Pharmaceutical Regulatory Affairs Specialist

Placements24; Queenstown; Hybrid; NZD 96,000 - 128,000; Full time

Benefits offered by this job

Annual bonus

Medical aid

Retirement benefits

Hybrid work from Queenstown

Professional development support

International markets exposure

Job summary

Placements24 is seeking an experienced Pharmaceutical Regulatory Affairs Specialist to join our client in Queenstown. You will prepare, submit, and manage regulatory dossiers across markets, ensuring compliance with SAHPRA and international guidelines.

The role collaborates with R&D, QA/QC, Medical Affairs and Marketing to support product registrations and lifecycle management. A Bachelor’s degree in a life sciences field and 4–6 years of regulatory affairs experience are required; a Master’s

Qualifications

• Bachelor's degree in a life science field is required.
• Master's degree preferred; SAHPRA knowledge advantageous.
• 4–6 years in pharmaceutical regulatory affairs.
• Experience compiling/submitting regulatory dossiers (CTD/eCTD).
• Knowledge of SAHPRA and other markets is a plus.

Responsibilities

• Prepare and submit regulatory dossiers (CTD/eCTD) for new drug applications, variations, and renewals.
• Liaise with regulatory authorities to facilitate the review and approval process.
• Monitor and interpret changing regulatory landscapes and advise the company accordingly.
• Review and approve product labeling, promotional materials, and marketing claims for regulatory compliance.
• Manage post-approval regulatory commitments and ensure ongoing compliance.
• Respond to queries from regulatory agencies in a timely and accurate manner.
• Maintain regulatory databases and ensure accurate record-keeping of submissions/approvals.
• Collaborate with R&D, QA/QC, Medical Affairs, Marketing on regulatory strategies.
• Conduct regulatory intelligence to stay informed about new guidelines.
• Support the development of regulatory strategies for new product launches and market expansions.

Skills

Regulatory affairs experience

CTD/eCTD knowledge

Regulatory intelligence

Excellent communication

Education

Bachelor's degree in Pharmacy, Chemistry, Biology

Tools

Regulatory information management systems

Job description

About the Role

Our client, a growing pharmaceutical company with a strong focus on emerging markets, is seeking an experienced Pharmaceutical Regulatory Affairs Specialist to join their team. This role is primarily based at our offices in Queenstown, Eastern Cape , with a hybrid work arrangement offering flexibility. You will be responsible for preparing, submitting, and managing regulatory documentation required for the approval and maintenance of pharmaceutical products in various markets. This includes compiling dossiers, responding to regulatory agency inquiries, and ensuring compliance with national and international regulations. The ideal candidate will possess a thorough understanding of regulatory affairs principles, excellent attention to detail, and strong communication skills. You will work closely with R&D, quality assurance, and marketing departments to ensure seamless product registration and lifecycle management. This is a critical role for ensuring market access and compliance for our client's innovative therapies. The hybrid model allows for focused regulatory work and essential team collaboration in Queenstown .

Key Responsibilities

• Prepare and submit regulatory dossiers (e.g., CTD/eCTD) for new drug applications, variations, and renewals.
• Liaise with regulatory authorities to facilitate the review and approval process.
• Monitor and interpret changing regulatory landscapes and advise the company accordingly.
• Review and approve product labeling, promotional materials, and marketing claims for regulatory compliance.
• Manage post-approval regulatory commitments and ensure ongoing compliance.
• Respond to queries from regulatory agencies in a timely and accurate manner.
• Maintain regulatory databases and ensure accurate record-keeping of all regulatory submissions and approvals.
• Collaborate with internal departments (R&D, QA/QC, Medical Affairs, Marketing) on regulatory strategies.
• Conduct regulatory intelligence activities to stay informed about new guidelines and requirements.
• Support the development of regulatory strategies for new product launches and market expansions.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field.
• A Master's degree or equivalent experience is preferred.
• Minimum of 4-6 years of experience in pharmaceutical regulatory affairs, with a strong understanding of global regulatory requirements.
• Proven experience in compiling and submitting regulatory dossiers.
• Familiarity with Common Technical Document (CTD) format.
• Knowledge of South African regulatory requirements (SAHPRA) is essential; experience with other emerging markets is a plus.
• Excellent written and verbal communication skills, with strong attention to detail.
• Strong analytical and problem-solving skills.
• Ability to manage multiple projects and prioritize tasks effectively.
• Proficiency in regulatory information management systems is advantageous.
• Must be comfortable working in a hybrid environment from Queenstown, Eastern Cape .

Benefits

• Competitive annual salary of ZAR .
• Annual bonus based on company and individual performance.
• Comprehensive medical aid and retirement benefits.
• Generous annual leave and professional development support.
• Opportunities to work on diverse pharmaceutical products and international markets.
• Hybrid work arrangement from our Queenstown, Eastern Cape office.

Be a key contributor to bringing vital medicines to patients.