Regulatory Affairs Pharmacist

Number of Vacancies: 1

Location: The role is office based in Aeroton south of Johannesburg.

Absolute prerequisite: Bachelor’s degree in Pharmacy and registered with the South African Pharmacy Council.

CV submission Requirements:

• Comprehensive and current CV.
• Notice period.
• Current and expected CTC.

Join Our Team as a Regulatory Pharmacist!

We’re hiring a Regulatory Pharmacist to join a top South African pharmaceutical manufacturer. This critical role ensures the approval and registration of life-saving medicines with key authorities. Take on this pivotal responsibility and help shape the future of healthcare. Apply now!

About the Company:

Our Client is a leading South African pharmaceutical manufacturer listed on the Johannesburg Stock Exchange. They manufacture, market, and distribute a wide range of healthcare products and is a leading supplier to both the private and public sectors of the market.

About the Role:

Responsibilities

Support the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners and Principals, and to control and manage portfolio outputs. To ensure legal compliance with the relevant medicine Regulatory Authorities (Country Specific where applicable), Medicines and Related Substances Control Act and South African Pharmacy Council, ensuring timeous processing of regulatory applications.

• Ensure timeous initiation and management of the registration process for new product submissions.
• Ensure approval of registration applications of all medicines with the relevant authorities.
• Completes specific pre-registration activities including receipt, screening, compilation and timeous submission of dossier/s Regulatory Authority.
• Ensures that all assigned dossiers are submitted timeously to relevant health authorities and are followed up on regularly in order to enable registrations.
• Ensures that required standards, protocols and processes around obtaining dossiers and gathering supporting data from suppliers are followed after signing of appropriate agreements.
• Ensure the maintenance/ update of registrations in accordance with the relevant legislation, regulations and guidelines.
• Receives, prepares and submits all applicable updates, variations, resolutions and any other correspondence required by the Regulatory Authority.
• Completes dossier audits of Registered Products for the assigned products.
• Conducts dossier due-diligences, post-registration variations for all applicable Regulatory Authorities in compliance with the latest regulatory guidelines and applicable Regulations within the specified time-lines in order to support the business and strategic company.

Objectives 

• Establish and maintain effective relationships with Regulatory Authorities.
• Manages relationships with the Regulatory Authorities to ensure more effective streamlining of the company’s applications when required.
• Building sustainable relationships with internal and external stakeholders to achieve regulatory goals.
• Effectively managing, auditing and implementation of Regulatory systems.
• Prepare, review and adhere to Standard Operating Procedures (SOP’s) and local Regulatory Guidelines.
• Ensure alignment of personal and company values.

Qualifications and Skills:

• Bachelor’s degree in Pharmacy and registered with the South African Pharmacy Council.
• 1-2 years’ experience in Regulatory Affairs, preferably in orthodox, human medicines.
• Demonstrable experience across the product development, commercialization, and life-cycle maintenance. 
• Sound project management capabilities.
• Proven ability to consistently deliver to quality, time and cost standards.
• Knowledge of new and emerging Acts, Regulations and Guidelines pertaining to the pharmaceutical industry. 
• Experience in use of CTD software builder and compilation of eCTD applications will be an advantage such as docuBridge. 

About the Candidate:

• Attention to detail.
• Knowledge of the Regulatory requirements for medical products in South Africa and other applicable territories. 
• Project management skills.
• Leadership skills.
• Ability to prioritize and work to tight deadlines.
• Systems approach.
• Cross Functional skills: Ability to network, liaise and negotiate with others.
• Ability to set standards and objectives and monitor progress.
• Problem solving and decision-making skills.
• Sound project management capabilities.

Please note that if you have not been contacted within 4 weeks then, unfortunately, the application has not been successful. We wish you all the best in your search!

APPLY HERE

Referrals are most welcome and are well rewarded, find out more about our referral program.