Current jobs related to Project Manager, Cmc Regulatory Affairs - Waltham - GSK
-
CMC Regulatory Affairs Expert
3 weeks ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeJob SummaryThe Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is a critical role at Dyne Therapeutics, responsible for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval.Key ResponsibilitiesLead CMC regulatory execution for specific programs at all stages of...
-
Associate Director, Regulatory Affairs CMC
2 months ago
Waltham, United States Dyne Therapeutics Full timeCompany Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle...
-
Regulatory CMC Manager
4 days ago
Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full timeJob Title: Manager, Regulatory CMCDeciphera Pharmaceuticals is seeking a highly skilled Manager, Regulatory CMC to join our Post-Approval Group within the Regulatory Affairs Organization. This role will be responsible for leading and executing post-approval CMC regulatory activities in support of our globally approved marketing applications.Key...
-
Regulatory CMC Manager
2 weeks ago
Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full timeJob SummaryWe are seeking a highly skilled Manager, Regulatory CMC to lead our Post-Approval Group within the Regulatory Affairs Organization at Deciphera Pharmaceuticals. The successful candidate will be responsible for executing post-approval CMC regulatory activities in support of our globally approved marketing applications.Key...
-
Associate Director, Regulatory CMC
3 days ago
Waltham, United States Dyne Therapeutics Full timeThe Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval. This position supports Dyne’s clinical registration, commercial development, and manufacturing efforts, as applicable. This position...
-
Associate Director, Regulatory CMC
3 days ago
Waltham, United States Dyne Therapeutics Full timeThe Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval. This position supports Dyne’s clinical registration, commercial development, and manufacturing efforts, as applicable. This position...
-
Regulatory Affairs Director
6 days ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeJob SummaryThe Associate Director, Regulatory Affairs CMC is a critical role at Dyne Therapeutics, responsible for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval.Key ResponsibilitiesLead CMC regulatory execution for specific programs at all stages of developmentProvide strategic...
-
Regulatory Affairs Director
3 weeks ago
Waltham, Massachusetts, United States Dyne Tx Full timeAbout Dyne TxDyne Tx is a clinical-stage biotechnology company dedicated to developing innovative therapeutics for people living with genetically driven diseases.Job SummaryWe are seeking a highly experienced Regulatory Affairs Director to lead our CMC regulatory strategies for our programs in early and late-stage development. This role will support our...
-
Regulatory Affairs Director
2 days ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeJob Title: Associate Director, Regulatory CMCThe Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) plays a pivotal role in executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval. This position supports Dyne's clinical registration, commercial development, and...
-
Senior Manager, Regulatory Affairs
3 weeks ago
Waltham, Massachusetts, United States Alkermes, Inc. Full timeAbout the RoleAlkermes, Inc. is seeking a highly skilled Senior Manager to join our Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs team. As a key member of our team, you will be responsible for supporting commercial CMC and GMP activities for contracted manufactured products and our European office.Key ResponsibilitiesRegulatory...
-
Regulatory Affairs Director
2 weeks ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeJob SummaryThe Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) will be responsible for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval.Key ResponsibilitiesLead CMC regulatory execution for specific programs at all stages of developmentProvide strategic...
-
Director, Regulatory Affairs Project Manager
3 weeks ago
Waltham, United States Dyne Therapeutics Full timeCompany Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle...
-
Regulatory Affairs Director
2 weeks ago
Waltham, Massachusetts, United States Ventus Therapeutics Full timeAbout Ventus Therapeutics:We are a biopharmaceutical company leveraging cutting-edge structural biology and computational chemistry tools to develop innovative small molecule medicines for challenging targets. Our initial focus areas include immunology, inflammation, and neurology.Our proprietary drug discovery platform, ReSOLVE, enables us to discover and...
-
Associate Director/Director, Regulatory CMC
2 months ago
Waltham, United States Upstream Bio Full timeUpstream Bio is developing innovative therapeutics in inflammation. We are a nimble company with solid financial backing that has raised $400M from high-quality investors. We are developing a monoclonal antibody targeting validated biology and are focused on our two Phase 2 studies in asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) in 2024. Our...
