Associate Director, Regulatory Affairs CMC - Global Network Project & Resource Management - HYBRID

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 (WHO), 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 WHO

• Serves 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 resolves 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 - Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology

• Or Biochemistry  - minimum 7 years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field

• Or advanced degree (MS, MBA, Ph.D., PharmD) - minimum 4 years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field

• Preferred- degree in pharmacy, biopharmaceutics, analytical chemistry, organic chemistry, chemical engineering, or a related discipline

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

• Good understanding of change management projects

Preferred Experience and Skills:

• Direct experience in Regulatory CMC

• Demonstrated experience driving change initiative projects

OCMC

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

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:

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Organon proudly embraces diversity in all of its manifestations and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants 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.

Salary Range

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:R516683