Associate Principal Scientist, Regulatory Affairs Chemistry Manufacturing
1 semana atrás
Job Description
The Position
The Associate Principal Scientist, Regulatory Affairs Chemistry Manufacturing will provide regulatory support to ensure compliance with global regulations and standards. This includes preparing and submitting regulatory documents for assigned projects. The individual will lead the preparation of CMC dossiers and work alongside cross-functional teams to ensure timely delivery of regulatory milestones.
Key Responsibilities
- Lead the preparation and submission of CMC dossiers for assigned projects.
- Provide regulatory support to ensure compliance with global regulations and standards.
- Work alongside cross-functional teams to ensure timely delivery of regulatory milestones.
- Cultivate and foster collaborative relationships with internal and external partners to drive on-time delivery of business commitments.
- Actively monitor, facilitate, report, and communicate progress against agreed timelines and proactively resolve issues to enable delivery of high-quality regulatory documentation.
Requirements
- Bachelor's degree in a science, engineering, or a related field.
- Or advanced degree (MS, MBA, Ph.D., PharmD) - minimum 4 years of relevant experience.
- Strong negotiation, interpersonal, written/oral communication and fluency in English language.
- Ability to lead by influence and work effectively in matrix organizational structures.
- Project Management.
- Good understanding of change management projects.
About Organon
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. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
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