Remote Pharmaceutical Regulatory Affairs Specialist

Placements24; Redmond (WA); Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Retirement savings plan

Professional development opportunities

Remote-first work environment

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory submissions

Regulatory strategy

Cross-functional collaboration

Document drafting

Project management

Education

Bachelor's or Master’s in a scientific field

PhD preferred

Tools

RIMs

eCTD publishing software

Job description

About the Role

Our client, a globally recognized leader in the pharmaceutical industry, is seeking a dedicated and experienced Remote Pharmaceutical Regulatory Affairs Specialist to contribute to their international compliance and product registration efforts. This fully remote position allows you to leverage your expertise from anywhere, focusing on ensuring that our client's innovative pharmaceutical products meet all necessary regulatory requirements across diverse global markets.

You will be instrumental in preparing, reviewing, and submitting regulatory dossiers, responding to health authority queries, and providing strategic regulatory guidance throughout the product lifecycle. The ideal candidate possesses a deep understanding of global regulatory landscapes, excellent attention to detail, and strong communication skills. This is a unique opportunity to join a forward-thinking company committed to ethical practices and global health advancements, all within a flexible, remote-first work environment. You will play a vital part in bringing essential medicines to patients worldwide by navigating complex regulatory pathways efficiently and effectively.

Key Responsibilities

• Prepare, compile, and review high-quality regulatory submission documents (e.g., CTD modules, INDs, NDAs, MAAs) for global health authorities.
• Manage and maintain regulatory filings and product registrations throughout their lifecycle.
• Liaise directly with regulatory agencies (e.g., FDA, EMA, MHRA) to address queries and facilitate the review process.
• Interpret and apply global regulatory guidelines and advise internal teams on compliance strategies.
• Conduct regulatory intelligence activities to stay informed about changes in the regulatory landscape and assess their impact.
• Review and approve labeling, promotional materials, and other product-related documentation for regulatory compliance.
• Collaborate with R&D, manufacturing, clinical, and commercial teams to ensure regulatory requirements are met at all stages of product development and commercialization.
• Contribute to the development of regulatory affairs policies and procedures.
• Participate in cross-functional project teams, providing expert regulatory input and strategic direction.
• Ensure post-approval commitments are met and managed effectively.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline. A Ph.D. is a plus.
• Minimum of 5 years of progressive experience in pharmaceutical regulatory affairs.
• Demonstrated experience in preparing and submitting regulatory dossiers for major markets (US, Europe).
• In-depth knowledge of ICH guidelines and regional regulatory requirements.
• Proven ability to interpret complex regulatory guidance and apply it to product development.
• Excellent written and verbal communication skills, with a talent for clear and concise documentation.
• Strong organizational and project management skills, with the ability to manage multiple projects simultaneously.
• Proficiency in regulatory information management systems (RIMs) and eCTD publishing software.
• Self-motivated, detail-oriented, and able to work independently in a remote setting.
• Experience with small molecules and/or biologics is desirable.

Benefits

Our client provides a highly competitive salary, reflective of the specialist skills required for this remote role.

Comprehensive benefits include medical, dental, and vision insurance, a generous retirement savings plan, and opportunities for professional development such as specialized training and conference attendance.

Employees enjoy the flexibility and autonomy of a fully remote work arrangement, enabling a strong work-life balance.

The opportunity to significantly impact global drug approvals and patient access to medicines from the convenience of your home office.

A culture that values collaboration, innovation, and employee well-being is core to our operations.