Regulatory Affairs Associate
|Location||Recruitment Agency / Vacancy in Port Elizabeth|
|Salary||R750k - R450k|
|Education||B.Pharm or B.Sc. essential|
|Experience||2 - 5 Years|
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 firstname.lastname@example.org 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 email@example.com 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