Regulatory Affairs Pharmacist

2 weeks ago

Johannesburg, South Africa MedicalCareers Full time

A Pharmaceutical company has an opportunity for an experienced Regulatory Affairs pharmacist to join their team.

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)
- 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

**Job Type**: Permanent

**Salary**: R60,000.00 - R80,000.00 per month

Ability to commute/relocate:

- Johannesburg, Gauteng: Reliably commute or planning to relocate before starting work (required)

**Education**:

- Bachelors (required)

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