Remote Regulatory Affairs Specialist — Fast, Global Submissions

Kamel Media; Philippines; Remote; PHP 1,877,934 - 2,934,272; Full time

Benefits offered by this job

Cost savings

Flexible working hours

Expertise in international regulations

Job summary

A leading BPO company is looking for a dedicated Regulatory Affairs Specialist based in the Philippines. This role involves managing regulatory submissions for FDA and CE marking, ensuring compliance with healthcare regulations. The ideal candidate should have a background in pharmaceutical sciences and experience with regulatory tools like eCTD. By outsourcing this expertise, companies can significantly reduce costs while ensuring compliance and accelerating time to market. This position offers a unique opportunity to work closely with teams internationally and contribute to regulatory success.

Qualifications

• Experience in regulatory submission preparation and management.
• Familiarity with international regulations and compliance standards.
• Proficient in regulatory documentation and strategy.

Responsibilities

• Draft and review regulatory submissions for various products.
• Coordinate with cross-functional teams to align on regulatory requirements.
• Maintain regulatory intelligence and update strategies accordingly.

Skills

FDA regulations

CE marking

Health Canada regulations

Regulatory strategy development

Post-market surveillance

Education

Background in pharmaceutical sciences, biotechnology, or regulatory science

Tools

eCTD

Cortellis

Citeline

Job description

A leading BPO company is looking for a dedicated Regulatory Affairs Specialist based in the Philippines. This role involves managing regulatory submissions for FDA and CE marking, ensuring compliance with healthcare regulations. The ideal candidate should have a background in pharmaceutical sciences and experience with regulatory tools like eCTD. By outsourcing this expertise, companies can significantly reduce costs while ensuring compliance and accelerating time to market. This position offers a unique opportunity to work closely with teams internationally and contribute to regulatory success.