Regulatory Affairs Scientist with Expertise in Chemistry and Manufacturing
Há 3 dias
**Job Summary:**
We are seeking an experienced Regulatory Affairs Scientist to join our team at Organon. This role is responsible for facilitating and implementing regulatory CMC strategies for assigned small molecule products supporting site of source changes in accordance with global regulations and guidance.
Key Responsibilities:
- Work closely with the CMC Product Lead to ensure delivery of all regulatory milestones for assigned projects.
- Provide input to global product and project regulatory strategies by assessing CMC changes, identifying global regulatory requirements, and critically evaluating supporting documentation.
- Lead the development and execution of global product and project regulatory strategies by ensuring robust assessment of CMC changes, identification of global regulatory requirements, and critical evaluation of supporting documentation.
- Collaborate with manufacturing and supply colleagues to support compliant execution of change management.
- Manage execution of CMC documentation, including post-approval supplements and responses to health authority questions.
Requirements:
- Bachelor's degree in a science, engineering, or related field (e.g., pharmacy, chemical engineering, biology) with at least 7 years of relevant experience, or advanced degree with at least 4 years of experience.
- Strong negotiation, interpersonal, written, and oral communication skills.
- Ability to lead by influence and work effectively in matrix organizational structures.
- Project management experience and good understanding of change management projects.
About the Role:
This role offers a competitive salary of $120,000 - $160,000 per year, depending on experience, plus additional benefits and opportunities for growth and development.
Why Join Us:
At Organon, we value innovation, collaboration, and excellence. We offer a dynamic and supportive work environment that fosters professional growth and development. Our team members enjoy a range of benefits, including comprehensive health insurance, retirement plans, and paid time off.
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