Michelle Ravert

About Michelle Ravert

RAC (US) certified scientific processional with over 15 years cGMP experience and knowledge in both the pharmaceutical and medical device industry. Obtained a Master’s of Science (MS) degree in Biotechnology with a Regulatory Affairs concentration from The Johns Hopkins University.

Experience

1. Regulatory Affairs Manager

   Alcon

   Jan 2023 — Present · Lake Forest, CA, US

   Directing submission development of product registration, progress reports, supplements, amendments, and/or periodic experience reports• Providing strategic product direction to teams on interaction and negotiating evidence with regulatory agencies• Interacting and negotiating with regulatory agency personnel in order to expedite approval of pending registration and answer any questions• Serving as a regulatory liaison on the project team throughout the product lifecycle• Participating in one or all of the following activities: development of product plan, regulatory strategy, risk management, implementation plan, chemistry manufacturing control (CMC)• Ensuring pre-clinical and clinical trial designs meet regulatory requirements• Ensuring rapid and timely approval of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices• Serving as regulatory representative to marketing or research project teams and government regulatory agencies• Providing advice to development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations• Coordinating, reviewing and potentially preparing reports for submission In some organizations, may coordinate and maintain reporting schedules for new drugs, medical devices, and biologic/biotechnology and marketed products notices.

Education

• The Johns Hopkins University

  Masters of Science, Biotechnology (Regulatory Affairs)

  2009 — 2014

• Penn State University

  Bachelors of Science, Biotechnology

  2002 — 2006

Skills

• Vaccines
• Cell Culture
• Rac
• Gmp
• Complaint Handling
• Pharmaceutical Industry
• Sop
• Fda
• Downstream Processing
• Monoclonal Antibodies
• Recalls
• Life Sciences
• Regulatory Affairs
• Lifesciences
• Purification
• Microbiology
• Drug Discovery
• Regulatory Affairs Certification
• Validation
• Quality System
• Glp
• Quality Assurance
• 21 Cfr Part 803
• Biotechnology
• Medical Devices
• Capa
• Field Actions
• Rac
• U.s. Food and Drug Administration (Fda)
• 21 Cfr Part 11
• Lims
• Aseptic Processing
• Hplc
• Biopharmaceuticals
• Chromatography
• Medical Device Regulation
• Technology Transfer