Regulatory Affairs Specialist in Durham, NC with Greene Resources

Date Posted: 12/23/2020

Job Snapshot

Job Description


Job Number: 39926


Regulatory Affairs Specialist


Job Description:

We are seeking a Regulatory Affairs Specialist to join our client, a renowned global non-profit aimed at researching and improving the human condition. This person will be responsible for providing regulatory guidance, supplemental writing, and review of clinical reports and pertinent regulatory submission for sections for Drugs, Biologics, or Diagnostic Development projects. This is a Direct Hire opportunity that offers a comprehensive benefits package and the flexibility to offer a competitive salary based on experience.


Responsibilities:


  • Plan and oversee regulatory activities for drug development; provide expertise and strategy, to multi-functional project teams as a regulatory contact

  • Provide regulatory assistance or serve as FDA regulatory contact for clients

  • Write and support the preparation of regulatory documents required to support clients' global drug development and registration activities

  • Serve as the medical writing representative on assigned product teams and closely collaborate with personnel from clinical, regulatory, and scientific departments

  • Manage the regulatory submission process and regulatory agency interactions with a regulatory team

  • Working with a project coordinator, ensure maintenance of each product development program?s applications and documentation, per regulations

  • Ensure CRO and consultant deliverables and activities are prepared or conducted on time and of high quality

  • Prepare planning, strategy, summary documents, etc. for use in communicating with product developers

  • Ensure compliance with GCP, GMP, and regulatory guidelines

  • Identify short and long-term project needs, formulate plans for satisfying those needs, and identifying resources to implement project plans

  • Conduct internal and external business-development activities to raise the profile of Global Health Technologies? drug development capabilities. These activities will include the preparation of proposals for submission to funding agencies


Education Requirements:


  • Master's degree in a scientific or technical discipline with 3+ years' experience in biopharmaceutical drug development or clinical affairs; OR a Bachelors? degree with 5+ years' experience in biopharmaceutical drug development or clinical affairs.


Desired Background/Skills:



    Qualifications:


    • 3-5 years experience in biopharmaceutical drug development or clinical affairs

    • Experience with FDA interactions and/or other regulatory authorities

    • Excellent oral and written communications skills

    • Ability to work as a member of multiple project teams and achieve consensus in diverse groups

    • Ability to prioritize and multi-task concurrent project demands


    Other Information:




      Greene Resources is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.