Remote Global Regulatory Affairs Specialist

Placements24; Redmond (WA); Hybrid; USD 110.000 - 160.000; Vollzeit

Benefits dieser Stelle

Medical, dental, vision insurance

Retirement savings plan

Professional development opportunities

Remote-first work environment

Zusammenfassung

Placements24 is seeking a Remote Pharmaceutical Regulatory Affairs Specialist to lead global regulatory submissions and strategy. The role focuses on US/EU markets, ICH guidelines, and cross-functional collaboration with R&D, manufacturing, and quality teams.

This fully remote position offers flexible work arrangements, competitive compensation, comprehensive benefits, and opportunities to impact patient access to medicines worldwide by navigating complex regulatory pathways efficiently.

Qualifikationen

• Minimum of 5 years of progressive regulatory affairs experience.
• Experience preparing/submitting regulatory dossiers for US/Europe.
• Strong knowledge of ICH guidelines and regional requirements.
• Ability to interpret complex guidance and apply to development.
• Excellent written/verbal communication and documentation skills.

Aufgaben

• Prepare, review, and submit regulatory dossiers (CTD, INDs, NDAs, MAAs).
• Manage regulatory filings and product registrations across lifecycles.
• Liaise with FDA, EMA, MHRA to address queries and facilitate reviews.
• Provide regulatory guidance to R&D, manufacturing, clinical teams.
• Monitor regulatory changes and advise on strategy and compliance.
• Review labeling and promotional materials for compliance.
• Collaborate cross-functionally to meet development milestones.
• Support post-approval commitments and lifecycle management.

Kenntnisse

Regulatory submissions

Regulatory strategy

Cross-functional collaboration

Document drafting

Project management

Ausbildung

Bachelor's or Master’s in a scientific field

PhD preferred

Tools

RIMs

eCTD publishing software

Jobbeschreibung

Placements24 is seeking a Remote Pharmaceutical Regulatory Affairs Specialist to lead global regulatory submissions and strategy. The role focuses on US/EU markets, ICH guidelines, and cross-functional collaboration with R&D, manufacturing, and quality teams.

This fully remote position offers flexible work arrangements, competitive compensation, comprehensive benefits, and opportunities to impact patient access to medicines worldwide by navigating complex regulatory pathways efficiently.