Regulatory Affairs Specialist - Dossier Preparation

Placements24; Queenstown (MD); On-site; USD 42,000 - 60,000; Full time

Benefits offered by this job

Competitive salary package

Health, dental, and vision insurance

Annual performance bonus opportunities

Generous paid time off and holidays

Retirement savings plan with employer

Professional development

Collaborative work environment

Career advancement opportunities

Job summary

Placements24 client, a pharmaceutical company, seeks a Regulatory Affairs Specialist to manage regulatory dossiers for health authority submissions and ensure timely approvals. You will compile submission packages, maintain regulatory compliance, and liaise with stakeholders.

You will collaborate with R&D, QA, and manufacturing, maintain databases, respond to health authority queries, and support audits and lifecycle management. Strong CTD knowledge and global regulatory experience are essential.

Qualifications

• Bachelor's in Pharmacy, Life Sciences, Chemistry or related field; Master’s advantageous.
• Minimum 3 years in regulatory affairs with dossier preparation experience.
• CTD format knowledge and regional regulatory requirements (SAHPRA, FDA, EMA).
• Excellent written and verbal communication with attention to detail.
• Ability to manage multiple submissions and work with global teams.

Responsibilities

• Compile, review, and assemble regulatory dossiers for MAAs/NDAs/variations per CTD and regional rules.
• Liaise with R&D, clinical ops, QA, and manufacturing to gather information and ensure dossier accuracy.
• Ensure all submissions comply with regulatory guidelines; maintain databases and track lifecycle.
• Prepare responses to health authority queries during the review process.
• Conduct regulatory intelligence to stay updated on changing landscapes.
• Support post-approval variations and lifecycle management; assist audits and inspections.
• Collaborate with global regulatory teams to harmonize submission strategy.
• Review product labeling and promotional materials for compliance.

Skills

Regulatory affairs

Dossier preparation

CTD familiarity

Regulatory intelligence

Documentation management

Project management

Communication skills

Education

Bachelor's degree in Pharmacy/Life Sciences/Chemistry

Master's degree advantageous

Tools

RIMS software

Document management systems

Job description

About the Role Our client, a dynamic pharmaceutical company focused on bringing innovative medicines to market, is actively recruiting a dedicated Regulatory Affairs Specialist to manage and prepare regulatory dossiers for submission to health authorities. This role is crucial for ensuring timely approval of new drug applications and variations. You will be responsible for compiling comprehensive submission packages, maintaining regulatory compliance, and liaising with internal and external stakeholders. The position is based at our offices in Queenstown, Eastern Cape, within a collaborative and growth-oriented environment. We are committed to navigating complex regulatory landscapes to deliver life-saving treatments to patients worldwide. This role requires meticulous attention to detail and a thorough understanding of global regulatory requirements.

Key Responsibilities

• Compile, review, and assemble regulatory dossiers for various submission types (e.g., MAAs, NDAs, variations) in accordance with regional requirements (e.g., CTD format).
• Liaise with R&D, clinical operations, quality assurance, and manufacturing departments to gather necessary information and ensure dossier accuracy and completeness.
• Ensure that all submitted documentation complies with current regulatory guidelines and standards.
• Maintain regulatory databases and track submission status, approvals, and lifecycle management activities.
• Prepare responses to queries from health authorities during the review process.
• Conduct literature searches and regulatory intelligence activities to stay informed about changing regulatory landscapes.
• Assist in the preparation of post-approval variations and lifecycle management submissions.
• Support regulatory audits and inspections.
• Collaborate with global regulatory teams to ensure harmonized submission strategies.
• Review product labeling and promotional materials for regulatory compliance.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field. A Master's degree is advantageous.
• Minimum of 3 years of direct experience in regulatory affairs within the pharmaceutical industry, with a focus on dossier preparation and submission.
• Proven experience in compiling and managing regulatory submission documents.
• Thorough understanding of the Common Technical Document (CTD) format and regional regulatory requirements (e.g., SAHPRA, FDA, EMA).
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to interpret scientific and regulatory information effectively.
• Proficiency in using regulatory information management systems (RIMS) and document management systems.
• Strong organizational and project management skills, with the ability to manage multiple submissions concurrently.
• Ability to work independently and collaboratively in a team environment.
• Proactive approach to problem-solving and regulatory challenges.

Benefits

• Competitive salary package based on experience.
• Comprehensive health, dental, and vision insurance.
• Annual performance bonus opportunities.
• Generous paid time off and company holidays.
• Retirement savings plan with employer contribution.
• Professional development and training opportunities.
• Supportive and collaborative work environment.
• Opportunities for career advancement within a growing organization.