- Create 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 management
- Serve as primary author of Module 3 documentation for regulatory submissions while partnering with cross functional SMEs
- Provide strategic input to technical teams to ensure product development meets global regulatory requirements
- Review and provide assessments for change controls partnering with Quality colleagues to ensure investigational and commercial products maintain regulatory compliance
- Provide 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 colleagues
- Engage in appropriate activities in order to influence the regulatory environment through Health Authorities contacts and Trade Associations (eg, BIO) as appropriate
- Minimum of 10 years of experience working in the pharmaceutical/biotechnology industry with direct experience in CMC Regulatory Affairs; Regulatory Affairs Certification (RAC) a plus
- Demonstrated experience in the preparation and submission of INDs, CTAs, and NDAs/Marketing Applications
- Experience 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 skills
- Proven ability to effectively work collaboratively in cross functional teams
- Direct experience leading a team/asset through the NDA process for approval
- Experience with ex-US regulatory authorities desirable
- BS 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 essential
-
Associate Director, Cmc Regulatory
2 days 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 ...
-
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 ...
-
Director, Regulatory CMC
6 days 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 ...
-
Director, Regulatory CMC
1 week ago
Cerevel Therapeutics Boston, MA, United StatesBoston, 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 comb ...
-
Regulatory Affairs Cmc Officer
21 minutes 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 ...
-
Director, Regulatory CMC, Cell
2 weeks ago
Vertex Pharmaceuticals Boston, MA, United StatesDirector, Regulatory CMC, Cell & Gene Therapy (Boston) page is loaded · Director, Regulatory CMC, Cell & Gene Therapy (Boston) · Apply locations Boston, MA time type Full time posted on Posted 4 Days Ago job requisition id REQ-21607 Job Description · General Summary: The Dire ...
-
Director, CMC Regulatory Affairs
2 days 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 ...
-
Associate Director, CMC Regulatory
5 days 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 ...
-
Associate Director, CMC Regulatory
1 week ago
Sarepta Therapeutics Cambridge, MA, 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 ...
-
Associate Director, CMC Regulatory
6 days 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 ...
-
Associate Director, Regulatory Affairs CMC
6 days ago
Voyager Therapeutics, Inc. Cambridge, United StatesThe Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials under ...
-
Manager, Regulatory Affairs CMC
1 week 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 ...
-
Associate Director Regulatory Affairs CMC
6 days ago
PSG Global Solutions Cambridge, United StatesWe're looking for an · Associate Director Regulatory Affairs CMC , working in · Pharmaceuticals · and · Medical Products · industry in · Cambridge, Massachusetts, United States . · Leads development and execution of robust global regulatory CMC strategy for assigned progra ...
-
Vice President, Regulatory Affairs, CMC
1 week ago
Ultragenyx Somerville, United StatesWhy Join Us?Be a hero for our rare disease patients · At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease ...
-
Senior Manager, Regulatory CMC Lead
2 days ago
Biogen Cambridge, United StatesJob Description · About This Role · Please make sure you read the following details carefully before making any applications. · This role is responsible for Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and plan ...
-
Senior Manager, Regulatory Affairs CMC
6 days ago
Sarepta Therapeutics Cambridge, United StatesThe Senior Manager, Regulatory Affairs CMC supports RA CMC gene therapy development product(s) and provides support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs. They will work closely with subject matter experts within CMC technical operations and QA workin ...
-
Regulatory CMC Director or Associate Director
2 weeks ago
Dennis Partners Boston, MA, United StatesThey are seeking a Regulatory CMC Director or Associate Director who can develop CMC regulatory strategies and prepare CMC submissions for their clinical-stage small molecule drug programs and approved product. Reporting into the Senior Director Regulatory CMC, you will work clos ...
-
Director, Regulatory Affairs Vaccines CMC
1 week ago
Workday 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 sub ...
-
Director, Regulatory Affairs Vaccines CMC
5 days 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 ...
-
Senior Director, Regulatory Affairs CMC
1 week 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 ...
Director, Regulatory CMC - Cambridge, United States - Cerevel Therapeutics
Description
Company Overview
Cerevel 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 Responsibilities
Required Qualifications
Desired Qualifications
Education
Cerevel 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.
