- Ensures high-quality and on-time submissions, including for INDs, IMPDs, CTAs and BLAs, that align with company strategies and Health Authority requirements. This includes planning, coordination and tracking the CMC dossier towards submission milestones. Interact with cross-functional departments to ensure deliverables are met according to the corporate goals.
- Coordinate responses to CMC-related inquiries from regulatory agencies with thorough submission management
- Support preparation for Health Authority CMC meetings and development of meeting information packages
- Provide regulatory and scientific expertise to review CMC source documentation in support of dossiers.
- Develops relationships with and proactively communicates issues with key internal colleagues.
- Develops and implements best practices based on current and emerging industry trends, and relevant Health Authority guidance and regulations.
- Bachelor of Science in a scientific discipline, advanced degree preferred
- 6+ years biopharmaceutical experience with a CMC focus
- At least 3 years Regulatory CMC biopharmaceutical experience, biologics experience required
- Proven ability to manage projects. Capable of performing independently and thinking analytically and creatively to solve problems.
- Excellent oral and written communication
- Willingness to work through change and work toward continuous improvement
- Experience in writing and developing documents with scientific content for IND and BLA submissions in eCTD format
- Knowledge of CMC drug development process/requirements within pharmaceutical and/or biopharmaceutical industries and GMP requirements as it relates to regulatory requirements for assessing changes throughout development,
- Understanding of scientific principles and capable of interpreting regulatory requirements.
- Understanding of regulations and guidance (examples: CFR, FDA guidance, EU, ICH, Health Canada, ISO)
- Direct experience participating in regulatory interactions with health authorities
- Ability to influence decisions with effective communication skills
-
Associate Director
1 week ago
Riverside Research Institute Lexington, United StatesRiverside Overview: · Riverside Research is an independent National Security Nonprofit dedicated to research and development in the national interest. We provide high-end technical services, research and development, and prototype solutions to some of the countrys most challengin ...
-
Associate Director
1 week ago
BioSpace Lexington, United StatesJob Details · About the Department · Our Boston Research & Development hub, anchored in the greater Boston area, brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown and Cambridge reflect the full R&D continuum, from ...
-
Associate Director
2 weeks ago
Accede Solutions Inc. Lexington, United StatesJob Details: · Job Title : Associate Director · Location : Hybrid in Lexington, MA · Duration: Full-Time (Permanent) · Shift : Business Hours/ Day Shift · Days/Week: 5 Days a week · Salary :- · $150k/Annum · Responsibilities: · Ensures high-quality and on-time submissions, incl ...
-
Associate Director
2 weeks ago
BioSpace Lexington, United StatesJob Details · About the Department · Our Boston Research & Development hub, anchored in the greater Boston area, brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown and Cambridge reflect the full R&D continuum, from ...
-
Associate Director of Admissions
2 weeks ago
InsideHigherEd Lexington, United States Administrative Jobs ,The Associate Director is a seasoned admission professional responsible for undergraduate recruitment, assessment and yield activities in support of the University's annual enrollment goals. The Associate is a senior member of the admission officer cadre, managing a recruitment t ...
-
Associate Director
4 weeks ago
Novo Nordisk Lexington, United States Full timeAbout the Department · Our Boston Research & Development hub, anchored in the greater Boston area, brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown and Cambridge reflect the full R&D continuum, from early research ...
-
Student Conduct Director Associate
2 weeks ago
InsideHigherEd Lexington, United StatesJob Title:Student Conduct Director Associate · Requisition Number:RE45235 · Working Title:Associate Director Student Conduct · Department Name:1B420:Student Conduct · Work Location:Lexington, KY · Grade Level:46 · Salary Range:$51,491-84,950/year · Type of Position:Staff · Positi ...
-
Associate Director, Corporate Communications
4 weeks ago
Kiniksa Pharmaceuticals Lexington, United StatesAssociate Director, Corporate Communications · Full Time · Lexington, MA, US · 30+ days agoRequisition ID: 1417 · Apply · Reporting to the Director of Investor Relations, Kiniksa Pharmaceuticals is seeking an Associate Director, Corporate Communications. This role will be respons ...
