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Medical - Laboratory Jobs

Regulatory Affairs Associate

Job Information
LocationRecruitment Agency / Vacancy in South Africa, Gauteng
SalaryR750k - R450k
Job TypePermanent
EducationB.Pharm or B.Sc. essential
Experience2 - 5 Years

Job Description

A global biopharmaceutical production company is seeking to employ a Regulatory Affairs Associate.


B.Pharm or B.Sc. essential

2 – 5 Years Regulatory experience in the pharmaceutical manufacturing industry

Knowledge of MCC guidelines and policies

Must be independent

Strong interpersonal skills

Strong analysis and reporting abilities


Manage the life-cycle of the company product brand registrations in accordance with MCC requirements and company SOP’s

Maintaining regulatory compliance for all product brands, line extensions, material source changes etc,

Ensuring correctness of amendments printed packaging components

Providing regulatory advice on all brands

Supporting the QA, NPT, Procurement and Production departments

Communicating with all levels within the company

Keeping abreast of developments and changes within local regulatory environment

Managing product information databases

Checking and authorising the Bill of Materials, Terms of Supply, Registered Technical Details etc.

Evaluating and determining the relevance of and processing technical changes with the MCC

Present product brand support documents in a manner to ensure MCC approvals

Managing all regulatory aspects of product brands

Reporting on all authorisation data

Should you meet the requirements for this position, please email your CV to or fax to 086 571 7307 or alternatively call on 021 551 8638.

Correspondence will only be conducted with short listed candidates. Should you not hear from us within 3 days, please consider your application unsuccessful.

Hire Resolve offers a R1000 for any candidate that I referred and placed through Hire Resolve. Hire Resolve also offers a R1000 job spec fee for any referral that results in a placement through Hire Resolve. If your company is looking for any IT, Finance and Engineering staff, please email us at with the company name, a contact person and contact email or number of the person doing the hiring. We will keep the referral strictly confidential.

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