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

Job Description

The Position

The Principal Scientist (Director) Regulatory CMC is responsible for Regulatory Chemistry Manufacturing & 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

• Bachelors Degree, in a science, engineering,or a related field. Fields of study includePharmacy, Chemistry, Chemical Engineering,Biology,Microbiology, Virology, Molecular Biology, or Biochemistrywith at least 10 years of relevant experience including biological/pharmaceutical/device research, manufacturing,testingor a related field OR

• Advanced degree (MS, MBA, Ph.D., PharmD) with at least 5 years of relevant experience including biological/pharmaceutical/device research, manufacturing,testingor a related field

• Minimum 10 years pharmaceutical or related industry experience; 5 years with an advanced degree. Minimum 5 years working in Regulatory CMC, with progressive experience in leading global development-phase programs.

Preferred Experience and Skills

The ideal candidate will have strong experience in Regulatory CMC with strong leadership skills, as well as demonstrated understanding of related pharmaceutical and/or biological development (e.g., manufacturing, process development, analytical, and quality assurance). The candidate must demonstrate the ability to develop creative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities or unexpected events. He/she must have a depth of experience in defining global regulatory CMC strategies, superb collaboration skills, rapid, disciplined decision making and critical thinking capabilities, and work well under pressure to be successful in this role. The candidate must have excellent interpersonal, verbal and written communication, presentation, and listening skills. He/she must have proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data. The candidate must be proficient in English; additional language skills are a plus.

OCMC

Secondary Language(s) Job Description

Who We Are:

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 Womens 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.

US and PR Residents Only

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Organon is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, veteran status, or any other characteristic protected by state or federal law.

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Organon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Applicable to United States Positions Only: Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Annualized Salary Range (US)

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID: R534936