Join the renowned Patent Litigation team contributing to complex patent disputes. Involve in the life sciences and high - tech sectors with flexible working arrangements.
SI
Hybrid Associate Principal Scientist, Regulatory Affairs, Chemistry Manufacturing & Controls
Posted 2 months ago
About the role
- Associate Principal Scientist leading Regulatory CMC strategies for small molecule and biological products. Ensuring compliance with global regulations while driving product lifecycles in pharmaceutical industry.
Responsibilities
- Develop and implement Regulatory Chemistry, Manufacturing & Controls strategies
- Serve as the CMC Product Lead or support the CMC Product Lead for assigned projects
- Lead development and execution of global product and project regulatory strategy
- Execute regulatory strategies by leading the development, authoring and review of CMC submission components
- Provide regulatory leadership as needed to product in-license/due diligence review
- Collaborate with Organon Manufacturing & Supply colleagues and external partners
Requirements
- Bachelor’s Degree in science, engineering, or related field
- At least 7 years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field OR Advanced degree with at least 4 years of relevant experience
- At least four (4) years of relevant experience
- Proficient in English; additional language skills are a plus
- Proven experience in critically reviewing scientific information
- Demonstrated superior oral and written communication skills
- Strong listening skills
- Demonstrated sound understanding of related fields
Benefits
- retirement savings plan
- paid vacation and holiday time
- paid caregiver/parental and medical leave
- health benefits including medical, prescription drug, dental, and vision coverage
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Research Scientist developing generative AI technology at Snap Inc. Leading research agenda and partnering with engineering teams to innovate for millions of users.
Senior Researcher informing product design and strategy at Salesforce. Focused on data - driven insights for field service management.
Principal Scientist overseeing liquid innovation at Suntory Global Spirits. Leading development projects in Shanghai with cross - functional teams for product enhancement.
Senior AI/ML Research Scientist developing ML models for adjoe's innovative advertising solutions. Engaging in research and collaboration to enhance business - driven projects.
Referendar und wissenschaftlicher Mitarbeiter bei Bird & Bird in Hamburg, Fokus auf neue Technologien und Wirtschaftsrecht. Unterstützung in der Mandatsarbeit und Examensvorbereitung für Absolventen.
Referendar und wissenschaftlicher Mitarbeiter for Bird & Bird, advising technology - focused industries. Engaging in economic and corporate law with flexible work arrangements.
Research Assistant supporting clinical research team focused on advancing stroke care. Responsibilities include data collection, analysis, and regulatory compliance in clinical settings.
Research Assistant performing lab duties in a Maternal Fetal Medicine lab. Responsible for experiments, maintenance, and training within the research team.
Principal Scientist at Johnson & Johnson enhancing ORBIT platform by leading requirements and cross - functional team collaboration. Fostering innovative medicine through data analytics and computational sciences.