MedicalCareers

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Regulatory Affairs Pharmacist – Pharmaceutical

Job Overview

More Information

A Pharmaceutical company has an opportunity for an experienced Regulatory Affairs pharmacist  to join their team.          
Job Title Regulatory Affairs Pharmacist
Name & Title of Direct Superior Head of Regulatory Affairs
Number of Immediate Subordinates/ Direct Reports Zero
Main Purpose of Job
To fulfil the position as regulatory affairs pharmacist for the company and any division within the group.
Key Performance Areas (Core, essential responsibilities –outputs of the position)
·       Responsible for new product applications.

·       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 on-going 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

Minimum Requirements
EDUCATION

Bachelor of Pharmacy Degree

EXPERIENCE

Minimum 2 years’ experience in regulatory affairs in any regulated regions e.g., South Africa Europe, UK, Australia, Canada, Japan

SKILLS/PHYSICAL COMPETENCIES

Docubridge

Sage

Smartsheet

Sweet process

Microsoft:  Excel, Word, PowerPoint, Outlook

 

BEHAVIOURAL QUALITIES

Takes ownership.

Integrity, bound to principles, confidentiality, and ethics.

Strong leadership skills.

Good communication skills.

Good organisational skills.

Good planning skills.

Good follow-up skills

Attention to detail

Assertive.

Conscientious.

Patient.

Co-operative.

Deadline Driven

DESIRABLE SKILLS & EXPERIENCE:

2   Years’ experience in regulatory affairs and attention to detail

Collaboration: Refers to formal and informal relationships.
Responsibility towards:

  • Responsible Pharmacist
  • Procurement
  • Marketing
  • NBD
General working conditions 
  • Office based
Travel
  • SAHPRA
  • Suppliers

Send your updated CV  to Vicki  at vicki@medicalcareers.co.za

Subject : RA Pharmacist

Whatsapp: 067 912 7966

Only candidates can apply for this job.
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