Senior Regulatory Chemistry Expert
Há 17 horas
Organon is a leading global healthcare company focused on delivering innovative health solutions for women and their families.
About the RoleWe are seeking an experienced Senior Scientist to join our Regulatory Affairs team as a Senior Regulatory Chemistry Expert. This role will be responsible for implementing regulatory strategies for assigned products, ensuring compliance with global regulations and guidelines.
Key Responsibilities- Provide input to global product and project regulatory strategies by assessing CMC changes, identifying global regulatory requirements, and evaluating supporting documentation.
- Lead the development, authoring, and review of CMC submission components and documentation to support post-approval supplements and responses to health authority questions.
- Maintain timely and accurate CMC submissions in systems, ensuring product compliance.
- Liaise with manufacturing and supply colleagues and external partners to support compliant execution of change management.
- Assess and communicate potential regulatory risks and propose mitigation strategies.
To succeed in this role, you will require:
- A Bachelor's degree in a science, engineering, or related field, or an Advanced degree in a relevant field.
- At least four years of overall relevant work experience, or two years with an Advanced degree.
- Minimum of two years of relevant CMC experience, including biological/pharmaceutical research; manufacturing, testing, or a related field.
- Proficiency in English; additional language skills are a plus.
Demonstrated experience in regulatory CMC and/or authoring of regulatory documentation, device and/or combination product regulatory experience.
BenefitsAs a valued member of our team, you can expect:
- An annualized salary range of $120,000 - $180,000 (Global), and $130,000 - $200,000 (Canada).
- Flex time shift.
- No relocation required.
- No VISA sponsorship.
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