Drug Regulatory Affairs Specialist - Hyderabad - DataSphere Solutions Private Limited

    DataSphere Solutions Private Limited
    DataSphere Solutions Private Limited Hyderabad

    3 hours ago

    Technology / Internet
    Description

    Registrar Corp's mission is to promote consumer health and safety by providing over 35,000 food, cosmetic, medical device, and drug clients in 180 countries with compliance software and services. We're a fast growing team spanning 21 offices worldwide and always looking for talented and dedicated professionals to join us.

    We are currently seeking a Regulatory Specialist to support our pharmaceutical clients worldwide. This role is ideal for someone with a strong foundation in pharmaceutical regulations and a passion for helping companies navigate complex compliance landscapes. You will play a key role in supporting regulatory submissions for our clients to the U.S. FDA and other respective agencies as needed. The regulations are always evolving and with that the systems the agencies utilize change. Problem solving is an everyday occurrence.

    If you have exceptional attention to detail, solid organizational skills, and enjoy communicating with international clients – We encourage you to apply today for our Drug Regulatory Specialist position

    Role Responsibilities

    • Customer Communication: Communicate with international customers via phone and email.
    • Agency Communication: Professional mannerisms to provide information to the agency to assist with a client's need.
    • Document Control: Retrieve and compile information as requested from records, emails, and other documents.
    • Data Management: Perform administrative and data entry tasks, including analyzing and interpreting Microsoft Excel data and managing databases.
    • Quality Assurance: Review forms, data, and other information to ensure accuracy and conformance to established procedures and policies.
    • Regulatory Compliance and Submissions: Verify data for accuracy, completeness, and compliance with established procedures to submit data to the federal government. Compile and submit data to regulatory authorities in compliance with established procedures.

    Required Skills and Experience

    • At least 2 years of experience working in regulatory affairs, compliance, customer service, administrative, or data entry-driven role.
    • Strong problem-solving and critical thinking skills.
    • Fluent in English language (strong writing & oral skills) to be able to communicate with clients directly.
    • Ability to diagnose client needs and build relationships through a consultative approach.
    • Quick adaptation to evolving technology systems.
    • Understanding of drugs regulations (FDA).
    • Experience with Atlassian products such as Jira and Confluence.
    • Experience with FDA systems (FDA Direct, NextGen Portal, ESG Nextgen Portal)

    Preferred Skills

    • Education with a Degree in Life Sciences Discipline. Chemistry is highly preferred.

    Shift Expectations

    • 5 hours (Mon. – Thurs.) & 8 hours (Fri.) within India's business hours
    • 8 AM to 11 AM EST for team meeting, support & training (Mon. through Thurs.)
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