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Director, Regulatory CMC
3 weeks ago
Editas Medicine Cambridge, United StatesJob Description · Job DescriptionAt Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harne ...
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Director, Regulatory Affairs Vaccines Cmc
3 weeks ago
ARIAD Boston, United States**Pay Range**: · $169, $266,200.00 · **Job ID** R0120763**Date posted** 04/16/2024**Location** Boston, Massachusetts**Pay Range** $169, $266,200.00**About the role**: · At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transfor ...
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Associate Director, Cmc Regulatory
3 weeks ago
Sarepta Therapeutics Cambridge, United StatesCo-lead the strategy and implementation of global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives. Act as the interface with multiple internal and external stakeholders, including partners. · Works as Global Regulato ...
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Director, Regulatory CMC
1 week ago
Editas Medicine Cambridge, United States Full timeAt Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRI ...
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Manager, Regulatory Affairs CMC
6 days ago
Takeda Development Center Americas, Inc San Francisco, United States PermanentTakeda Development Center Americas, Inc. is seeking a Manager, Regulatory Affairs · CMC in Cambridge, MA to Develop the Global Regulatory Strategy for products in commercial and development phase; ensure timely submission of new submissions (IND, NDA, BLA, JNDA) to various Globa ...
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Manager, Regulatory Affairs CMC
2 weeks ago
Takeda Development Center Americas, Inc Cambridge, United StatesTakeda Development Center Americas, Inc. is seeking a Manager, Regulatory Affairs · CMC in Cambridge, MA to Develop the Global Regulatory Strategy for products in commercial and development phase; ensure timely submission of new submissions (IND, NDA, BLA, JNDA) to various Globa ...
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Director, Regulatory Affairs Vaccines CMC
3 weeks ago
Takeda Boston, United StatesAbout the role: · At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possi ...
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Director, CMC Regulatory Affairs
3 weeks ago
Sarepta Therapeutics Cambridge, United StatesLead the strategy and implementation of global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives. Act as the primary interface with multiple internal and external stakeholders, including partners. Works as Global Regul ...
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Associate Director, CMC Regulatory
3 weeks ago
Sarepta Therapeutics Cambridge, United StatesCo-lead the strategy and implementation of global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives. Act as the interface with multiple internal and external stakeholders, including partners. · Works as Global Regulat ...
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Regulatory Affairs Cmc Officer
3 weeks ago
Cytiva Marlborough, United States**Be part of something altogether life-changing** · Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative ...
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Senior Manager, Regulatory CMC Lead
2 weeks ago
Biogen Cambridge, United StatesJob Description · Job DescriptionJob Description · About This Role · This role is responsible for Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Respon ...
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Manager, Regulatory Affairs CMC
4 weeks ago
Takeda Boston, United States Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Noticeand Terms of Use. I further attest that all information I submit ...
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Director, CMC Regulatory Affairs
3 weeks ago
Alkermes Waltham, United States Full timeOverview: · Great Science. Deep Compassion. Real Impact. · Alkermes is offering exciting opportunities through our commitment to work together to help improve the lives of people living with serious mental illness, and addiction. · We are inspired by the courage and determinatio ...
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Director, CMC Regulatory Affairs
3 weeks ago
Alkermes Watertown, United StatesJob Description · Overview: · Great Science. Deep Compassion. Real Impact. · Alkermes is offering exciting opportunities through our commitment to work together to help improve the lives of people living with serious mental illness, and addiction. · We are inspired by the cour ...
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Associate Director, Regulatory CMC
2 days ago
Intellia Therapeutics Cambridge, United States Full timeWhy Join Intellia? · Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. · Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strong ...
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Senior Director, Regulatory Affairs CMC
4 weeks ago
Alexion Pharmaceuticals Boston, MA, United StatesThis is what you will do:The Senior Director of Regulatory Affairs Chemistry, Manufacturing, and Controls (RA-CMC) will provide strategic as well as operational leadership of global CMC activities related to Cell & Gene Therapy (GCT) leading to successful registration and life-cy ...
