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Organon & Co. Associate Director, Regulatory Affairs CMC - Global Network Project & Resource Management in Philadelphia, Pennsylvania

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!

The Associate Director (Associate Principal Scientist), Organon, Manufacturing & Supply (OMS), Chemistry, Manufacturing & Controls (CMC), Network Project & Resource Management will provide regulatory CMC support, for Organon Network projects. This position will lead the preparation, and submission of CMC dossiers for assigned Network Projects. The individual may also support project team goals and organizational initiatives, on an as needed basis. This will include oversight and monitoring of assigned CMC project timelines. This position will work alongside CMC Product Leaders, OMS Network Teams and CMC partners and ensure progress to achieve project goals. The position will also be responsible for providing CMC support to the Network Project CMC Lead for making strategy for projects.

This position will also be responsible for working with outsourced support of Network activities in alignment with the OMS CMC outsource strategy. This includes proactive collaboration with external partners to monitor, report and act on delivery performance and quality of deliverables. The incumbent requires in-depth knowledge and skills in CMC strategy, with strong capability in project management. The successful candidate requires a strong track record of demonstrated knowledge of CMC life cycle management and eCTD.

Primary Responsibilities:

  • Managing processes and connections between the external partners and the various stakeholders within CMC and OMS

  • Serve as the CMC Lead for assigned Global Network projects and be accountable for the delivery of all regulatory milestones

  • Responsible for overseeing preparation, and submission of Global CMC dossiers for assigned Network projects

  • Cultivate and foster collaborative relationships with internal and external partners to drive on-time, high quality delivery of business commitments

  • Actively monitor, facilitate, report, and communicate progress against agreed timelines and proactively resolve issues to enable delivery of high-quality, on-time submission information

  • Escalate potential delays or performance issues in a timely manner to impacted, cross-functional stakeholders

  • Manage communication and change management within the internal organization

  • Provide CMC support for Legal Entity Change (LEC) project

Education Minimum Requirements:

  • Bachelor’s Degree, in a science, engineering, or a related field.   Fields of study include Pharmacy, 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 4 years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field

  • Direct experience in Regulatory CMC is preferred

Required Experience and Skills:

  • Strong negotiation, interpersonal, written/oral communication and fluent in English language

  • Ability to lead by influence and work effectively in matrix organizational structures

  • Project Management experience

  • Good understanding of change management projects

Preferred Experience and Skills:

  • Demonstrated experience driving change initiative projects

  • Degree in pharmacy, biopharmaceutics, analytical chemistry, organic chemistry, chemical engineering, or a related discipline

  • Demonstrated experience driving change initiative projects

  • Degree in pharmacy, biopharmaceutics, analytical chemistry, organic chemistry, chemical engineering, or a related discipline

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.

Subject to applicable law, all prospective US Organon hires will be required to demonstrate that they have been fully vaccinated against COVID-19 with a vaccine authorized or approved by the Food and Drug Administration (FDA), or qualify for a medical or religious accommodation to this vaccination requirement, as a precondition of employment.

Residents of Colorado: to request this role’s pay range: email: coloradopayact@organon.com

Jersey City and New York City Positions: to request this role’s pay range and benefits, email: jcnycpayact@organon.com

US and PR Residents Only

If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com .

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, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.

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.

Employee Status:



No relocation

VISA Sponsorship:


Travel Requirements:


Flexible Work Arrangements:

Flex Time, Telecommuting


Valid Driving License:

Hazardous Material(s):

Number of Openings:


Requisition ID: R510675