Dr. Sandip Kaur Badyal

•Solely implemented an ISO 13485 Quality Management System within 6 months and was responsible for maintenance of the QMS across SharePoint •Effectively managed all regulatory, quality control and quality assurance related aspects of the business globally •Positively managed interactions with various health authorities and notified bodies •Conducted third party/supplier audits for compliance purposes •Conducted independent investigations to resolve complex issues

• Successfully developed and executed marketing campaigns to deliver on STEMCELL private label products’ marketing strategy, sales and marketing plans whilst staying abreast of current and new markets. • Contributed to private label products’ strategies by reviewing the existing product performance, analyzing the efficiency of the marketing and sales process, and by defining the competitive landscape and market position of STEMCELL private label products.

•.Obtained and maintained Marketing Approvals (Product Licenses) in territories administered regional office •Project managed European (MRP, Centralised, NCE) and World-wide regulatory projects •Prepared registration strategies as appropriate and submitted product license applications •Prepared and submitted either variations of approved product licenses or applications to renew product licenses as necessary

REGULATORY SCIENCE: 

* Life cycle management in particular: - Quality variations 
- Renewals 
- Decentralised procedure - management of national submissions 
- Writing 2.3.P. quality overall summaries 
SCIENTIFIC SERVICES: 

* Scientific writing for regulatory and academic sectors e.g. -
Clarity, readability and English grammar review 
- Scientific feedback prior to, and after submission to peer-reviewed journals 
- Translation of regulatory and scientific documents and websites (German or English)

* Life cycle management in particular: - Quality/CMC variations - specifically conversion of NTA Part II dossiers into eCTD format - Renewals 
 - Decentralised procedure - management of national submissions 
 - Writing CTD 2.3.P. quality overall summaries 
 - Clarity, readability and English grammar review 
 
 - Translation of regulatory and scientific documents (German or English)

*Keeping abreast of international legislation, guidelines and customer practices *Collecting and collating a wide range of information for submission for MRP/DCP and of licence variations and renewals *Monitoring timelines for procedures, licence variations and renewal approvals to strict deadlines in cooperation with the project management team *Liaising, negotiating and communicating with regulatory authorities and clients

* Further enhancement on technical skills learnt during my PhD. * Technical expertise in: - Fluorescence and Absorbance Spectroscopy - Fluorescence Microscopy (confocal and TIRF) - Kinetic characterisation - Cell biology methodologies including: maintaining cell cultures, cell transfection, immunofluorescence and western blotting * Experimental design * Data analysis using various software packages * Publication in a peer-reviewed journal * Supervision of project students

Gained invaluable experience in data analysis/interpretation, literature searching and report writing. Adept and competent at experimental design and working efficiently and effectively to tight deadlines. The quality and quantity of science led to publication of a number of peer-reviewed papers.

Core modules in Biochemistry and Chemistry. Covering core chemical synthesis, mechanism and analysis; pharmacology, physiology and core cancer modules.