Regulatory Affairs Pharmacist at Human Accent

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