Associate Director, Biologics Regulatory Chemistry, Manufacturing and Control
Company: Careerbuilder-US
Location: Arlington
Posted on: January 18, 2023
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Job Description:
Job DescriptionOrganon 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 team of one to two 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 include, but are
not limited to: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.Education Minimum Requirements:Bachelor's degree, in a
science, engineering,---or a related scientific field.------ Fields
of study include---Chemistry, Biochemistry, Chemical
Engineering,---Biology, Pharmacy, Microbiology, Virology, or
Molecular Biology---with at least 7 years of relevant experience
including biological research, manufacturing,---quality,---or a
related field.OR --- ---Advanced degree (MS, MBA, Ph.D., PharmD)
with at least 4 years of relevant experience including biological
research, manufacturing, quality, or a related field.---Required
Experience and Skills:At least four (4) years of relevant
regulatory CMC experience, including biological research,
manufacturing, analytical testing, quality, or related fields.The
candidate must be proficient in English; additional language skills
are a plus.Technical Skills: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.Technical writing experience for regulatory
CMC submissions including, new biologics license application
BLA/marketing authorization application (MAA), IND/CTA,
post-approval variations, and health authority queries.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 guidances.Leadership Skills: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.Managing
multiple projects to ensure on-time deliverables and timely
submissions to ensure product supply continuity.Preferred
Experience and Skills:Direct experience in Regulatory CMC
Biologics.Global CMC strategies for the development and
registration of biological products.Device and/or combination
product regulatory experience.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.comUS and PR Residents OnlyIf 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 PosterEEOC GINA SupplementOFCCP EEO
SupplementOFCCP Pay Transparency RuleOrganon is an equal
opportunity employer, Minority/Female/Disability/Veteran - proudly
embracing diversity in all of its manifestations.Search Firm
Representatives Please Read CarefullyOrganon 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:RegularRelocation:No relocationVISA
Sponsorship:NoTravel Requirements:10%Flexible Work
Arrangements:Remote WorkShift:1st - DayValid Driving
License:NoHazardous Material(s):Number of Openings:1Requisition ID:
R507054This employer is a corporate member ofmyGwork - LGBTQ+
professionals, the business community for LGBTQ+
professionals,students, inclusive employers & anyone who believes
in workplace equality.
Keywords: Careerbuilder-US, Arlington , Associate Director, Biologics Regulatory Chemistry, Manufacturing and Control, Executive , Arlington, Virginia
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