Job Description
The Regulatory Affairs Associate or Specialist will be primarily responsible for compiling and publishing regulatory files in support of product registrations mainly in the US, however some International filings may be possible. In addition the jobs will entail preparation of SOPs, specifications, document management and support of our propriatary eCTD software.
Essential Functions
- Compile and publish high eCTD submissions for DMFs, ANDAs, INDs and NDAs to established timelines.
- Maintain the regulatory submission lifecycle including original submissions, amendments, supplements, labeling, annual reports and other associated correspondence.
- Be able to work effectively on multiple projects simultaneously and with people both in the US and abroad.
- Maintain and work to Company SOPs.
- Maintain up-to-date knowledge on international and domestic regulatory requirements.
- Provide technical support Aspire, Custopharm's propriatary eCTD software.
- Other duties as assigned by supervisor.
- Willingness to wear many hats and do what is needed to get the job done.
Qualifications and/or Work Experience
- Minimum 1-3 years experience in pharmaceuticals with at least one in regulatory affairs.
- Bachelor's Degree or equivalent work experience, preferably in a scientific or technical discipline.
- Working knowledge of FDA and international regulations.
- Proficiency with Microsoft Office.
- Strong questioning and problem-solving skills.
- Strong interpersonal skills required in areas of verbal and written communications, service to internal customers, and professionalism.
- Effective written and oral communication, technical writing and editing skills.
- Ability to work independently with minimal supervision.
General office environment with extensive use of computer. Some travel required.
Please contact send your resume/CV to jobs@custopharm.com.