DESCRIPTION: Conduct analytical runs for R&D purposes using a set of analytical techniques such as HPLC, UPLC, GC, including writing related protocols and reports. Develop, evaluate, validate analytical methods for raw materials and finished products. Support the transfer of developed and qualified assays to relevant clients. Provide support, as related to analytical, plant trouble shooting/investigations and product regulatory submission. Provide full analytical development support in accordance with cGMP/GLP practices to product development programs within strict timelines to successfully meet internal and client program milestones. Support the AR&D related activities for filing of new ANDA. Support the generation of pharmaceutical development reports and related documentation.
REQUIREMENTS: Master's in Chemistry or Biochemistry. 1 year experience in job offered or 1 year experience as Analytical Research Scientist, Analytical Chemist or any suitable combination of experience/education/training.
The Senior Regulatory Affairs Associate will review and prepare regulatory documents related to ANDA submissions. Prepare submissions for projects/products covering product development, registration, approval and post approval activities for ANDAs/NDAs. This individual will be part of project teams, and provide Regulatory insight and direction. Review and compile Regulatory submissions. Must have excellent written and effective verbal communication skills, be proficient in project management, and be a flexible individual able to work in a fast paced environment.
This is an Exempt, Salaried position.
2 – 3 years experience in pharmaceutical regulatory affairs.
Experience in Generic Regulatory filings preferred.
Author and compile Regulatory filings including new ANDA/NDA submissions, amendments, supplements, annual reports, safety reports.
Review all source documentation for scientific and regulatory requirements.
Review and communicate emerging regulatory requirements to ensure compliance.
Represent Regulatory Affairs in cross functional meetings.
Interface with external regulatory groups and regulatory agencies.
Other daily, weekly, monthly etc., reports, tasks, projects as required in the Regulatory Affairs Department.
Epic Pharma is an equal opportunity employer and offers a competitive starting salary and benefits package including medical/dental/vision/401k.