-
Associate Director/Director, Regulatory CMC
2 months ago
Waltham, United States Upstream Bio Full timeUpstream Bio is developing innovative therapeutics in inflammation. We are a nimble company with solid financial backing that has raised $400M from high-quality investors. We are developing a monoclonal antibody targeting validated biology and are focused on our two Phase 2 studies in asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) in 2024. Our...
-
Head of Regulatory Affairs
3 weeks ago
Waltham, United States Muraloncology Full timeDescription:We are looking for a dynamic Head of Regulatory Affairs whose responsibilities include regulatory oversight and strategic development of our products throughout the product lifecycle. This individual will lead Regulatory Strategy, Regulatory Operations, and Regulatory CMC. Success in this role requires strong leadership skills, exceptional...
-
Senior Director, Head of Regulatory Affairs
3 weeks ago
Waltham, Massachusetts, United States Ventus Therapeutics Full timeAbout Ventus Therapeutics:We are a biopharmaceutical company leveraging cutting-edge structural biology and computational chemistry tools to develop novel small molecule medicines for challenging targets, with an initial focus on immunology, inflammation, and neurology.Our proprietary drug discovery platform, ReSOLVE, enables us to discover and develop...
-
Waltham, Massachusetts, United States Dyne Therapeutics Full timeJob SummaryThe Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is a critical role at Dyne Therapeutics, responsible for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval.Key ResponsibilitiesLead CMC regulatory execution for specific programs at all stages of...
-
Senior Director, Head of Regulatory Affairs
1 month ago
Waltham, United States Ventus Therapeutics Full timeAbout us:Ventus Therapeutics is a biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets, with an initial focus on immunology, inflammation and neurology.Our proprietary drug discovery platform, ReSOLVE, gives us the ability to discover and develop...
-
Senior Director, Head of Regulatory Affairs
3 weeks ago
waltham, United States Ventus Therapeutics Full timeAbout us:Ventus Therapeutics is a biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets, with an initial focus on immunology, inflammation and neurology.Our proprietary drug discovery platform, ReSOLVE, gives us the ability to discover and develop...
Project Manager, Cmc Regulatory Affairs
3 months ago
**Site Name**: USA - Pennsylvania - Upper Providence, GSK House, UK - Hertfordshire - Ware, USA - Maryland - Rockville, USA - Massachusetts - Waltham, Zug House
**Posted Date**: May 22 2024
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together.
The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
**Key Responsibilities**:
- Responsible for the global CMC regulatory activities for assigned projects and responds readily to changing events and priorities.
- Works in cross-functional matrix project teams, which include colleagues from regulatory, development, quality and manufacturing ensuring adequate interaction and partnership in order to define proper regulatory CMC filing strategy.
- Maintains high quality standards and seeks to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.
- Ensures regulatory compliance is maintained and shares best-practices and learnings within the CMC Regulatory teams and other impacted functions.
- Engages in CMC Subject Matter Expert activities internally (for increased compliance, harmonisation and efficiency)
- Will sometimes deliver CMC regulatory strategy to support major inspections (eg PAIs) with managerial support
**Basic Qualifications**:
- BS in a Life Sciences or related field.
- Two or more years of experience in Chemistry, Manufacturing and Controls (CMC) regulatory affairs or product development experience with direct involvement in regulatory submission preparation across all stages of development through to early life cycle submissions.
- Two or more years of experience in drug development, manufacturing processes and supply chain and may have a specialized area of expertise
**Preferred Qualifications**:
- MS in a Life Sciences or related field.
- RAPS Certification
- Biologics experience
- Veeva Vault experience
- Pre-approval experience (phase 1 to phase 3 submission experience)
- Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development.
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
**Why GSK?**
**Uniting science, technology and talent to get ahead of disease together.**
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
**Important notice to Employment businesses/ Agencies**
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an
