X-GEN Pharmaceuticals, Inc. continues to experience steady growth and this results in rewarding employment opportunities for candidates with the right skills. X-GEN Offers Pay and Benefits that Include: Vacation, Simple IRA, Professional Growth, Advancement and Health Insurance.
Available Positions (1)
Title: Regulatory Affairs Specialist I
Reports to: Regulatory Affairs Manager
This position will perform the actions necessary for full regulatory compliance for all drug products, from initial FDA regulatory submittal through the end stages of the product life cycle. Daily Regulatory Affairs responsibilities include drug product labeling, annual product reports, post-approval requirements, ANDA filings and post approval submissions.
Essential Duties & Responsibilities:
- Use pre-established guidelines with assistance creates regulatory submissions related to the maintenance of ANDAs such as quarterly and annual reports, while learning to meet submission commitments and deadlines.
- Participates in the development, monitor and implement technical applications required to most efficiently transmit regulatory submissions.
- Collaborate with Contract Manufacturers (CMs) to obtain technical information/documentation and implement changes for compliance with current regulations.
- Collaborate with other departments within the company to obtain technical information/documentation and implement changes to comply with current regulations.
- With assistance reviews SOPs, protocols, technical documents, labeling, data and reports to ensure suitability for regulatory filing.
- With assistance develops printed product labeling and coordinate labeling changes and manage communication with CM and labeling artwork supplier. Coordinate the filing of all labeling changes.
- Travels to training and may accompany other Quality or Regulatory personnel to CMs or agency sponsored meetings.
- Monitor and investigate change in the regulatory environment through direct interaction with regulatory agencies, attendance at trade seminars, routine review of the federal register, FDA Internet updates and other trade publications to assess the impact on internal operations.
Qualifications / Requirements:
- Moderate knowledge of word processing, spreadsheet, database, internet, electronic document management systems and be familiar with electronic submissions software.
- Strong computer skills including Adobe Acrobat Professional, Excel, MS Word, Powerpoint.
- Must be highly organized and possess strong communications and facilitation skills.
- Regulatory Affairs and Regulatory Operations experience desirable.
- Must have the ability to work with minimal supervision.
- Traveling required as necessary to support your job functions
- Bachelor’s degree, or Two Year Associate degree in Chemistry, Biochemistry, Biology, or combination of the above.
- 0-2 years of Direct Regulatory Affairs Experience desired
If you would like to submit a resume for future consideration, please use the form below.
300 Daniel Zenker Dr
Horseheads, NY 14845
+1 (866) 390-4411