-
College Philanthropy Director Associate
1 day ago
University of Kentucky Lexington, United States Full time· Job Title · College Philanthropy Director Associate · Requisition Number · RE45723 · Working Title · Director of Philanthropy - Social Work · Department Name · 14000:Office Of Development · Work Location · Lexington, KY · Grade Level · 48 · Salary Range · $62,310-102,821/year ...
-
Associate Director Corporate Communications
4 weeks ago
GQR Lexington, United StatesJoin a dynamic team in Lexington, MA, where you'll contribute to the success of a leading pharmaceutical company in the role of Associate Director, Corporate Communications. Reporting directly to the Director of Investor Relations, this position involves crafting and implementing ...
-
Associate Director Investor Relations
3 weeks ago
Kiniksa Pharmaceuticals Lexington, United StatesReporting to the Senior Director of Investor Relations, Kiniksa Pharmaceuticals is seeking an Associate Director, Investor Relations. This role will be responsible for helping to implement Kiniksa's investor relations strategy and programs. · This role is based in our Lexington, ...
-
Associate Director, Neuroscience
3 weeks ago
Voyager Therapeutics, Inc. Lexington, United StatesAbout Voyager Therapeutics · Voyager Therapeutics, Inc. (Nasdaq: VYGR) is a biotechnology company dedicated to leveraging the power of human genetics to modify the course of - and ultimately cure - neurological diseases. Our pipeline includes programs for Alzheimer's disease, am ...
-
Associate Director for Communications
3 weeks ago
Eliot's Lexington, United StatesMSPCC, a division of Eliot, is seeking a dynamic and creative professional with five years experiencein communications ormarketing. The ideal candidate will have a passion for the work of supporting children and families and for implementing communications strategies that engage ...
-
Associate Director, Portfolio
3 weeks ago
Valo Health Lexington, United StatesAbout Us · Valo Health is a technology company that is integrating human-centric data and AI-powered technology to accelerate the creation of life-changing drugs for more patients faster. Valo was created with the belief that the drug discovery and development process can and sh ...
-
Associate Director, Marketing Services
4 weeks ago
Takeda Lexington, United States Full timeDescription · About the role: · Join Takeda as an Associate Director, where you will play a crucial role in driving and navigating transformative initiatives while fostering a culture of continuous improvement, adaptability, and growth. You will also effectively communicate and ...
-
Associate Director
4 weeks ago
Novo Nordisk A/S Lexington, United StatesWe are looking to hire an Associate Director of Clinical Operations. This is a unique opportunity to work in a growing Clinical Operations Department that manages multiple early-stage clinical programs based on an innovative RN - Ai technology platfo Clinical, Operations, Directo ...
-
Associate Director
4 weeks ago
BioSpace Lexington, United StatesJob Details · About the Department · The Data Science organization within Novo Nordisk's global Development organization is responsible for clinical data capture, storage, analysis, modeling and simulation as well as the application of artificial intelligence/machine learning. T ...
-
Associate Director
6 days ago
Riverside Research Lexington, United StatesRiverside Overview · If you want to know about the requirements for this role, read on for all the relevant information. · Riverside Research is an independent National Security Nonprofit dedicated to research and development in the national interest. We provide high-end techni ...
-
Associate Director of Law School Advancement
2 weeks ago
InsideHigherEd Lexington, United States Administrative Jobs ,The Associate Director of Law School Advancement serves as a major gifts officer for the School of Law and develops meaningful relationships with alumni who provide major philanthropic support for the School of Law. Reporting to the Assistant Dean for Law School Advancement, the ...
-
Associate Director
2 weeks ago
Novo Nordisk Lexington, United States Full timeAbout the Department · Our Boston Research & Development hub, anchored in the greater Boston area, brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown and Cambridge reflect the full R&D continuum, from early research ...
Associate Director - Lexington, United States - Accede Solutions Inc (accedesol)
Description
Job Details:
Job Title : Associate Director
Location : Hybrid in Lexington, MA
Duration: Full-Time (Permanent)
Shift : Business Hours/ Day Shift
Days/Week: 5 Days a week
Salary :- $150k/Annum
Responsibilities:
Basic Requirements:
Preferred Requirements:
