Senior Regulatory Affairs Pharmacist

Agility HR Solutions Pty; Midrand; On-site; ZAR 300,000 - 400,000; Full time

Job summary

A global pharmaceutical company is looking for a Senior Regulatory Affairs Pharmacist in South Africa. The role includes ensuring compliance with regulations, managing product labelling, and engaging in pharmacovigilance. Candidates should have at least 8 years of experience in regulatory affairs within a pharmaceutical context and a strong understanding of medicine registration processes. The position offers a full-time employment opportunity with a negotiable remuneration package.

Qualifications

• Minimum 8 years of experience as a Regulatory Pharmacist.
• Training in medicine registration and CTD/eCTD processes.
• Proficiency in at least one South African language.
• Excellent written and verbal communication skills.
• Ability to manage multiple tasks effectively.

Responsibilities

• Monitor and ensure compliance with regulatory guidelines.
• Participate in the development of product labelling and packaging materials.
• Collaborate with quality assurance teams to meet regulatory standards.
• Engage in post-marketing surveillance and pharmacovigilance activities.
• Provide strategic recommendations based on regulatory developments.

Skills

Proofreading

Adobe Acrobat

FDA Regulations

Manufacturing & Controls

Biotechnology

Clinical Trials

Research & Development

GLP

cGMP

Product Development

Chemistry

Writing Skills

Education

Pharmacist degree & registration with SAPC

Tools

DocuBridge

Job description

Introduction

A global pharmaceutical company is seeking a Senior Regulatory Affairs Pharmacist with orthodox experience.

Duties & Responsibilities

Regulatory Compliance:

Monitor and ensure compliance with regulatory guidelines and requirements. Stay updated with changes in regulations, assess their impact on the organization's products and processes, and provide guidance to internal stakeholders on compliance matters.

Labelling and Packaging:

Participate in the development and review of product labelling and packaging materials to ensure compliance with regulatory requirements. Ensure that all information is accurate, clear, and aligned with regulatory guidelines.

Quality Assurance Support:

Collaborate with quality assurance teams to ensure manufacturing processes and facilities meet regulatory standards. Participate in audits and inspections to assess compliance and address any non-compliance issues.

Post-Marketing Activities:

Engage in post-marketing surveillance and pharmacovigilance activities. Monitor and report adverse events, evaluate safety data, and ensure appropriate actions are taken to protect patient safety.

Regulatory Intelligence:

Stay informed about the latest regulatory developments, guidelines, and best practices. Analyze the impact of regulatory changes on the organization and provide strategic recommendations. Play a crucial role in supporting product development, registration, and commercialization strategies by assessing regulatory landscapes and advising on potential risks and opportunities. Ensure pharmaceutical products meet regulatory requirements, are safe and effective, and are available to patients in a timely manner.

Desired Experience & Qualifications

• Pharmacist degree & registration with SAPC
• Minimum 8 years of experience as a Regulatory Pharmacist, with exposure to Quality Assurance advantageous
• Currently working at a generic pharmaceutical company specializing in orthodox medicines
• Training in medicine registration and CTD/eCTD processes
• Experience in regulatory dossier compilation, portal navigation, preparation, submission, and maintenance of dossiers and new drug applications
• Proficiency in at least one South African language
• Excellent written and verbal communication skills
• Ability to manage multiple tasks with enthusiasm, prioritization, and attention to detail
• Computer literacy, including experience with DocuBridge and good numeracy skills
• Flexible attitude towards work assignments and a willingness to learn
• Self-motivated, responsible, and proactive in facing challenges

Please contact Lorric Southon for further details.

Package & Remuneration: Negotiable

Required Experience: Senior IC

Key Skills: Proofreading, Adobe Acrobat, FDA Regulations, Manufacturing & Controls, Biotechnology, Clinical Trials, Research & Development, GLP, cGMP, Product Development, Chemistry, Writing Skills

Employment Type: Full-Time

Experience: Years

Vacancy: 1