Sr. Manager, Regulatory Strategy - Oncology
Company: Moderna Therapeutics
Location: Somerville
Posted on: June 24, 2022
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Job Description:
The Role:Moderna Therapeutics is seeking a Manager/Sr. Manager
of Regulatory Strategy based in Cambridge headquarters. This is a
newly created role intended for a forward looking, creative and
agile regulatory manager able to anticipate and address the
challenges involved in gaining market approval for messenger RNA
therapeutics as unprecedented new drug modality. The Manager/Sr.
Manager will provide regulatory support for Oncology. Their support
includes but is not limited to managing the submissions and
approvals of INDs, marketing applications, and other regulatory
submissions (orphan drug designations, pediatric plans, PRIME, BTD
applications, DSURs, MAA/BLA/NDA, etc.)Heres What Youll Do:Develops
and contributes to content, format and accountability for
regulatory submissions and related supplements and amendments,
including FDA meeting requests, briefing books, INDs, CTAs, orphan
drug designations, pediatric plans, PRIME, BTD applications, DSURs,
MAA/BLA/NDA, etc.)Works with RA-Strategist and project teams
regarding the development and execution of regulatory strategy
through the clinical development processes.Responsible for
coordinating aspects of regulatory submissions relevant to assigned
projects or programs.Contact regulatory agencies relevant to
assigned projects or programs, as appropriate.Contribute to the
development and implementation of clinical and pre-clinical
regulatory strategy for projects in all stages of development
(pre-IND/IMPD through commercial).Contribute, maintain the Core
Data Sheet and support global labeling team meetings.Ability to
work both independently and within project teams, committees, etc.
to achieve group goals.Heres What Youll Be Doing:BA/BS degree in a
scientific/engineering/healthcare discipline required, Masters,
PharmD or PhD preferred.5+ years of experience in the
Pharmaceutical industry preferred3+ years of experience in
Regulatory strategy or relevant training/experience
preferredExperience in Oncology is strongly preferredStrong
knowledge of current US and EU regulationsStrong experience with
CTD format and content of regulatory filingsExceptional written and
oral communicationExperience with developing and implementing gap
analysis and related competitive regulatory strategiesKnowledge of
and broad experience with regulatory procedures and legislation for
drug development, product registration, line extension and license
maintenance--preferably from at least both US and EUDemonstrate
strong organizational skills, including the ability to prioritize
workload.Experience and knowledge in the preparation of major
regulatory submissions and supportive amendments or
supplements.Knowledge and understanding of applicable
regulations.Experience in interpretation of regulations,
guidelines, policy statements, etc.Experience working on products
in development specifically relating to clinical and pre-clinical
regulatory aspects of the project.Moderna is pleased to provide you
and your family with a comprehensive and innovative suite of
benefits, including:Highly competitive and inclusive medical,
dental and vision coverage optionsFlexible Spending Accounts for
medical expenses and dependent care expensesLifestyle Spending
Account funds to help you engage in personal enrichment and
self-care activitiesFamily care benefits, including subsidized
back-up care options and on-demand tutoringFree premium access to
fitness, nutrition, and mindfulness classesExclusive preferred
pricing on Peloton fitness equipmentAdoption and family-planning
benefitsDedicated care coordination support for our LGBTQ+
communityGenerous paid time off, including: Vacation, sick time and
holidays Volunteer time to participate within your community
Discretionary winter shut down Paid sabbatical after 5 years; every
3 years thereafterGenerous Paid Leave offerings, including 18 weeks
of 100% paid parental leave for all new parents 401k match and
Financial Planning toolsModerna-paid Life, LTD and STD insurance
coverages, as well as voluntary benefit optionsComplimentary
concierge service including home services research, travel booking,
and entertainment requestsFree parking or subsidized commuter
passesLocation-specific perks and extras! Candidates should be
aware that Moderna currently maintains a policy requiring all
US-based employees to be fully vaccinated against COVID-19 and
receive a booster shot once eligible. Newly hired employees must be
vaccinated and boosted prior to their employment start date.
Moderna is an equal opportunity employer and will provide a
reasonable accommodation to those unable to be vaccinated or
receive a booster where it is not an undue hardship to the company
to do so as provided under federal, state, and local law.About
ModernaIn over 10 years since its inception, Moderna has
transformed from a research-stage company advancing programs in the
field of messenger RNA (mRNA), to an enterprise with a diverse
clinical portfolio of vaccines and therapeutics across seven
modalities, a broad intellectual property portfolio in areas
including mRNA and lipid nanoparticle formulation, and an
integrated manufacturing plant that allows for rapid clinical and
commercial production at scale. Moderna maintains alliances with a
broad range of domestic and overseas government and commercial
collaborators, which has allowed for the pursuit of both
groundbreaking science and rapid scaling of manufacturing. Most
recently, Moderna's capabilities have come together to allow the
authorized use and approval of one of the earliest and most
effective vaccines against the COVID-19 pandemic.Moderna's mRNA
platform builds on continuous advances in basic and applied mRNA
science, delivery technology and manufacturing, and has allowed the
development of therapeutics and vaccines for infectious diseases,
immuno-oncology, rare diseases, cardiovascular diseases and
autoimmune diseases. Moderna has been named a top biopharmaceutical
employer by Science for the past seven years. To learn more, visit
.Moderna is a smoke-free, alcohol-free and drug-free work
environment.Moderna is committed to equal employment opportunity
and non-discrimination for all employees and qualified applicants
without regard to a persons race, color, gender, age, religion,
national origin, ancestry, disability, veteran status, genetic
information, sexual orientation or any characteristic protected
under applicable law. Moderna will make reasonable accommodations
for qualified individuals with known disabilities, in accordance
with applicable law. #LI-JM2-SummaryLocation: Cambridge,
Massachusetts; Clinical DevelopmentType: Full time
Keywords: Moderna Therapeutics, Somerville , Sr. Manager, Regulatory Strategy - Oncology, Executive , Somerville, Massachusetts
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