Miloš Repše

• Regulatory CMC Project lead for a designated product/project
• Formulate, lead and drive global CMC regulatory strategy and all global CMC submission activities ) for assigned projects
• Coordinate and communicate CMC regulatory strategies, risks and key issues with project teams and other stakeholders
• Initiate and lead Health Authority interactions and negotiations; preparing briefing books

Accomplishments:

• As RPL for GP17/GPN017 I coordinated the CMC regulatory team of 9 Managers
• Responsible for US/EU approval of HCF, successful roll out to other highly regulated markets HRMs (UK, AU, CH....) and for the roll out globally.
• Tackled the variation backlog on LCF to prevent supply shortage on the market

• Support DD lead in coordinating and leading 2 Due Diligence projects including supporting scientific discussions, organizing sub-workstreams, leading interactions with the team and external partner, helping with preparation of the meeting materials
• Support DD lead with early assessments of DD opportunities
• Involved in OpEx initiatives, including preparation of working templates and creating training materials

• Head of Sandoz Small molecule RA CMC department
• Leading, directing and motivating the team
• Implementation and follow-up of development plans
• Supporting Development Center on execution of new allocated products and strategic projects
• Coaching and training of the DRC staff with respect to global regulatory requirements and key competencies
• Establishing efficient team organization and working methods in accordance with internal Sandoz guidelines and standards
• Providing best in class regulatory input to relevant stakeholders for decisions making

Accomplishments:

• Responsible for building up the team of 10 CMC managers, with the focus on the Sandoz values
• Active role in the transformation - Successful migration of the projects from the closing development sites
• Responsible for around 7 major (US/CA/EU) new submissions per year

• Group Head of Sandoz Small molecule RA CMC department
• Lead a team of 10+ employees including target setting, control of efficiency, motivation and coaching of the team members
• Functionally lead registration team of B2B including contribution to target setting, control of efficiency and motivation and coaching of team members
• General management - organization, capacity planning and decision taking
• Setting of regulatory strategy for new development products, established products and products sold to third parties
• Organize in-time delivery of regulatory strategies and compilation of all registration dossiers (M2 - M5) for new submissions and renewals (US, EU, worldwide)

Accomplishments:

• Several CA/US submissions/approval of mainly legacy anti-infective products
• Introducing efficient team set-up sharing the capacities with the LCM group
• Supporting and guiding team in times of transformation (closing of MRC in Kundl late 2019)

• Regulatory management of all change requests in NTO Anti-Infectives
• First line support of TechOps, QA and project teams on all regulatory questions; secure early alignment on regulatory topics
• Evaluation of multi product, site and product or non-product specific change requests
• Training of other departments on regulatory topics
• Representative of MS&T and DRA in improvement processes at the manufacturing site

Accomplishments:

• Tackled backlog of change requests; strengthen regulatory position within Technical Operations; Author of many lean proposals and solutions

• Preparation and implementation of regulatory strategy for individual product in EU
• Leading new MRP/DCP/CP procedures
• Communication with national authorities, EMA
• Submission of PIP waivers to EMA
• Preparation of strategy, submission and leading national registrations in France and coordination between HQ and Country Office in France

Accomplishments:

• Successfully led more than 10 DCP/MRP/CP procedures for new generic projects (approx 2 procedures per year).
• Participated in 3 different Scientific advices at DE, FR and HR authority