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Job

Senior Associate, Regulatory Affairs

  • Location

    Remote

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Antoinette Miller

  • Contact email:

    a.miller@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    4 months ago

  • Expiry date:

    2022-05-15

  • Startdate:

    ASAP

Essential Functions of the Job:

  • With minimal supervision, plan and manage regulatory activities related to assigned projects that span technical areas including clinical and non-clinical.
  • Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects.
  • Manage the preparation, including writing as necessary, assembly, review, and timely submission of regulatory dossiers as required for investigation and registration of products in the US and abroad.
  • Ensure regulatory submissions are maintained in compliance with regulatory requirements. Support and manage preparation of meeting requests and briefing documents.
  • Manage the preparation, review, and submission of all components of regulatory submissions including INDs and amendments, BLAs/NDAs and supplements, annual reports, safety reports, etc. Participate on project teams and provide expertise on regulatory matters.
  • Develop and maintain current regulatory knowledge and advise management of significant developments. Prepare and maintain regulatory archive. Work with external regulatory consultants/CRO’s as required.

 

Qualifications:

  • Two to three years of experience in the pharmaceutical industry
  • Understanding of FDA structure and function. Knowledge/experience with regulatory requirements for other regions also desirable.
  • Working knowledge of GMP, GLP, and GCP regulations as well an understanding of the pharmaceutical product life cycle. Excellent oral and written communications skills are a must as are superior planning skills.
  • Experience and knowledge in preparation of INDs (required) and NDAs (desirable), and supportive amendments and supplements (nonclinical, clinical).
  • Experience with CTD/eCTD. Experience with publishing documents in Adobe Acrobat Professional. Working knowledge of FDA and ICH regulatory guidance and regulations.
  • The candidate should be detail-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.

 

Education Required: BA / BS in Health Science, preferred