Regulatory Affairs Pharmacist - Parktown, South Africa - The Perfect Placements

The Perfect Placements

Verified Company

Parktown, South Africa

3 weeks ago

Posted by:

Thabo Mthembu

beBee Recruiter

Description

Our client, a leading company in the pharmaceuticals industry is looking for qualified, career-driven, motivated, passionate, results-driven, team player, analytical and resilient Regulatory Affairs Pharmacist.

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This position will be based at their head office in Parktown, Gauteng_

Key Performance Areas:

Compilation and submission of Post Registration amendments to ensure dossier

- compliance.

Responsible for pre and post registration SAHPRA Committee recommendation responses to ensure product registration.
Responsible for dossier updates, PI/PIL updates to ensure compliance with current legislation
To ensure approval and compliance of printed packaging material and promotional marketing material.
Liaising with marketing department to facilitate timeous launch of products.
Approval of master batch documentation prior to product production.
Responsible for SOP implementation/review, update and compliance.
Managing and maintaining regulatory documentation filing system.
Ensuring regulatory compliance and quality related records are available and retained.
Ensure ongoing regulatory compliance of the existing product portfolio.
Ensure awareness of legislative changes and trends that will impact the core function of the regulatory affairs department and hence the marketability of company products
Liaise with business development for regulatory requirements prior to dossier acquisition.
Training and peer review of documents

Skills and Competencies:

Docubridge
Sage
Smartsheet
Sweet process
Microsoft: Excel, Word, PowerPoint, Outlook
Takes ownership and is assertive
Integrity, bound to principles, confidentiality, and ethics.
Strong leadership skills.
Good communication and organisational skills.
Good planning and follow up skills.
Attention to detail
Conscientious.
Patient and Cooperative.
Deadline Driven

Education and Experience:

Bachelor of Pharmacy Degree
2 Years' experience in regulatory affairs
Minimum 2 years' experience in regulatory affairs in any regulated regions e.g., South Africa, Europe, UK, Australia, Canada, Japan

Travel:

SAHPRA
Suppliers

Salary:

R R80 000pm based on experience

If you think you are the perfect fit, please submit a head and shoulders picture along with your updated CV

Salary:

R60, R80,000.00 per month

Ability to commute/relocate: