Senior Regulatory Affairs Specialist

    • Job Tracking ID: GL20
    • Job Location: Allentown, PA
    • Job Level: Any
    • Level of Education: Any
    • Job Type: Full-Time/Regular
    • Date Updated: January 04, 2019
    • Years of Experience: Any
    • Starting Date: ASAP
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Job Description:

Position: Senior Regulatory Affairs Specialist (prepares submissions for ANDAs and/or NDAs)


- Prepare submissions for New Drug Applications (NDAs) according to FDA regulations.

- Develop and assess strategies for regulatory approvals for NDAs by providing input from product development through commercialization.

- Prepare controlled correspondence to FDA.

- Provide technical writing for NDAs, supplements, amendments etc.

- Collect and organize necessary documentation to be included in NDA submissions, reports, etc.

- Prepare the Quality Overall Summary and all eCTD module submission documentation for NDA filings.

- Prepare responses to information requests, amendments, complete response letters, supplements, etc. associated with NDA submission and submit to FDA.

- Review NDA submission documentation to ensure that all current FDA guidelines are met.

- Prepare and maintain a correspondence log for each NDA submission.

- Coordinate eCTD submission of NDA’s between Genus and any outside contracted company.

- Provide regulatory input for the product development and submission process for NDA submissions.

- Prepare annual reports for NDAs in accordance with 21 CFR 314.81.

- Review documents and interact with multiple departments (QA, AS, Engineering, PD, etc.) which provide information and documentation to ensure accurate reporting to FDA.

- Provide a critical detailed review of technical documentation including labeling, distribution reports, analytical procedures, product specifications, manufacturing and packaging batch records, in-process specifications, etc. prior to FDA submission.

- Track NDA commitments made to FDA to ensure commitments are completed and reported in a timely manner.

- Maintain and ensure all NDA documentation is filed properly.

- Maintain and manage product specific checklists to ensure that all required documentation and information is available, accurate and complete for submission.

- Assist in the preparation and submission of required post approval reports such as quarterly and annual periodic adverse drug experience reports, post commitment requirements, etc.

- Maintain current knowledge of FDA regulations and guidance’s pertaining to changes to approved NDA regulatory applications.

- Provide oversight of clinical studies in support of NDA submissions.

Experience and Skills:

  • Physical Requirements:

    • Physical activities include, but are not limited to, repetitive motions. Substantial movements (motions) of the wrists, hands, and/or fingers.
    • The physical requirement is sedentary. Exerting up to 10 lbs. of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. Sedentary works involves sitting most of the time. Walking and standing are required only occasionally.
    • The employee is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes.
    • The employee is not substantially exposed to adverse environmental conditions


    Equal Opportunity Employer


    Please include salary requirements with your resume


Innovation drives our strategy. Perseverance propels our success.

Genus Lifesciences™ is a specialty pharmaceutical company engaged in the development and commercialization of generic and branded pharmaceutical products. Founded in 1999, Genus Lifesciences™ employs over one hundred fifty professionals in all phases of pharmaceutical operations, and its products are available in pharmacies and other retail outlets throughout the United States. In addition to its local presence, Genus Lifesciences™ has on-going research efforts through global partnerships related to its technology platforms.