Freelance CMC RA Manager
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 Pharmaceutical organization, based in Noord-Holland Netherlands.
Our valued client values solving complex medical challenges and takes more than hard work and dedication; they achieve this though a unique combination of skills and strengths.
Seeking a Freelance, Regulatory Affairs CMC, who enjoys a fast paced, dynamic work environment. The individual has departmental and corporate level influence in order to plan, evaluate and recommend CMC regulatory strategy. Externally, the individual will interface with outside regulatory agencies and business partners in regards to CMC development, regulatory, and registration strategies. He/she will support/lead development and implementation of department policies. The individual will also maintain awareness of global regulatory environment and assess and communicate impact of changes on business and product development programs.
• Provides strategic and operational regulatory direction and mentorship on projects including, but not limited to general CMC regulatory strategies, regulatory requirements for clinical studies
• Uses extensive knowledge of NL and EU regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects
• Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise
• Able to articulate complex Regulatory CMC issues and support global development and commercialisation of early and late state programs
• Oversees and/or leads as necessary the preparation and submission of documentation to support investigational and marketing registration packages throughout Europe and ensures timelines are met
• Maintains awareness of European regulatory environment and assesses impact of changes on business and product development programs.
• Develops and implements department policies, processes and SOPs
BA/BS Degree required, preferably in a health/life sciences or related field
A minimum of 15 years in the biotechnology or pharmaceutical industry. Extensive experience in CMC Regulatory, lifecycle management, interactions with Health Authorities, leading and managing regulatory teams, and developing and implementing complex CMC regulatory strategies
Strong understanding of and experience with global medical device-drug combination regulatory approvals;
Rare disease experience is desirable
Business travel to be ~10-20% as required