Soroush (Phd) Salmani
R&D Analytical Scientist and Regulatory Documentation Expert
Experience
R&D’s Analytical Scientist and Regulatory & Scientific Documentation Expert
Viatris Pharmaceutical Company
Regulatory Documentation and Compliance: Drafting the ANDA, IND, and IMPD documents. Reviewing and drafting the internal/external SOPs and analytical protocols to ensure compliance with FDA, EMA, ICH, and USP regulations and standards. Managing regulatory document workflows, tracking submissions, and verifying data accuracy using D2, Lorenz, and TrackWise (LIRs and CAPA) software.
Regulatory Process and Management: Support CMC regulatory submissions (Pre/Post Approval), optimize document submission workflows, and collaborate with regulatory and cross-functional teams to enhance compliance and efficiency.
Analytical and Technical Scientist: Support analytical, formulation, and process development teams. Provide analytical expertise for generic drug product development. Develop and validate chromatographic analytical methods for peptides and oligonucleotides. Conduct method transfers and perform complex analytical testing of APIs, raw materials, and stability samples. Provide scientific support for regulatory submissions and technical documentation and reports.
Utilized spectrometry techniques (ICP-MS/OES, AA, AMS) and analytical instruments qualification.
Applied chromatography techniques (HPLC, IC, LC-MS, GC), wet chemistry, SEC, RMM, DLS, ThT/fluorescence, and data analysis & statistics (SPSS). Familiar with LIMS, GMP, GLP environments, and adept in Empower, Chromeleon, and MassHunter.
Senior Lab Analyst/Technical Lab
ALS Lab
Implemented, maintained and operated new analytical instrumentation and standard laboratory equipment.
Developed and validated analytical methodologies for spectroscopy and extraction of elements in different geological matrices and chromatography techniques.
Mentored, trained and supervised laboratory staff and undergraduate students.
Wrote scientific reports and SOP project requirements.
Validated data from different analytical methods and analyses.
Ensured quality control was performed and reviewed quality control data for acceptability and trends.
Provided technical advice and assistance for clients according to project requirements.
Laboratory Technician
University of Extremadura
- Worked on an air quality control project funded by the Council of Extremadura.
Ph.D. Researcher and Scientific Collaborator
University of Extremadura
Identified and quantified pollutants (toxic trace elements and radioactive pollutants) in soil, air, urine, and blood samples.
Evaluated human and ecological risk assessments.
Used analytical methodologies: ICP-MS, microwave and ultrasonic bath and probe, Accelerator Mass Spectrometry (AMS), and Gamma-Ray Spectrometry.
Applied statistics and multivariate data analysis methods for data interpretation.
Collaborated on analysis and data interpretation of environmental samples (soil, air, plant) with international institutions and the Government of Extremadura.
Conducted research stays at Centro Nacional de Aceleradores (CNA) in Seville for analysis and monitoring of radioactive pollution in soil and plant samples.
Environmental Engineer
Mid Sweden University
Evaluated concentration and diversity of pathogens in sludge samples from the wastewater treatment system in Östersund, Sweden, in a project funded by the Östersund Municipality in Jämtland County.
Participated in international research stays in Europe and South America.
Refereed and reviewed scientific communications and articles.
Summary
Analytical R&D scientist and regulatory documentation expert with strong experience in global regulatory submissions, eCTD publishing, and compliance with FDA/EMA/ICH standards. Proven ability to manage submission workflows, coordinate legalization of documents, and ensure timely delivery and archiving of high-quality regulatory dossiers using tools like Lorenz, RIM, D2, and TrackWise. Strong background in analytical method development, CMC support, and cross-functional collaboration within GMP/GLP environments.
Skills
- Ectd Publishing Tools: Lorenz, Isitoolbox, Rim, D2
- Regulatory Systems: Trackwise, Fda Webtrader
- Analytical Platforms: Empower, Chromeleon, Masshunter
- Instrumentation: Hplc, Ic, Lc-ms, Icp-ms, Ams
- Software: Spss, Ms Office, Adobe Acrobat Pro
Languages
Education
University of Extremadura
PhD · Analytical Chemistry and Technology · Spain
University of Extremadura
M.Sc. · Analytical Chemistry · Spain
Mid Sweden University
M.Sc. · Environmental Engineering · Sweden
Certifications & licenses
Certified Attendance IC: Operation, Maintenance And Troubleshooting
Thermo Fisher
Certified Attendance H-Class/I-Class UPLC: Operation, Maintenance And Troubleshooting
Waters
Advance Practice In IC
Metrohm
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