Regulatory Affairs Specialist (Submissions)

Astrix Inc.; Pennsylvania; Remote; USD 60,000 - 80,000; Full time

Job summary

An innovative biopharmaceutical company is searching for a detail-oriented Regulatory Affairs Specialist to manage global regulatory submissions. This fully remote role offers the opportunity to work with cross-functional teams and leverage Veeva RIM for submission planning and execution. The ideal candidate will have a strong background in regulatory submission management and be adept at ensuring compliance with global standards. Join a forward-thinking organization dedicated to transforming patients' lives through groundbreaking therapies and make a significant impact in the field of regulatory affairs.

Qualifications

• 3+ years in regulatory submission management (US, EU, global).
• Strong knowledge of eCTD and global submission standards.

Responsibilities

• Lead and coordinate global regulatory submissions (INDs, NDAs, BLAs).
• Ensure submission quality by collaborating with internal teams.

Skills

Regulatory Submission Management

Project Coordination

Communication Skills

Cross-Functional Collaboration

Detail Orientation

Education

Bachelor’s degree in Life Sciences

Tools

Veeva RIM

Job description

Regulatory Affairs Specialist (Submissions)

Position: Regulatory Affairs

Location: Remote, PA, US

Pay Rate: $70.00 - $75.00 per hour

Our client, a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases, is seeking a Regulatory Specialist to join their team as a consultant. This position is fully remote.

Summary:

Seeking a detail-oriented specialist to manage global regulatory submissions (FDA, EMA, and others). This role focuses on end-to-end submission planning and execution, leveraging Veeva RIM and cross-functional collaboration to ensure timely, compliant filings.

Key Responsibilities:

• Lead and coordinate global regulatory submissions (INDs, NDAs, BLAs, MAAs, etc.)
• Ensure submission quality by working with regulatory, clinical, CMC, labeling, and publishing teams
• Manage submission data and records using Veeva RIM
• Support Veeva RIM configuration and optimization
• Track timelines, mitigate risks, and report status across projects
• Stay current on global regulatory requirements and standards
• Liaise with internal teams and external vendors for smooth execution

Qualifications:

• Bachelor’s degree in Life Sciences or a related field
• 3+ years in regulatory submission management (US, EU, global)
• Proficient in Veeva RIM; configuration experience is a plus
• Strong knowledge of eCTD and global submission standards
• Skilled in project coordination, communication, and cross-functional collaboration
• Detail-focused, organized, and deadline-driven

Note: Our client encourages candidates with some of these skills to apply. We look forward to a conversation to learn more about you!