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Job type: Contract

Discipline: Project Manager

Location: United States

Regulatory Submission Project Management, Senior Specialist - Contract - Remote

Are you a dedicated individual looking to put your expertise to work fully flexibly in a remote position?

��Ƶ is seeking a Senior Specialist for Regulatory Submission Project Management to support the management of Clinical Trial Applications (CTAs) and related health authority submissions.

Primary Responsibilities:

This role involves collaboration with internal teams, external partners, and stakeholders to ensure efficient document handling and communication. You will play a key role in tracking deliverables, managing regulatory communications, and supporting submission activities.

Skills & Requirements:

Familiarity with regulatory agency regulations and guidelines (e.g., FDA, EMA, ICH, eCTD).
Experience managing global Clinical Trial Applications (e.g., IMPD preferred).
Understanding of pharmaceutical drug and device development processes.
Knowledge of regulatory affairs, operations, or information management.
Practical experience with RIM technologies is a plus.
Strong organizational skills with the ability to manage multiple projects simultaneously.
Excellent written and verbal communication skills.
Self-motivated, detail-oriented, and capable of working both independently and collaboratively.
Critical thinking and adaptability to project needs.

The Senior Specialist's responsibilities will be:

Track Clinical Trial Application (CTA) submission deliverables and maintain updates across platforms.
Download CTA deliverables from various CRO systems and communicate updates to stakeholders promptly.
Collect, upload, and manage regulatory agency communications (e.g., emails, phone conversations, letters) within the Veeva Vault RIM repository.
Conduct brief reviews of regulatory packages and track any issues or gaps in data collection.
Manage CTA regulatory submission-document transfers between internal teams and CROs, including scheduling meetings and follow-up communication.
Support tracking of Reference Safety Information (RSI) approvals by global health authorities and assist the Global Pharmacovigilance Planning Team.
Collaborate with cross-functional teams and stakeholders to ensure smooth documentation processes.
Communicate regulatory system enhancement needs or technical issues as identified.

Compensation:

$50 to $60 per hour.

If you are having difficulty in applying or if you have any questions, please contact Bo Forsen at b.forsen@proclinical.com

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

��Ƶ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. ��Ƶ is acting as an Employment Agency in relation to this vacancy.

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