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CMC Regulatory Intelligence Specialist
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 BioPharmaceutical company specialized in Monoclonal Antibodies and Biosimilars.
To support the CMC Regulatory & Pharmaceutical Science intelligence (CMC R&PS) Process and be responsible and accountable for driving all related activities, which consists in analyzing, interpreting, communicating and acting on intelligence relative to the CMC landscape, to drive current or future compliance.
Regulatory intelligence and knowledge management
- Serve as internal CMC regulatory main contact point to respond on ad-hoc basis of requests from GRASP or other proponents (e.g representatives of trade associations)
- Manage, monitor supportive CMC intelligence activities (data base update, triage etc...), track progress of related actions till completion (review/comments, impact assessment, communication etc.), proposed SuMEs (subject matter expert) when necessary.
- Analyze targeted information and data from multiple sources (i.e. GRASP, industry association representatives), conduct an insightful Impact Assessment as needed, generate a meaningful output and share knowledge across the CMC community for further implementation within the quality/regulatory documentation system.
- Perform a specific CMC surveillance by collecting questions from Heath Auth. during clinical development and Life cycle management of products, in order to adapt the CMC strategy accordingly in projects/products.
- Coordinate and consolidate comments and/or perform reviews of guidelines, ensuring alignment on position between all affected functions before further communication to GRASP or Association representatives
- Establish, maintain, ensure and enhance knowledge expertise of regulatory environment within Quality/CMC area by:
o Developing and setting up appropriate tools and system
o Providing training to the CMC community (Sites, REG CMC)
o Developing general and/or specific regulatory and procedural guidances (Authors Guide, templates)
o Maintaining up to date and improving the CMC expert network
- Develop and maintain indirect (via MS representative) or direct relationships with external trade associations (e.g EBE or EFPIA working group etc),
- May Represent in industry / professional associations /congresses influencing the development of the regulatory environment
Interface in a matrix environment
- Representing CMC Regulatory Affairs in teams such as QRIC (Quality Regulatory Information Committee),
- Train Regulatory CMC professionals
- Lead commenting and interpretation through Regulatory CMC intelligence Sub-teams,
- Assist CMC Regulatory Managers/specialists in the development of CMC regulatory strategy for complex submissions of Products
- Support initiatives to map and improve processes and systems (including development and review of SOPs)
- May prepare Quality Sections which form the basis of worldwide submissions such as : IND/IMPDs, Briefing Books, applications for variations/NDAs, line extensions and renewals in close cooperation with quality units and GRA
- Degree in a Life Science or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)
- Minimum of 10 years of pharmaceutical industry experience, with at least 5 years of global CMC regulatory experience
- Knowledge of clinical trial development phases, IND/IMPD requirements and Experience with life-cycle management activities in at least two regions (e.g. Europe, USA)
- Ability to develop and prepare successful regulatory strategies for dossier submissions
- Experience of direct interactions with Health Agencies
- In-depth knowledge of global pharmaceutical regulations, guidelines and Pharmacopoeia (at least Ph.Eur. and USP)
- Previous experience in regulatory intelligence, or as Health Agency member
- Excellent written and spoken communication skills in English (knowledge of other European languages is an asset such as German or French)
- Attention to details
- Ability to think strategically and critically analyze complex and/or ambiguous information an assess impact on products and process
- Ability to effectively communicate and summarize complex issues verbally and in writing
- Ability to work in teams and also to work independently and focus on multiple issues / deadlines simultaneously
- Project management
- Business orientation
- Good organizational and planning skills
- Experience working within a global team framework and a multi-cultural environment and lead in a matrix environment
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.