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Director, Biologics Regulatory Chemistry, Manufacturing and Control

Company: Organon & Co
Location: Vineland
Posted on: November 22, 2022

Job Description:

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 Executive Director in Regulatory Chemistry, Manufacturing and Control (CMC), the candidate is responsible for developing and implementing Regulatory CMC strategies for assigned biological products in accordance with global regulations, guidance, and our Company's procedures. The candidate will lead the preparation and submission of CMC dossiers for original registrations, life-cycle maintenance submissions, and post-approval changes. The candidate may manage a small group of individual contributors and/or outsourcing partners in support of project execution. The candidate may also support project team goals and organizational initiatives on an as needed basis.

Primary Responsibilities:

* Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through initial product registration and launch, and across the product's lifecycle.

* Lead the development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.

* Execute regulatory strategies by leading the development, authoring, and review of CMC submission components and documentation to support investigational new drug (IND)/clinical trial application (CTA) submissions, post-approval supplements, annual reports, registration renewals, and responses to health authority questions per established business processes and systems.

* Interact with relevant Health Authorities to support submissions, response to questions, and agency meetings.

* Identify, communicate, and escalate potential regulatory issues to our Company's Regulatory CMC management, and propose mitigation strategies, as needed.

* Collaborate with our Company's Manufacturing & Supply colleagues and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.

* Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and product supply continuity.

* Provide regulatory leadership as needed to product in-license/due diligence review, product divestment, and product withdrawal.

* May manage a small number of individual contributors or outsourced staff who are responsible for their products/projects.

Education Minimum Requirement:

* Bachelor's Degree in a science, engineering,or a related scientific field. Fields of study includeChemistry, Biochemistry, Chemical Engineering,Biology, Pharmacy, Microbiology, Virology, or Molecular Biology with at least 10 years of relevant experience including biological research, manufacturing, quality or related field.

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

Required Experience and Skills:

* At least five (5) years of relevant regulatory CMC experience, including biological research, manufacturing, analytical testing, quality, or related fields.

* Technical writing experience for regulatory CMC submissions compliant with current CTD requirements including, new biologics license application BLA/marketing authorization application (MAA), IND/CTA, post-approval variations, Agency meeting briefing packages, and health authority queries.

* Proficient in relevant ICH guidelines and registration requirements.

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

* Develop CMC regulatory strategy to advance product development with track record of biologics product registration in major markets.

* Evaluation of subject matter expert (SME) technical documentation for completeness and sufficient details in order to make accurate regulatory assessments through utilization of current global regulatory guidelines.

* 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.

* Ability to lead communications with regulatory agencies to facilitate review and approval of submissions.

* Demonstrated ability to generateinnovative 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.

* Managing multiple projects to ensure on-time deliverables and timely submissions to ensure product supply continuity.

Preferred Experience and Skills:

* Strong experience in developing global regulatory strategies for biological products.

* Strong technical leadership skills, as well as demonstrated understanding of related biological operations (e.g., biologics manufacturing and quality).

* Device and/or combination product regulatory.

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:

Jersey City and New York City Positions: to request this role's pay range and benefits, email:

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

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.

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Keywords: Organon & Co, Vineland , Director, Biologics Regulatory Chemistry, Manufacturing and Control, Executive , Vineland, New Jersey

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