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Manager to Sr. Manager, Regulatory CMC
6 days ago
PharmaLex Boston, United StatesJob Description · Job DescriptionPharmaLex[RK1] is one of the largest providers of Development Consulting, Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance, Epidemiology and Risk Management worldwide. Through our US, European and Asian offices, we provide ...
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Associate Director, CMC Regulatory
3 weeks ago
Sarepta Therapeutics Cambridge, United StatesCo-lead the strategy and implementation of global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives. Act as the interface with multiple internal and external stakeholders, including partners. Works as Global Regulatory ...
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Director, Regulatory Affairs Vaccines CMC
3 weeks ago
Takeda Boston, United States Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Noticeand Terms of Use. I further attest that all information I submit ...
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Manager, Global Regulatory Affairs CMC
2 days ago
Takeda Pharmaceutical Company Ltd Boston, MA, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I subm ...
Director, Regulatory CMC - Boston, MA, United States - Cerevel Therapeutics
Description
Boston, MA (Remote)Development – Global Regulatory and Access Solutions /RemoteCompany OverviewCerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases.
We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity.
Our portfolio of pre-commercial neuroscience assets targets a broad range of central nervous system (CNS) disorders, including schizophrenia, epilepsy, Parkinson's disease and substance use disorder.
Headquartered in the Greater Boston area, we are bold thinkers, deep experts, resilient pathfinders, and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on people's lives.
Cerevel aspires to develop and nurture a culture characterized by trust, respect, courage, curiosity, and compassion, with a relentless focus on mission and results.
Our patient-centricity guides our purpose, how we treat each other and what we work on every day.The successful candidate will bring their own unique thinking and approach to Cerevel while sharing our core values and convictions.
Role Summary:
Reporting to the Senior Director, Head of Regulatory CMC, the successful candidate will provide expertise in translating regulatory CMC requirements into innovative, efficient and practical strategies for development of Neuroscience candidates.
The candidate will partner with Global Regulatory Leads (GRLs) and Technical Operations Leads and have primary responsibility for the chemistry, manufacturing and controls strategy and writing details for Cerevel's products and regulatory submissions.
The candidate may also manage the activities of other CMC regulatory affairs staff or contract regulatory support in the performance of the duties outlined below.
Key ResponsibilitiesCreate and deliver effective CMC strategies with appropriate risk assessment for projects across the development spectrum (Phase 1 through commercialization and LCM).
Partner with Global Regulatory Lead and Technical Operations Team lead to ensure CMC risks are appropriately communicated to Product Teams and senior managementServe as primary author of Module 3 documentation for regulatory submissions while partnering with cross functional SMEsProvide strategic input to technical teams to ensure product development meets global regulatory requirementsReview and provide assessments for change controls partnering with Quality colleagues to ensure investigational and commercial products maintain regulatory complianceProvide and communicate CMC regulatory/GMP guidance documents and regulations regarding applicability and impact to internal programs.
Assist in the development, writing and implementation of internal guidance documentation for CMC regulatory and technical operations colleaguesEngage in appropriate activities in order to influence the regulatory environment through Health Authorities contacts and Trade Associations (eg, BIO) as appropriateRequired QualificationsMinimum of 10 years of experience working in the pharmaceutical/biotechnology industry with direct experience in CMC Regulatory Affairs; Regulatory Affairs Certification (RAC) a plusDemonstrated experience in the preparation and submission of INDs, CTAs, and NDAs/Marketing ApplicationsExperience with Health Authority reviews, queries and responses Expert knowledge with GMP/ICH requirements and guidance in major markets, especially US and EU Excellent written and verbal communication skills.
Strategic thinker, planner with excellent organizational skillsProven ability to effectively work collaboratively in cross functional teamsDesired QualificationsDirect experience leading a team/asset through the NDA process for approvalExperience with ex-US regulatory authorities desirableEducationBS scientific degree essential.
Master's degree in science within a relevant scientific discipline required; PharmD, PhD or MD and/or a business qualification (DMS, MBA) may be an advantage but not essentialCerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.