Simon Williams Email & Phone Number

Basildon, Gb

Harlow

Responsible for EU Biosimilars within the global Biosimilars function.

Harlow

Management of a small team responsible for submission of new MAAs and for post-approval maintenance. New MAA submission include CP and DCP procedures for oral (solid dose) and parenteral dosage forms, launch critical and technical variations and product information updates. Involvement in setting regulatory strategy for a range of projects including Teva’s NTE and complex sterile product streams as well as scientific advice and referral procedures.

Working in both the Hospitals and High Priority groups, utilising regulatory experience together with background in parenteral product manufacture and development. Responsibilities include running CP and DCP procedures for Oral and Parenteral dosage forms, launch critical and technical variations and involvement in scientific advice and referral procedures.March-June 2013: spent 3 months working with the Teva USA regulatory team at Woodcliff Lake NJ. Duties included reviewing the quality sections for new ANDA and 505(b) submissions.

Promoted into a supervisory role, taking on the responsibility for a small team of regulatory affairs professionals. Additional duties include arranging work-loads, scheduling submissions and training new employees.

Moved from the laboratory into regulatory affairs after 7 years, looking for a fresh challenge. Duties included preparing dossiers for new MA applications, responding to RFIs and running national, decentralised and mutual recognition procedures. Additional duties include preparation and submission of variations and PSURs.

Returned to Martindale Pharmaceuticals to join the New Product Development team. Duties included stability testing, method development and validation, formulation studies of parenteral products and oral solutions. Involved in problem solving teams solving issues with manufacturing and stability.

Swindon, United Kingdom

Duties included the analysis of finished products for stability trials. Carried out full method validation and cleaning validation, and wrote the resultant reports.

Duties included the analysis of finished products, raw materials and packaging components for a pharmaceutical manufacture. Analytical techniques used include: HPLC, GC, FTIR as well as classic “wet chemistry” techniques. Trained new starters and wrote SOPs for new instruments.

Bachelor Of Science (Bsc), Chemistry

Education record