Principal Scientist, Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC) - HYBRID

Job Description

The Position

The Principal Scientist (Director) Regulatory Chemistry, Manufacturing and Controls is responsible for Regulatory Chemistry Manufacturing and Controls (CMC) aspects of projects in clinical phase through initial product registration and post approval life cycle management for the assigned portfolio of small molecule or biologic products. The Principal Scientist may also support project team goals and organizational initiatives, on an as needed basis. The incumbent may manage a team of 1 to 2 individual contributors and/or outsourcing partners in support of project execution. The position is a fast-paced, dynamic, and impactful leadership role with direct ability to impact Organon future growth strategy & pipeline development.

Responsibilities

• 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. This includes documenting regulatory CMC strategies, preparation of applicable IND/CTAs, Health Authority Regulatory CMC engagement strategy, Agency Background Packages, leading or 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.

• Enable implementation 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, understanding the impact to the business, utilizing regulatory intelligence, and incorporating knowledge of the changing regulatory environment.

• Embed regulatory CMC activities within product development plans that outline the requirements for the product, the development plan and associated regulatory approval timeline and how this will be managed, the key risks and tradeoff decisions that are required.

• Responsible to ensure that 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, technical and regulatory information within CMC submissions, responses and correspondence.

• Proactively identifies and solves complex problems or key business challenges within the Portfolio that may have significant impact to the company and identifying solutions that may require innovative approaches to achieve a solution.

• Demonstrated ability to anticipate and influence within and across organizations and the regulatory environment to identify potential challenges impacting the business and proactively recommend approaches to minimize regulatory risk.

• Demonstrated ability to be highly adaptable and establish strong cross-functional relationships with key stakeholders, customers and external organizations to ensure regulatory CMC strategies are incorporated into a broad enterprise view. Represents Regulatory CMC on cross-functional teams.

Required Education, Experience and Skills

• Bachelor’s degree, in a science, engineering, or a related field. Fields of study include Pharmacy, Chemistry, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry with at least ten years of relevant experience including biological/pharmaceutical/device research, manufacturing, testing or a related field OR Advanced degree (MS, MBA, Ph.D., PharmD) with at least five years of relevant experience including biological/pharmaceutical/device research, manufacturing, testing or a related field.

• Minimum ten years pharmaceutical or related industry experience or five years with an advanced degree.

• Minimum five years working in Regulatory CMC, with progressive experience in leading glob