Regulatory Affairs Pharmacist

OttoBauthentic; Johannesburg; On-site; ZAR 300 000 - 400 000; Full time

Job summary

A leading healthcare company in Johannesburg seeks a Regulatory Affairs Specialist to manage medicines registration and ensure compliance with health authorities. The ideal candidate has a B. Pharm Degree and at least 2 years of experience in regulatory affairs. Responsibilities include compiling product applications, liaising with marketing for launches, and managing regulatory documentation. Strong leadership and organizational skills are essential, along with proficiency in various Microsoft applications. This role offers a chance to impact product marketability significantly.

Qualifications

• Minimum 2 years’ experience in regulatory affairs in regulated regions.
• Experience managing product applications and registrations.
• Familiarity with compliance and legislative changes.

Responsibilities

• Responsible for new product applications.
• Ensure compliance of product licenses with health authorities.
• Liaise with marketing for timely product launches.
• Manage regulatory documentation filing system.

Skills

Ownership

Leadership

Communication

Organizational skills

Planning

Attention to detail

Education

B. Pharm Degree

Tools

Docubridge

Sage

Smartsheet

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Microsoft Outlook

Job description

MAIN PURPOSE OF JOB

• Medicines Registration and Maintenance of Product Licenses with various Health Authorities in African countries

RESPONSIBILITIES

• 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.

QUALIFICATIONS & EXPERIENCE

• B. Pharm Degree
• 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