Regulatory Operations Principal Specialist

Job overview

Scientific and project responsibilities

• Support analytical and comparative dissolution projects; coordinate with CROs and other project stakeholders to meet timelines.
• Design experiments, monitor lab work, and recommend investigation changes based on results and scientific information.
• Prepare test methods, technical documents, protocols, and reports; record, retain, summarize, and interpret data.
• Analyze dissolution datasets and troubleshoot instruments and methods.
• Perform assigned work in accordance with GMP and safety requirements.

Client, quality, and team responsibilities

• Work with clients to support satisfaction, transitions, delivery, and service-level agreements.
• Develop SOPs and training materials with Quality Assurance; assist with training and mentoring.
• Participate in audits, process improvements, cross-functional meetings, and operational problem solving.
• Support resource assignment, team performance management, project objectives, and procedure implementation.

Qualifications and experience

• Bachelor’s degree in pharmacy or related science, or equivalent; advanced degree with experience is also described.
• Alternative packaging pathway: relevant engineering, B.Tech, packaging, polymer, or printing education plus 7–9 years of packaging experience, or a packaging postgraduate qualification, diploma, or certification with 7–9 years of experience.
• Typically 7–9 years in a relevant discipline, such as Regulatory Affairs, Quality Assurance, analytical science, or packaging.
• Experience in multimedia dissolution testing and knowledge of FDA-SUPAC, ICH, and other applicable regulatory guidelines.
• Hands-on analytical technique experience, including HPLC, GC, UPLC, KFT, or particle-size measurement, and troubleshooting.
• At least one year of project and people management experience is desirable; equivalent relevant experience may be considered in lieu of education requirements.

Skills

• Strong analytical, scientific, and project-management skills; effective communication and presentation; decision-making and collaborative planning and execution.
• English and/or other languages as applicable.