Pharma Regulatory Affairs Specialist: Dossier & Compliance

Placements24; Willows (CA); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

Paid vacation and holidays

Professional development opportunities

Job summary

Placements24 is seeking a diligent Pharmaceutical Regulatory Affairs Associate to support compliance initiatives for a client. Based in Welkom, the role focuses on preparing and submitting regulatory documents, maintaining filings, and staying updated on evolving regulatory landscapes.

The ideal candidate has 1–3 years of experience in regulatory affairs, strong attention to detail, and excellent communication skills to collaborate with R&D, Manufacturing and Marketing teams.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry or related field.
• 1–3 years in pharmaceutical regulatory affairs or similar.
• Familiar with global regulatory submissions (ICH, FDA, EMA).
• Strong understanding of drug development and manufacturing principles.
• Excellent written and verbal communication; detail-oriented.
• Ability to manage multiple tasks and meet deadlines.

Responsibilities

• Assist in preparation, review, and submission of regulatory dossiers (CTD, IND, NDA).
• Maintain regulatory databases and ensure accuracy of product registrations.
• Monitor and interpret changes in regulatory requirements and guidelines.
• Liaise with regulatory agencies to respond to queries and facilitate approvals.
• Review labeling, promotional materials, and advertising for regulatory compliance.
• Collaborate with internal teams (R&D, Manufacturing, Marketing) to meet regulatory requirements.

Skills

Detail-oriented

Analytical skills

Excellent written/verbal communication

Education

Bachelor's degree in Pharmacy/Life Sciences/Chemistry

Job description

Placements24 is seeking a diligent Pharmaceutical Regulatory Affairs Associate to support compliance initiatives for a client. Based in Welkom, the role focuses on preparing and submitting regulatory documents, maintaining filings, and staying updated on evolving regulatory landscapes.

The ideal candidate has 1–3 years of experience in regulatory affairs, strong attention to detail, and excellent communication skills to collaborate with R&D, Manufacturing and Marketing teams.