Lead Regulatory CMC Scientist — Hybrid, Flexible Hours

Organon; Florham Park (NJ); Hybride; USD 125 000 - 213 000; Plein temps

Avantages offerts par ce poste

Hybrid work

Flex time

Résumé du poste

Organon is seeking an Associate Principal Scientist to shape and execute Regulatory Chemistry, Manufacturing & Controls (CMC) strategy for assigned products in the US. You will lead preparation and submission of CMC dossiers, manage a small team or partners, and coordinate with manufacturing to ensure regulatory conformance throughout the product lifecycle.

The role requires strong communication, regulatory expertise, and the ability to drive complex dossiers from development through

Qualifications

• Bachelor’s degree in science or related field with 7+ years of relevant experience.
• Advanced degree (MS, PhD, MBA, PharmD) with 4+ years of relevant experience.
• Proficiency in English; bilingual skills a plus.

Responsabilités

• Lead development and execution of regulatory strategy for CMC.
• Prepare and review CMC submissions and responses.
• Collaborate with manufacturing and external partners to ensure regulatory conformance.
• Mentor junior team members and oversee small teams.
• Ensure regulatory milestones across the product lifecycle.

Connaissances

CMC strategy

Regulatory leadership

Scientific writing

English proficiency

Formation

Bachelor's degree in science/related field

Advanced degree (MS, PhD, etc.)

Description du poste

Organon is seeking an Associate Principal Scientist to shape and execute Regulatory Chemistry, Manufacturing & Controls (CMC) strategy for assigned products in the US. You will lead preparation and submission of CMC dossiers, manage a small team or partners, and coordinate with manufacturing to ensure regulatory conformance throughout the product lifecycle.

The role requires strong communication, regulatory expertise, and the ability to drive complex dossiers from development through