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Newtown

    Regulatory Group Leader - Newtown, United States - K V K Tech

    K V K Tech
    K V K Tech Newtown, United States

    2 weeks ago

    Default job background
    Description
    Job Description

    Job Description

    Department
    Regulatory Affairs
    Job Title
    Group Leader
    FLSA Status
    Exempt
    Reports To
    Direct of Regulatory Affairs

    1.


    Role Purpose:


    Primary responsibilities are to manage, prepare and submit regulatory submissions by successfully coordinating with the Manager for priorities; while maintaining compliance with cGMP requirements, FDA, OSHA, EPA, and DEA.

    2.


    Key Duties & Responsibilities:
    Trains Regulatory Associates
    Collaborates with R&D, QC and Production Managers
    Handles all aspects of regulatory submissions (i.e. ANDA and NDA)
    Assists associates, coordinators, analysts, auditors and specialists as needed
    Handles and completes special projects as required
    Comply with FDA guidelines/Company Policies of Data Integrity
    Other duties as required or delegated

    3.


    Typical Supervisory Responsibility:


    Serves as an effective member of the Regulatory Affairs team and may serve as a mentor to other regulatory employees in the area of expertise.

    4.


    Education & Experience:
    Education Requirement
    Specialization (If any)
    Bachelor's Degree in Pharmacy, Chemistry or Scientific Discipline preferred

    Experience Requirement
    5.


    Technical competencies/ Certifications/ Licenses:
    Technical competencies
    At least - 3 years' experience with technical writing preferred
    Minimum 5 years Pharma experience preferred
    Strong communication and problem-solving skills
    Proficient with Adobe PDF, Microsoft Office, XML, eCTD tools and advanced computer skills
    Continuous working knowledge of applicable FDA/ICH/DEA regulations
    Continuous working knowledge of applicable cGMP guidelines

    6.

    Physical demand and

    Work environment:
    a.


    Physical demands:


    While performing the duties of this job, the employee is required to walk, sit, and use hands to finger, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear.

    The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception.
    b


    Work environment:
    N/A

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