Associate Principal Scientist, Regulatory Affairs Chemistry Manufacturing & Controls (CMC)

Organon is a Women’s Health Company that believes in a better and healthier everyday for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier everyday. But what really makes it work at Organon is our people. We’re looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.

At Organon, you’ll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a fortune 500 company with an international footprint that serves people in more than 140 markets. It’s going to be an exciting future—come be a part of it!

Reporting to the Director in Organon Regulatory CMC, the Associate Principal Scientist (Associate Director) is responsible for Regulatory Chemistry Manufacturing & Controls (CMC) aspects of clinical phase through market product registration for the assigned biological/ biosimilar/medical devices/combination products in accordance with global regulations, guidance's and defined regulatory strategies. These products may be internal or acquired or licensed externally as a key component of the company growth strategy.

The Associate Principal Scientist will be responsible for the preparation and review of information required for development of regulatory CMC dossiers for new product and/or commercial products including original registrations, life-cycle maintenance submissions, and post-approval changes. The organization is envisioned to focus on innnovative products addressing women’s health across diverse therapeutics including Biosimilars and will encompass late-stage development products and commercially approved compouds.

The Associate Principal Scientist may also support project team goals and organizational initiatives, on an as needed basis.

Partner with Research & Development, Manufacturing & Supply, Business Development and Commercial to embed an adaptable process with internal colleagues and Contract Research & Manufacturing Organizations to enable regulatory CMC strategies and execution of clinical study phase and initial product registration activities in an efficient, agile manner. Provide Regulatory CMC and oversight in developing global Regulatory CMC strategies and executing submissions related to diverse late-stage development and/or licensed in products/medical devices/combination products.

This includes documenting regulatory CMC strategies, leading preparation and authorship of applicable IND/CTAs/NDA/BLA and post-approval activities, Health Authority Regulatory CMC engagement strategy, Agency Background Packages, participating in Agency meetings on CMC topics, and executing global initial marketing applications with a line of sight to long-term robust supply. This role will directly support projects and/or coordinate with Regulatory CMC scientists in the Organon franchise teams.

Lead development and execution of regulatory CMC strategies to ensure high quality, accuracy, and high likelihood of approval of all regulatory submissions. This includes assessing CMC changes during development and defining regulatory CMC requirements, demonstrating sound regulatory insight, ensuring a balanced approach to regulatory risk, utilizing regulatory intelligence, and incorporating knowledge of the changing regulatory environment. Embed regulatory CMC activities within product development plans that outlines the requirements for the product, the development plan and associated regulatory approval timeline and how this will be managed.

Support regulatory activities of medical devices in combination with medicinal products. Responsible to ensure regulatory requirements are met and systems/processes are executed in a manner to provide visibility to accurate regulatory information to enable proper product control. Ensures appropriate reviews, approvals and systems are in place to maintain the quality of scientific,…