Director, Biologics Regulatory Chemistry, Manufacturing and Control
Company: Organon & Co
Posted on: November 22, 2022
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.
* 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
* 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
* 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
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
* 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
* 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
* 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
* 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
* 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
* 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
* 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: email@example.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
For more information about personal rights under Equal Employment
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.
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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.
Flexible Work Arrangements:
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Keywords: Organon & Co, Vineland , Director, Biologics Regulatory Chemistry, Manufacturing and Control, Executive , Vineland, New Jersey
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