Job Description

Regulatory Affairs Pharmacist Regulatory
Pretoria-GautengOur client, a pharmaceutical manufacturing company, urgently requires a dedicated and detail-oriented Regulatory Affairs Pharmacist to join their team. This role is essential for ensuring full compliance with regulatory requirements in South Africa and other designated markets. The ideal candidate will be proficient in managing regulatory submissions, writing and reviewing Chemistry Manufacturing and Controls (CMC) documentation, and maintaining a comprehensive understanding of regulatory guidelines.Key Responsibilities:Regulatory Submissions

• Prepare, compile, and submit regulatory dossiers for new product registrations, renewals, and variations to SAHPRA and other relevant authorities.
• Manage timelines for regulatory submissions and approvals to ensure compliance with project schedules.

CMC Writing

• Write and review high-quality CMC documentation for regulatory submissions, including Module 3 of the Common Technical Document (CTD).
• Ensure CMC documents are accurate, complete, and compliant with local and international regulatory requirements.

Regulatory Compliance

• Monitor and interpret regulatory requirements and guidelines, including changes to legislation and industry standards.
• Provide regulatory advice to cross-functional teams to ensure compliance throughout the product lifecycle.

Liaison and Communication

• Act as the primary contact with regulatory authorities, responding to queries and providing additional information as required.
• Collaborate with internal departments, including R&D, quality assurance, and manufacturing, to gather necessary information for regulatory submissions.

Documentation and Records Management

• Maintain regulatory documentation and records, ensuring they are up-to-date and readily accessible.
• Implement and manage electronic document management systems (EDMS) for regulatory submissions and compliance tracking.

Training and Development

• Provide training and guidance to junior regulatory affairs staff and other stakeholders on regulatory requirements and best practices.
• Participate in professional development opportunities to stay current with regulatory trends and updates.

Qualifications and Experience:

• Bachelors degree in Pharmacy or a related field.
• Minimum of 3-5 years of experience in regulatory affairs within the pharmaceutical industry.
• Demonstrated experience in CMC writing and preparation of regulatory submissions.
• Experience with SAHPRA submissions and familiarity with South African regulatory requirements.
• Experience in Docubridge or a similar electronic submission management system will be an advantage.
• Proficiency in electronic document management systems (EDMS) and regulatory submission software.

We are looking for individuals with outstanding analytical and problem-solving abilities, the capacity to work independently and as part of a team, a strong sense of integrity and professionalism, and robust interpersonal skills. If you possess these qualities and can work effectively with diverse teams, seize the opportunity to join our client's team and make a significant contribution to the compliance and success of a dynamic pharmaceutical company. Apply now!Apply for this Job

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