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Regulatory Affairs Specialist

LGM PHARMA SOLUTIONS LLC

Regulatory Affairs Specialist

Irvine, CA
Full Time
Paid
  • Responsibilities

    LGM Pharma is a leading contract development and manufacturing organization (CDMO) and provider of Active Pharmaceutical Ingredients (API). With excellent API sourcing and supply chain expertise together with our drug product contract development and manufacturing solutions, we are a premier end-to-end solutions provider to the global pharmaceutical industry.

    We are a high-growth organization looking to accelerate the development and commercialization of high-quality therapeutics worldwide. We have offices in California, Texas, Kentucky, Florida and Israel.

    We are looking for a Regulatory Affairs Specialist to join our Quality Department, in Irvine, CA.

    REQUIRES ONSITE WORK WITH THE POSSIBILITY FOR SOME REMOTE WORK AFTER TRAINING.

    RESPONSIBILITIES:

    PLANNING:

    • Provides regulatory assistance during the ANDA/NDA submission and approval process.

    • Assists in company Standard Operating Procedures (SOP’s) development and review.

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

    PRE-MARKET:

    • Assists in reviewing documents for regulatory compliance necessary for the acceptability of quality documentation for submission filing.

    • Assists in developing pre-approval compliance activities during manufacturing of submission batches.

    • Performs label development and reviews for compliance.

    • Monitors impact of changing regulations on submissions.

    • Monitors and submits applicable reports to regulatory authorities as required.

    POST-MARKET:

    • Maintains annual licenses, registrations, listings and patent information as required.
    • Prepare annual reports for NDA/ANDAs by scheduling and coordinating receipt of documentation/information, preparing cover pages describing changes made to an application and tracking progress of their preparation.
    • Review of documents and interacting with multiple departments (QA, Manufacturing, Project Management, Engineering, PD, etc.) which provide information and documentation utilizing the change control database to ensure accurate reporting to FDA.
    • Assist in maintaining approved NDA/ANDAs current by requesting revisions to technical documentation as part of the annual report preparation process.
    • 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.
    • Assist in the preparation, revision and approval of labeling.
    • Assist in the preparation and submission of required post approval reports such as field alert reports, periodic adverse drug experience reports etc. Ensures product safety issues and product-associated events are reported to regulatory agencies.
    • Ensures compliance with product post-marketing approval requirements, annual reports, drug listings, labeling, pharmacopeia changes (pre and post approval), etc.
    • Reviews regulatory aspects of contracts with customers.
    • Provides regulatory support for product recalls and recalls communications.
    • Other related duties as required.

    QUALIFICATIONS:

    • Bachelor's degree in science (biology, chemistry, microbiology, and pharmacy).
    • 10+ years’ of experience in a regulatory function within pharmaceuticals (preferred) or medical products; experience in quality assurance and/or compliance may be considered.
    • Certification such as RAC from the Regulatory Affairs Professionals Society preferred.
    • Experience with electronic regulatory submissions.
    • Knowledge of USP, and Code of Federal Regulations 21 CFR 111, 11, 210, and 211. FDA/ICH guidance and the regulatory process pertaining to drug development and approval.
    • Able to handle multiple high priority assignments.
    • Advanced technical writing skills and acute attention to detail.
    • Strong knowledge and understanding of CMC.
    • Ability to read and interpret complex technical documents. Ability to write comprehensive reports.
    • Strong communication skills, both written and verbal.
    • Able to build rapport at all levels of the organization as well as with external contacts.
    • Strong computer skills. Proficient in MS Office suite of products (Word, Excel, Powerpoint, etc.)