• Regulatory Affairs Specialist (Global)

    Astrix Technology (Los Angeles, CA)


    Regulatory Affairs Specialist (Global)

     

    Regulatory Affairs

     

    Los Angeles County, CA, US

    Pay Rate Low: 65 | Pay Rate High: 80

    + Added - 15/10/2024

     

    Apply for Job

     

    One of our innovative clients who specializes in the Nutraceutical space is seeking a Sr. Regulatory Affairs Specialist (Global) to help expand portfolio. This is a great opportunity for individuals who are looking for a new challenge with full autonomy & ability to build out their own team.

     

    Direct Hire Position (Salary range: $100-150K+ DOE)

     

    Relocation assistance may be provided.

     

    Equity included in compensation package.

    Responsibilities:

    + Prepare & maintain necessary documentation for regulatory submissions, inspections and import activities.

    + Ensure compliance with licensing regulations in all applicable jurisdictions.

    + Responsible for maintaining relationships and working with suppliers.

    + Manage regulatory assessment and guidance on product compliance topics including change controls, deviations and GMP investigations.

    + Responsible for providing regulatory support and guidance to cross-functional teams and key stakeholders.

    + Assist in determining regulatory requirements for registration, approval, and maintenance of existing drugs and potential new drug products in global markets.

    + Establish clear priorities and bring key projects to completion on time, within budget and of significant impact to the growth of the business.

    + Provide technical support and expertise on API related, IND/NDA, and 503A/503B.

    + Effectively communicate project needs and deliverables to upper management as needed.

    Requirements:

    + PharmD Degree and active pharmacy license.

    + Strong proven hands-on regulatory affairs experience with APIs.

    + Strong knowledge of 503A & 503B regulations.

    + Effective planning, organizational and task management skill

    + Detail-oriented and goal-driven individual

    + Excellent facilitation and creative problem-solving skills

    + Excellent communication skills while simultaneously being able to work independently

    + Demonstrated ability to prepare complex documents/submissions and presentations

    INDBH

    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.