Regulatory Affairs Pharmacist

Description

Job Title : Regulatory Affairs Pharmacist
Location : 0012
Company : Careers Unlocked
Salary :
Open Date : 2021-04-08
Close Date : 2021-06-08

Our client in the Pharmaceutical industry is looking for a Regulatory Affairs Pharmacist to manage all aspects of product Life-Cycle management within the Regulatory Affairs function. The role reports directly into the Head of Regulatory Affairs and it is based in Johannesburg.


Minimum requirements:

• Bachelor of Pharmacy degree is essential

• Must be registered with the South African Pharmacy Council (SAPC)

• Minimum of 2 - 4 years Regulatory Affairs experience in pharmaceutical industry.

• Experience working with SAHPRA and other Regulatory Authorities in Africa.

• Proficient in both verbal and written English language.

• eCTD submission experience is essential.

• Ability to multitask and manage multiple projects simultaneously.

• Must have strong communication skills.

• Experience in liaising with stakeholders, including but not limited to Business Managers, Quality Assurance & Marketing departments

• Knowledge of relevant legislation, regulations and guidelines pertaining to the Pharmaceutical

Industry.

• In-depth knowledge of regulatory requirements.

• Understanding of regulatory compliance and the impact this can have on the business.

• Good Understanding of Quality Management Systems, SAHPRA Guidelines and Policies,

Medicines and Related substances and regulations, GMP and any other QA/RA related

guidelines.


Key responsibilities:

• Compile and submit new product applications and ensure that the registration requirements are

fulfilled so that the registration process and approval can be obtained as soon as possible.

• Monitor and follow up on the progress of submissions.

• Activities relating to product lifecycle management.

• Maintain and develop working relationships effectively and provide required regulatory support.

• Reviewing artwork relating to products ensuring that it is in compliance with all legal requirements.

• Checking Format and Content Compliance with latest codes of conduct and regulations.

• Keeping abreast of developments and changes in the local regulatory environment which directly impacts on the product brands.

Should you be interested in this opportunity, kindly forward your updated resume to [email protected]


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