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

Job Description

Organon is a Women’s Health Company that believes in a better and healthier every day 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 every day. 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.  Primary responsibilities include, but are not limited to:

Although one or more potential candidates for this position have been identified, we will consider applications from any interested applicants."

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/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, technical and regulatory information within CMC submissions, responses and correspondence.

Identify, communicate, and escalate potential regulatory issues to Organon Regulatory CMC management, as needed

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

Direct experience in Regulatory CMC is preferred with preference for experience in Combination Products.

The candidate must be proficient in English; additional language skills are a plus.

Proven experience in critically reviewing detailed scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.

Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner.  Strong listening skills.

Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.

Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.

Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.

Demonstrated effective leadership, communication, interpersonal and negotiating skills.

Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines.

Preferred Experience and Skills

A candidate with experience in Regulatory CMC with demonstrated understanding of related pharmaceutical, biological or device operations (e.g., manufacturing, process development, analytical, and quality assurance) is preferred.

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 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.

US and PR Residents Only

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

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.

Search Firm Representatives Please Read Carefully 

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)

$125,400.00 - $213,100.00

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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

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

10%

Flexible Work Arrangements:

Flex Time, Hybrid, Remote Work

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1