Principal Regulatory Affairs Specialist

Placements24; Durban; Hybrid; ZAR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Salary commensurate with experience

Health insurance

Retirement savings plan

Performance-based bonuses

Flexible remote working

Job summary

Placements24 is seeking a Principal Regulatory Affairs Specialist to develop and implement regulatory strategies for global pharmaceutical products in a remote role. You will guide product development teams through regulatory requirements for timely approvals with SAHPRA, FDA, and EMA interactions.

You will mentor the regulatory affairs team, manage lifecycle activities, ensure compliant labeling and promotional materials, and contribute to internal SOPs and process improvements.

Qualifications

• Bachelor's or Master's in Pharmacy, Chemistry, Biology, or related field (advantage: higher degree).
• 8+ years in pharmaceutical regulatory affairs with successful submissions.
• Knowledge of SAHPRA, US FDA, and EMA regulatory requirements.

Responsibilities

• Develop and execute regulatory strategies for product registration and lifecycle management.
• Prepare, review, and submit regulatory dossiers (CTD, MAA, NDA) to health authorities.
• Liaise with regulatory agencies and address queries to facilitate approvals.
• Provide regulatory input into development plans, CTD strategies, and manufacturing processes.
• Mentor junior staff and manage post‑approval variations and renewals.

Skills

Regulatory strategy

Dossier submission

Regulatory intelligence

Stakeholder management

Education

Bachelor's or Master's in Pharmacy, Chemistry, Biology or related field

Tools

Regulatory information management systems

Job description

About the Role

Our client, a dynamic and rapidly expanding pharmaceutical company, is seeking an accomplished Principal Regulatory Affairs Specialist to join their esteemed team. This crucial role, based remotely, will focus on developing and implementing regulatory strategies for new and existing pharmaceutical products, ensuring compliance with national and international regulations. You will be instrumental in guiding product development teams through the complex regulatory landscape, facilitating timely approvals and maintaining market authorization. This position offers a unique opportunity to work on a diverse portfolio of innovative therapies from the comfort of your home office. As a Principal Specialist, you will provide expert guidance and mentorship to the regulatory affairs department.

Key Responsibilities

• Develop and execute comprehensive regulatory strategies for product registration and lifecycle management across various global markets.
• Prepare, review, and submit regulatory dossiers (e.g., CTD, MAA, NDA) to health authorities such as SAHPRA, FDA, and EMA.
• Interpret and advise on regulatory requirements, guidelines, and policies affecting product development and marketing.
• Liaise directly with regulatory agencies on behalf of the company, addressing queries and facilitating approvals.
• Conduct regulatory intelligence activities to monitor changes in the regulatory environment and assess their impact.
• Provide regulatory input into product development plans, clinical trial protocols, and manufacturing processes.
• Assess and advise on the regulatory implications of product labeling, advertising, and promotional materials.
• Collaborate with cross‑functional teams (R&D, Clinical, Manufacturing, Marketing) to ensure alignment on regulatory strategies and submissions.
• Mentor and train junior regulatory affairs personnel.
• Manage post‑approval regulatory activities, including variations, renewals, and compliance reporting.
• Contribute to the development and improvement of internal regulatory processes and SOPs.

Requirements

• A Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• A higher degree is advantageous.
• A minimum of 8 years of progressive experience in pharmaceutical regulatory affairs, with a strong track record of successful submissions.
• In‑depth knowledge of regulatory requirements in key markets, including South Africa, the US, and Europe.
• Proven experience in preparing and submitting various types of regulatory dossiers.
• Excellent understanding of drug development processes, GMP, GCP, and GLP.
• Exceptional communication, negotiation, and interpersonal skills.
• Ability to manage multiple complex projects simultaneously in a remote setting.
• Strong analytical and strategic thinking capabilities.
• Proficiency in regulatory information management systems and databases.
• Must have the legal right to work remotely and be based within a reasonable time zone overlap for collaboration with South African operations.

Benefits

• This remote position offers a highly competitive salary, commensurate with experience and qualifications.
• In addition to a generous base salary, benefits include a comprehensive health insurance plan, a retirement savings plan, and potential for performance‑based bonuses.
• Our client values work‑life balance and provides a flexible remote working environment.
• Opportunities for professional development, including specialized training and conference attendance, are readily available.
• This role offers significant potential for career growth and leadership within a progressive pharmaceutical organization.