Regulatory Affairs Pharmacist

Our well-established client in the pharmaceutical industry has a vacancy available for a Regulatory Affairs Pharmacist to be based at the Parktown office. 

Main Purpose of Job
To fulfil the position of regulatory affairs pharmacist within 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 the marketing department to facilitate the timely launch of products.
• Approval of master batch documentation prior to product production.
• Responsible for SOP implementation/review, update and compliance.
• Managing and maintaining the 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

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 (e.g., shift work, driver’s license, specific tools, special clothing, environmental requirements, etc.)

• Office-based/For International remote

Travel
• SAHPRA
• Suppliers

Please attach cv, qualifications, id and drivers license