• Regulatory Affairs Specialist (Submissions)

    Astrix Technology (PA)


    Regulatory Affairs Specialist (Submissions)

     

    Regulatory Affairs

    Remote, PA, US

    Pay Rate Low: 70.00 | Pay Rate High: 75.00

     

    + Added - 06/05/2025

     

    Apply for Job

     

    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 in Life Sciences or 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 standar

    + Skilled in project coordination, communication, and cross-functional collaboration

    + Detail-focused, organized, and deadline-driven

     

    Pay: $65-75/hr

     

    This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

     

    We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.