Regulatory CMC Associate – Temporary

  • FTC (Fixed Term)
  • Anywhere
  • Posted 3 months ago

JOB DESCRIPTION:

The Regulatory Chemistry, Manufacturing, and Controls (CMC) Associate is a dynamic individual who is interested in drug development, Regulatory CMC, and able to navigate a fast-paced environment. The Regulatory CMC Associate is responsible, with supervision, for supporting tracking and planning of regulatory submissions for marketed products or products in development. The Regulatory CMC Associate is responsible to help to ensure quality control of assigned submissions to ensure timely and quality submissions. 

ESSENTIAL DUTIES & RESPONSIBILITIES:

Assist in planning regulatory CMC submissions globally including Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), New Drug Applications (NDAs), New Drug Submissions (NDSs), and Marketing Authorization Applications (MAAs) based on regulatory guidance, regulations, and directives.
Management of CMC regulatory commitments, change controls, and change actions for amendments, as needed.
Assist in researching and authoring content for annual reports for INDs/NDAs for assigned products.
Provide general administrative support including formatting, Veeva processing, and review of published output submission documents for submissions.
Review the FDA Form 356h for Regulatory CMC submissions, as needed.
Manage document QC activities for CMC Ensure subject matter experts (eg, Manufacturing, Pharmaceutical Sciences, Quality Control, Regulatory Operations, GMP QA) have provided references and that information is available and organized for the QC person.
Responsible during the document QC for liaising with subject matter experts to obtain additional information as needed to allow for timely QC completion. Responsible for coordinating the QC comment resolution, including any necessary follow up with subject matter experts.
Ensure submissions are QC’ed within the established timelines. Proactively work to resolve issues, as appropriate. Inform of any risk to the timelines.
Review labels and specifications, as requested.
Regularly meet with supervisor to discuss status of activities and potential issues or recommendations
Recognize the need to seek assistance or inform supervisor or head of Regulatory CMC of specific issues.
Other duties as requested by supervisor.

REQUIREMENTS:
Scientific degree is required.
Excellent verbal and written communication skills are required.
Strong attention to detail and organizational abilities is required.
A minimum of 1 year experience in regulatory CMC
Demonstrated interest in the drug development and regulatory CMC.
Excitement about Heron’s mission to develop best-in-class medicines and improve lives.
Demonstrated ability to work independently and in a team environment.
Willingness to work in a dynamic and changing corporate environment.
Proficiency with MS Office, especially Word, Excel, SharePoint, and PowerPoint experience.

You can apply to this job and others using your online resume. Click the link below to submit your online resume and email your application to this employer.