Hikma Pharmaceuticals USA Inc.

  • Mgr, Regulatory Affairs

    Job Location US-NJ-Cherry Hill
    Posted Date 4 months ago(7/6/2018 11:48 AM)
    Job ID
    2018-4487
    Job Function
    Regulatory Affairs
    Shift
    Cherry Hill First Shift
  • Overview

    Responsible for defining detailed regulatory strategies and submissions in support of new and existing marketing authorizations for products at one or more manufacturing facilities.  This position ensures timely review of documents, submissions and FDA follow up.  

    Responsibilities

    1. Develop, communicate and execute regulatory strategies for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations. Review and approval of changes controls and documents (batch records, specifications, analytical methods, development reports, protocols, etc.) for regulatory submission and compliance to FDA submission standards (RTR).
    2. Active role in the generation and intradepartmental review of new submissions, supplements, amendments and annual reports. Support resolution of deficiency comments (CRLs and IRs) from the Agency.
    3. Represent or lead the RA function on assigned cross-functional project teams. Ensure project teams and business objectives and deliverables are aligned with regulatory strategy.
    4. Monitor applicable regulatory requirements; assure compliance with company and external standards. Provide timely interpretations of applicable Agency guidance documents and support rollout across the organization.
    5. Establish appropriate communication with the Agency, and relay concise information within RA and other functions, primarily at project level.
    6. Ensure that labeling is compliant with regulations, and in agreement with Reference Listed Drugs. Will prepare and submit labeling as necessary.
    7. Develop and document sound regulatory decisions and justifications.
    8. May review promotional material or SOPs for compliance with local and global regulations.

    Qualifications

    BA/BS degree in related scientific discipline with a minimum of 6 years’ experience in RA.  Injectable dosage form experience is prefered and knowledge of device regulations is a plus.

    1. Sound understanding of U.S. Drug Regulations. Strong knowledge of both pre and post approval regulatory submission requirements.
    2. Scientific knowledge of the pharmaceutical development and manufacturing processes.
    3. Ability to manage complex projects and timelines in a matrix team environment.
    4. Strong oral and written communication and presentation skills.
    5. Demonstrated interpersonal skills including strong negotiation skills.
    6. Ability to independently identify compliance risks and escalate when necessary.
    7. Ability to lead and coach others. Will be responsible to mentor and assist in the development of RA staff.

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