Remote Senior Regulatory Affairs Specialist – Pharma

Placements24; Willows (CA); Remote; USD 54,000 - 78,000; Full time

Benefits offered by this job

Home office stipend

IT support for remote work

Health insurance

Job summary

Placements24 seeks a Senior Regulatory Affairs Specialist to join a dynamic pharmaceutical manufacturer in a remote capacity. The role focuses on ensuring compliance with SAHPRA and international guidelines, preparing regulatory dossiers, and guiding cross-functional teams on regulatory strategies.

The ideal candidate has 6+ years in regulatory affairs, strong analytical skills, and the ability to work independently under tight deadlines from a remote setting. Master’s degree is a plus.

Qualifications

• 6+ years of progressive experience in pharmaceutical regulatory affairs.
• Thorough knowledge of SAHPRA and ICH guidelines.
• Experience preparing and submitting registration dossiers for various product types.

Responsibilities

• Prepare, review, and submit regulatory dossiers (CTD format) for new product registrations and variations.
• Liaise with regulatory agencies, respond to queries and address deficiencies promptly.
• Monitor regulatory changes and assess impact on products and operations.
• Develop regulatory strategies to support product development and lifecycle management.
• Review labeling, packaging, and promotional materials for compliance.
• Provide regulatory guidance to R&D, marketing, and manufacturing teams.
• Maintain regulatory databases and ensure accurate record-keeping.
• Manage post-approval activities including renewals and change controls.

Skills

Regulatory affairs

Dossier submission

SAHPRA knowledge

Remote work capable

Education

Bachelor's degree in Pharmacy, Chemistry, Biology

Master's degree or equivalent

Tools

RIM systems

MS Office

Job description

Placements24 seeks a Senior Regulatory Affairs Specialist to join a dynamic pharmaceutical manufacturer in a remote capacity. The role focuses on ensuring compliance with SAHPRA and international guidelines, preparing regulatory dossiers, and guiding cross-functional teams on regulatory strategies.

The ideal candidate has 6+ years in regulatory affairs, strong analytical skills, and the ability to work independently under tight deadlines from a remote setting. Master’s degree is a plus.