Regulatory, Medical, and RMSQC/R&D team
  • Country Commercial Lead and respective management team
  • Local Marketing, Medical, PV & Quality
  • External: health authority & trade associations

Required Qualifications:

  • Education: A Bachelor of Pharmacy (B.Pharm)
  • Registration: Must be a registered pharmacist with the South African Pharmacy Council (SAPC).
  • Proven track record in Regulatory Affairs with at least 2 years of experience, including OTC medicines, complementary medicines, medical devices and cosmetics.
  • Experience in quality assurance is an added advantage.
  • Strong understanding of regulatory dossier (CTD/eCTD) requirements for all markets within scope.
  • Excellent scientific writing, communication, and interpretation skills.
  • Ability to work cross-functionally and manage projects.
  • Proactive, detail-oriented, and committed to continuous learning.
  • Fluent in English
Create a job alert for this search

Regulatory Affairs Pharmacist • ZA

Similar jobs

Pharmacist (Gert Sibande)

Right to CareZA

Establish and maintain strategic partnerships with relevant partners within the province.Provide pharmaceutical management support for the district.Ensure that PTCs are conducted according to polic...Show more

 • Promoted

Pharmacist

NetcareZA

The Pharmacist will be responsible for the provision of medication and supplementary services to patients and members of the healthcare team.The incumbent will also assume responsibility for meetin...Show more

 • Promoted

Pharmacist – Alberton City

Clicks GroupZA

The Pharmacist is responsible for providing high standards of pharmaceutical care and dispensary services in accordance with Good Pharmacy Practice as well as certain aspects related to stock and f...Show more

 • Promoted

Pharmacist – Chris Hani Mall – Vosloorus – New Store

Dis-Chem PharmaciesZA

Dis-Chem Pharmacies require the services of a reputable Pharmacist for their Vosloorus store.Your portfolio will cover the provision of pharmaceutical care by taking responsibility for patients’ me...Show more

 • Promoted

Pharmacist Assistant (Post-Basic) Grade 1 to 3 (Institutional)

Western Cape Department of Health and WellnessZA

Grade 1: None after registration as Pharmacist’s Assistant (Post Basic) with the SAPC.Grade 2: A minimum of 5 years’ appropriate experience as Pharmacist Assistant after registration as a Pharmacis...Show more

 • Promoted

Clinical Pharmacist

RPO RecruitmentZA

A reputable private hospital is seeking an experienced Clinical Pharmacist to join their multidisciplinary healthcare team in Kempton Park.Reporting to the Responsible Pharmacist, the successful ca...Show more

 • Promoted

Pharmacist Grade 1

South African Department of Correctional ServicesZA

Basic qualification accredited with the South African Pharmacy Council (SAPC) that allows registration with the SAPC as a Pharmacist.Registration with the SAPC as a Pharmacist.Manage the pharmacy f...Show more

 • Promoted

Pharmacist (Ehlanzeni)

Right to CareZA

Establish and maintain strategic partnerships with relevant partners within the province.Provide pharmaceutical management support for the district.Ensure that PTCs are conducted according to polic...Show more

 • Promoted

Pharmacist – Kriel – Mpumalanga

Dis-Chem PharmaciesZA

Dis-Chem Pharmacies require the services of a reputable Pharmacist for their Kriel store.Your portfolio will cover the provision of pharmaceutical care by taking responsibility for patients’ medici...Show more

 • Promoted

Pharmacy Manager – Clicks Diamond Pavillion

Clicks GroupZA

Are you passionate about helping people feel good? Are you confident to lead a team to deliver high standards of patient care and service excellence? We have an exciting opportunity at a Clicks Pha...Show more

 • Promoted

Pharmacist – Mdantsane (New Store)

Dis-Chem PharmaciesZA

Dis-Chem Pharmacies require the services of a reputable Pharmacist for their Mdantsane store.Your portfolio will cover the provision of pharmaceutical care by taking responsibility for patients’ me...Show more

 • Promoted

Assistant Pharmacist

Max RecruitmentZA

A completed Pharmacy Assistant Qualification as well as registration with the SAPC is essential.At least one year of post-qualification work experience in relevant field.Further two years of post-q...Show more

 • Promoted

Locum Pharmacist Assistant PBQ – Vredenburg

Dis-Chem PharmaciesZA

Dis-Chem Pharmacies require the services of a reputable Post Basic Qualified Pharmacist Assistant for their Vredenburg Area.Your portfolio will cover the provision of pharmaceutical care by taking ...Show more

 • Promoted

Locum Pharmacist – Vredenburg

Dis-Chem PharmaciesZA

Dis-Chem Pharmacies require the services of a reputable Locum Pharmacist for their Vredenburg Area.Your portfolio will cover the provision of pharmaceutical care by taking responsibility for patien...Show more

 • Promoted

Senior Advisor Regulatory Services

Eskom CommunicationsZA

Position: Senior Advisor Regulatory Services Task Grade: G15 Area of specialization: To provide a professional service for regulatory projects and compliance with NERSA related legislation, regulat...Show more

 • Promoted • New!

Pharmacist

Max RecruitmentZA

Bachelor of Pharmacy (BPharm) degree.Further two years of post-qualification work, plus specialization training.Strong working knowledge of English (spoken and written).Working knowledge of Microso...Show more

 • Promoted

Pharmacist – Gauteng, Mpumalanga and Limpopo (Pipeline)

Clicks GroupZA

The Pharmacist is responsible for providing high standards of pharmaceutical care and dispensary services in accordance with Good Pharmacy Practice as well as certain aspects related to stock and f...Show more

 • Promoted

Senior Manager Regulatory Services Markets

SasolZA

To lead and manage economic policy and regulation development and implementation relating to liquid fuel and gas impacting Sasol.Lead the Energy Pricing team in developing and managing prices and t...Show more