Regulatory Chemistry Lead
Há 14 horas
We are seeking a highly skilled Regulatory Chemistry Lead to join our team at Organon. This is a critical role that requires expertise in regulatory chemistry, manufacturing, and controls (CMC) strategies.
Key Responsibilities- Global Product Regulatory Strategies: Develop and implement global product regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements, and critically evaluating supporting documentation to assess acceptability and identify potential risks.
- CMC Submission Components: Execute global regulatory strategies by leading the development, authoring, and review of CMC submission components and documentation to support post-approval supplements and responses to health authority questions per established business processes and systems.
- Product Compliance: Ensure product compliance through timely and accurate maintenance of CMC submissions in the systems.
- Liaison with Stakeholders: Liaise with our Company's Manufacturing & Supply colleagues and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
- Education and Experience: Bachelor's degree in a science, engineering, or a related scientific field with at least four years of overall relevant work experience OR Advanced degree (MS, MBA, Ph.D., PharmD) in a science, engineering, or related scientific field with at least two years of overall relevant work experience.
- Certifications and Skills: Minimum of two (2) years of relevant CMC experience, including biological/pharmaceutical research; manufacturing, testing, or a related field. Proficient in English; additional language skills are a plus.
- Leadership Skills: Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families, and the communities they care for.
The estimated salary for this position is $120,000 - $180,000 per year, depending on location and qualifications.
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