Remote Pharma Regulatory Affairs Specialist

Placements24; Willows (CA); Hybrid; USD 90,000 - 140,000; Full time

Benefits offered by this job

Competitive salary with incentives

Health, dental, and vision benefits

Paid time off

Job summary

Placements24 is seeking a meticulous Regulatory Affairs Specialist to support our client from a fully remote position. The role focuses on ensuring pharmaceutical products meet global regulatory requirements and involves preparing and submitting documentation, liaising with health authorities, and staying current with evolving regulations.

You will work with R&D, QA, and Marketing to provide regulatory guidance, maintain documentation and databases, and manage multiple projects independently in

Qualifications

• Bachelor's degree in a scientific discipline is required.
• Proven experience in Pharmaceutical Regulatory Affairs.
• Demonstrated experience in preparing and submitting regulatory dossiers.
• Strong understanding of global regulatory requirements (FDA/EMA).
• Excellent written and verbal communication skills.
• Ability to work independently and manage multiple projects remotely.

Responsibilities

• Prepare, review, and submit regulatory submissions to health authorities globally (INDs, NDAs, MAAs).
• Ensure compliance with regulatory requirements, guidelines, and company policies.
• Liaise with regulatory agencies during submissions and reviews.
• Monitor new regulations and assess impact on products and operations.
• Maintain regulatory documentation and databases for accuracy and completeness.
• Collaborate with R&D, QA, and Marketing to provide regulatory guidance.

Skills

Regulatory submissions

FDA/EMA knowledge

Attention to detail

Remote work

Cross-functional collaboration

Education

Bachelor's degree in Pharmacy/Chemistry/Biology

Tools

Regulatory databases

Job description

Placements24 is seeking a meticulous Regulatory Affairs Specialist to support our client from a fully remote position. The role focuses on ensuring pharmaceutical products meet global regulatory requirements and involves preparing and submitting documentation, liaising with health authorities, and staying current with evolving regulations.

You will work with R&D, QA, and Marketing to provide regulatory guidance, maintain documentation and databases, and manage multiple projects independently in