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Medical - Manufacturing & Distribution Jobs

Regulatory Affairs Pharmacist

Job Information
LocationRecruitment Agency / Vacancy in South Africa, Gauteng
SalaryR600k - R480k
Job TypePermanent
EducationB.Pharm or equivalent
Experience2 - 5 Years
ReferenceRA735-356
Emailpharmacy.jobs(at)hireresolve.co.za
Fax0867502763

Job Description

A great opportunity for an experienced RA Pharmacist has become available within one of the top pharmaceutical companies worldwide!

Requirements:

Must be registered with the South African Pharmacy Council

B.Pharm or relevant pharmacy degree

A minimum of 2 years' regulatory affairs experience

Pharmaceutical, cosmetics and foodstuffs legislation

Working knowledge of pharmacological and pharmaceutical principles

Must be well versified in Registration of medicines (communication with MCC)

Knowledge of Quality Assurance principles, e.g GMP, GWP, etc.

Prior Industry involvement/liaison (SMASA, SAPRAA, etc.)

Responsibilities:

The compilation and registration approval of new product applications in line with Corporate and local time lines to ensure timeous launch of new products.

The maintenance and renewals of current registered products, ensuring compliance with current legislation and requirements, thereby securing continued stock supply.

Monitors, follows up and reports on progress of regulatory submissions.

Managing all activities relating to post-approval dossier maintenance..

Updates current labeling

Conducts document review to ensure the regulatory quality and scientific integrity of documents submitted

Reviews artwork relating to products and ensures it is in line with local requirements.

Must be able to be involved in discussions on regulatory matters

Involved in negotiation of first approval labeling and revisions over product life cycle.

Should you meet the requirements for this position, please email your CV to pharmacy.jobs@hireresolve.co.za or fax to 086 571 7307 or alternatively call Tara/Amy/Madelaine/Zelmari 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 is 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 jobspec@hiresresolve.co.za 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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