Senior Regulatory Consultant CMC Small Molecules
SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
Our client is a professional Biotechnology and Pharmaceutical organization, based in Waadt Switzerland.
Our client is a multinational Pharma company in Switzerland
Lead and set the Chemistry, Manufacturing and Control (CMC) regulatory plan and strategy pertaining IMPN
Responsible for all CMC regulatory activities including
- Coordinating regulatory documentation writing of all quality sections for assigned submissions worldwide.
Serving as the CMC Regulatory Affairs strategy contact point for different teams within Regulatory Affairs, Technical Ops and other.
- Act as GRA contact point for CMC regulatory strategy for NCE products
- Lead or support regional Health Authority interactions and negotiations
- Ensure that the input in development projects incorporates the outcome of consultations with regulatory authorities,
- Ensure understanding of the regulatory competitive and intelligence environment to adapt the CMC regulatory strategy accordingly
- Ensure aligned regulatory input into CMC development decision making
- Develop and drive the execution of regional CMC regulatory strategies to meet Health Authority expectations
- Experience of direct interactions with Health Authorities
- In-depth knowledge of global pharmaceutical legislation
- English business fluent
- Degree in a Life Science or related discipline (minimum MSc or equivalent degree)
- Experience with life-cycle management activities in at least two regions (e.g. Europe, USA, International would be an asset)
- Knowledge and practical experience with NCEs including QbD
- Knowledge of clinical trial development phases, IND/IMPD requirements
- Minimum of 10 years of pharmaceutical industry experience, with at least 5 years of global CMC regulatory experience
- Practical experience in one of the following area for small molecules: manufacturing process development, transfers, validation or analytical development and -quality management
- Project Management
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Daniel Woudenberg.