Global Regulatory Affairs Specialist — Dossier & Submissions Expert

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

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.