Senior Regulatory Affairs Specialist - Pharmaceutical Submissions

Placements24; Durban; Hybrid; ZAR 1,000,000 - 1,400,000; Full time

Benefits offered by this job

Health insurance

Performance bonuses

Remote-first environment

Paid time off

Retirement savings plan

Job summary

Placements24 is seeking a Senior Regulatory Affairs Specialist for a fully remote role, supporting global regulatory submissions from South Africa. The ideal candidate will lead preparation of dossiers (NDAs, MAAs) and manage lifecycle activities across FDA, EMA, SAHPRA and other agencies.

Strong ICH knowledge and experience with eCTD are essential. The role requires 6+ years in regulatory affairs, a life sciences degree, and a track record of working independently in a remote setting.

Qualifications

• Extensive regulatory affairs experience with drug submissions (NDA/MAA/IND) and lifecycle management.
• Solid knowledge of ICH guidelines and global regulatory requirements.
• Experience with electronic submission formats and gateways (eCTD) is essential.

Responsibilities

• Prepare and submit high-quality regulatory dossiers to major health authorities.
• Develop regulatory strategies for product registration and lifecycle management.
• Monitor regulatory changes and advise on potential impact to dossiers and labeling.
• Collaborate with R&D, Manufacturing and Marketing to ensure compliance.
• Provide regulatory guidance and training to internal teams.

Skills

Regulatory strategy

Dossier submission

Global regulatory knowledge

Independent work

Education

Bachelor's or Master's in Pharmacy/ Chemistry/ Biology

PhD is a plus

Tools

eCTD

Job description

About the Role

Our client, a distinguished pharmaceutical company, is seeking a highly experienced Senior Regulatory Affairs Specialist to join their team on a permanent, fully remote basis. This critical role will focus on preparing, submitting, and managing regulatory dossiers for new drug applications and post-approval changes across various global markets. You will be instrumental in ensuring compliance with diverse international regulatory requirements and providing strategic guidance on regulatory pathways. This is an outstanding opportunity to leverage your expertise in a remote-first environment, contributing directly to bringing essential medicines to patients worldwide from your home base, supporting operations relevant to Durban, KwaZulu-Natal .

Key Responsibilities

• Prepare and compile high-quality regulatory submission documents (e.g., CTD modules, INDs, NDAs, MAAs) for Health Authorities globally.
• Liaise with Health Authorities to address queries and provide necessary information throughout the review process.
• Develop and implement regulatory strategies for product registration and lifecycle management.
• Monitor and interpret evolving regulatory landscapes, guidelines, and legislation relevant to pharmaceutical products.
• Conduct regulatory assessments of product labeling, advertising, and promotional materials.
• Collaborate with internal departments (e.g., R&D, Manufacturing, Marketing) to ensure regulatory requirements are met.
• Manage post-approval regulatory activities, including variations, renewals, and annual reports.
• Contribute to the development and maintenance of company regulatory procedures and policies.
• Provide regulatory guidance and training to other functional areas as needed.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life sciences field. A Ph.D. is a plus.
• A minimum of 6 years of progressive experience in pharmaceutical regulatory affairs.
• Demonstrated experience in preparing and submitting major regulatory dossiers (e.g., NDAs, MAAs) to key regulatory agencies (e.g., FDA, EMA, SAHPRA).
• In-depth knowledge of ICH guidelines and regional regulatory requirements.
• Experience with electronic submission formats and gateways (e.g., eCTD).
• Strong understanding of drug development processes, manufacturing, and quality control.
• Excellent analytical, strategic thinking, and problem-solving abilities.
• Exceptional written and verbal communication skills, with a meticulous attention to detail.
• Proven ability to work independently and manage multiple complex projects in a remote setting.

Benefits

• This fully remote role offers a competitive salary, comprehensive health, dental, and vision insurance, performance bonuses, generous paid time off, and a retirement savings plan.
• We support continuous professional development through training and conference attendance.
• As a remote-first employee, you will benefit from unparalleled flexibility and autonomy while making a significant impact on global health initiatives, supporting our strategic reach to areas like Durban, KwaZulu-Natal .