Regulatory Affairs, Associate

Year    Hyderabad, Telangana, India

Job Description


Cellix Bio employees and teams apply sound science to develop and deliver medicines that focus on unmet medical needs around the world. Our current prescription products at various stages of development target to serve patients across therapeutic areas including metabolism, immunology, infectious diseases, neuroscience, ophthalmology, and oncology. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. You will help make an impact on people\xe2\x80\x99s lives and change futures every day. We are equally committed to bringing out your best and fostering a collaborative workplace built on trust and respect. We empower our people to take charge of their potential. We offer training and leadership development programs tailored to help you build valuable skills and succeed in your career. As you discover your potential, your professional and personal future will become brighter. Forward your CV / Resume : careers@cellixbio.com

REGULATORY AFFAIRS, Associate The candidate will be expected to prepare and review many types of documents for submission to the FDA, including the following (not an all-inclusive list), in a format compliant with FDA standards. In addition, the candidate will be expected to communicate with FDA and represent the Regulatory Affairs department in cross functional team meetings and must possess a strong understanding of regulations and guidances. The applicant will assist in determining regulatory strategy for new submissions and post-approval changes. The ideal candidate must have experience with thoroughly reviewing documentation required for 505(b)(2) submissions for accuracy and completeness, and successfully communicating with FDA and other stakeholders (internal and external). The candidate must have the ability to work independently and manage/prioritize projects to ensure targeted timelines are met. A minimum of 2 years\' experience in Regulatory Affairs with a Bachelor\'s / Master\'s degree, preferably in Chemistry or a related, scientific discipline. Experience with Adobe Acrobat and Windows-based programs such as Microsoft Word, Excel, and SharePoint is required.

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Job Detail

  • Job Id
    JD3029882
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Hyderabad, Telangana, India
  • Education
    Not mentioned
  • Experience
    Year