Regulatory Affairs Pharmacists
|Location||Recruitment Agency / Vacancy in Durban|
|Salary||R400k - R350K|
Primary Duties Include:
• Will need to 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.
• Will need to Monitor and follow up on the progress of submissions.
• Activities relating to dossier maintenance.
• 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.
• Evaluate, submit and check relevant typed stability test rapports for approval.
• B.Pharm/B.Sc Degree or scientific equivalent.
• A minimum of 3-5 years’ experience in Regulatory Affairs.
• Practical Experience in Regulatory environment preferable.
Technical Skills and Competencies:
• Knowledge of Acts. Regulations and guidelines pertaining to the Pharmaceutical Industry.
• In-depth knowledge of regulatory requirements.
• Strong writing skills and computer Literacy.
• Understanding of regulatory compliance and the impact this can have on the business.
• Quality Management Systems.
• MCC Guidelines and Policies.
• Medicines and Related substances and regulations.
• MCC guide to GMP
Should you meet the requirements for this position, please email your CV to email@example.com 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 firstname.lastname@example.org 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.
or email us: pharmacy.jobs(at)hireresolve.co.za