- Bachelor of Science Degree in a relevant area is required. Advanced science degree is preferred.
- RAC certification or other equivalent is preferred.
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Associate Director
3 weeks ago
Northeastern University Boston, United StatesAbout the Opportunity · **Responsibilities**: · Reporting to the Operations Director - ISEC and EXP, the Associate Director - Lab Operations, responsible for daily management of ISEC and EXP shared labs and core facilities, and supports the Operations Director needs of ISEC and E ...
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Associate Director, Program Management
1 week ago
IQVIA Bridgewater, United StatesThe Program Associate Director works with Leadership and Program team to effectively oversee the programs and manage Client relationship. Collaborates with Client management team to understand the programs short term and long-term goals of growth and development. This is a superv ...
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Associate Director
2 weeks ago
AstraZeneca Waltham, United States**Associate Director (Device Development)** · At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident ...
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Insmed Incorporated Bridgewater, United StatesCompany Description: · **About Insmed** · Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentali ...
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Associate Director
3 weeks ago
Project Citizenship Boston, United States**Key Responsibilities Include**: · - Lead and support a dedicated team of staff and volunteers, fostering a collaborative work culture so that everyone feels welcome, supported, and encouraged to reach their full potential. · - Oversee and manage program operations, ensuring hig ...
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Associate Director
2 weeks ago
Pierce School Extended Day Program Brookline, United StatesJob Summary: · **Duties**: · - Work together with the Program Director To: · - Manage program operations and ensure compliance with all EEC regulations · - Conduct employee onboarding and managment of staff benefits · - Assist with hiring, supervison and training of program staff ...
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Associate Director
2 weeks ago
Novo Nordisk Watertown, United States**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 early resea ...
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Associate Director
6 days ago
Thermo Fisher Scientific Cambridge, United StatesThermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our customers to make the world healthier, safer, and cleaner. · Within our Anal ...
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Associate Director of Music
1 week ago
Archdiocese of Boston Braintree, United StatesLocated in the heart of bustling Harvard Square, Cambridge, MA, Saint Paul's Church has been a beacon of of traditional Catholic liturgy and worship for over a century. Renowned for its superb acoustics, the church frequently hosts concerts by such famed groups as the Tallis Scho ...
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Associate Director, IT Security
3 weeks ago
Year Up Boston, United StatesOVERVIEW: · The Associate Director of IT Security will report directly to the Chief Technology Officer. They will work cross-functionally across Transformation and Technology, and other departments within Year Up, to ensure that technology use and business processes adhere to acc ...
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Associate Director of Dei
2 weeks ago
Buckingham Browne & Nichols School Cambridge, United States**Start Date**:August 2024 · **Reports to**:Diversity, Equity, Inclusion & Global Education Officer · **Job Summary**: · BB&N is seeking a dedicated and adaptable person to join our team as the Associate Director of Diversity, Equity, Inclusion & Global Education (DEIG). Tasked w ...
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Associate Director, Loans
1 week ago
Northeastern University Boston, United StatesAbout the Opportunity · The Associate Director, Loans & Operations will direct and manage operations for the full complement of university disbursement processes and all educational loan processing within Student Financial Services. Disbursement processing includes but is not lim ...
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Associate Director, Payroll
2 weeks ago
Arrowstreet Capital Boston, United StatesJob Overview · We are a high growth, fast-paced firm looking for a Payroll Associate Director to join our Finance & Administration Department. This position sits under the CFO reporting into the Payroll Director. The Payroll Associate Director will be part of the team responsible ...
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Agios Pharmaceuticals Cambridge, United States**Director / Associate Director, Commercial Analytics** · **Who we are**: · Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply ab ...
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Associate Athletic Director
2 weeks ago
Brookline Public Schools Brookline, United States**JOB TITLE**:ASSOCIATE ATHLETIC DIRECTOR** · **DATE REVISED**:May 3, 2024 · **REPORTS TO**:Director of Athletics · **POSITION OVERVIEW**: Provide assistance to the Director of Athletics · **_ · KNOWLEDGE, SKILLS, & ABILITIES_**. · **QUALIFICATIONS- REQUIRED**: · - Demonstrated a ...
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Associate Director, Fp&a
3 weeks ago
Moderna Cambridge, United States**The Role**: · This role, based in Cambridge, MA, and reporting to the Executive Director FP&A for R&D, will be an onsite position at least 70% of the time, reflecting our commitment to fostering a collaborative environment that encourages collective action and impactful results ...
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American Red Cross Dedham, United States**_ By joining the American Red Cross you will touch millions of lives every year and experience the greatness of the human spirit at its best. Are you ready to be part of the world's largest humanitarian network?_**: · **Join us—Where your Career is a Force for Good**: · **_ WHY ...
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Associate Director of Finance
2 weeks ago
VBeyond Healthcare Boston, United States**ESSENTIAL RESPONSIBILITIES / DUTIES**: · **Responsible for managing all aspects of financial reporting, external audit and tax services. Specific job duties include the following**: · - Lead the daily activities in the financial reporting, external audit and tax areas to ensure ...
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Associate Director of Finance
2 weeks ago
VBeyond Healthcare Boston, United States**ESSENTIAL RESPONSIBILITIES / DUTIES**: · **Responsible for managing all aspects of financial reporting, external audit and tax services. Specific job duties include the following**: · - Lead the daily activities in the financial reporting, external audit and tax areas to ensure ...
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Associate Director, HEOR
1 week ago
Bausch Health Bridgewater, United StatesBausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry. We are delivering on ...
Regulatory Affairs Associate Director - Bridgewater, United States - Gan & Lee Pharmaceuticals Ltd
3 weeks ago
Description
This position reports to the VP, Global Regulatory Affairs. The incumbent responsible for supporting the development and implementation of regulatory strategies, work closely with the cross functional asset teams to prepare, review and submit regulatory filing documents, manage documentation systems and maintain interactions with regulatory agenciesEducation and Credentials
Minimum Bachelor's degree in a scientific or related discipline, 5+ years of pharmaceutical industrial experience, at least 3 years of regulatory CMC experience with US product development.
Deep knowledge of US and EU regulations for biosimilars is preferred.Deep knowledge of regulations for drugs and biologics.
Familiarity with GLP/GCP/GMP, clinical laboratory regulations, and licensing.
Experience in various regulatory submissions and communication with regulatory agencies.
Experience in working in multi-culture/multi-countries environment is preferred.
Skills
Must be proficient with both English and Chinese, including written and oral communication
Demonstrated ability to manage multiple and diverse projects concurrently.
Demonstrated ability to develop positive relationships and collaborations.
Strong analytical skills; a strategic thinker, planner, and implementer.
Ability to operate independently with minimal supervision.
Strong proficiency in major Microsoft Office products (i.e., Word, Excel, PowerPoint, Project).
Enthusiastic, genuine, ethical, fair, and loyal to the organization and its vision and goals.
Responsibilities
Actively contribute to the development of regulatory strategies for investigational products in Investigational New Drug (IND)/ Clinical Trial Applications (CTA), Biologics Licensing Application (BLAs)/ Marketing Authorization Application (MAA), through evaluating scientific merits of Chemistry, Manufacturing and Control (CMC) and nonclinical study data package;
Participate as Global Product Strategy Lead in cross-functional teams, including but not limited to, contract research organizations (CROs), functional working groups, global regulatory team, submission team, product development team, to ensure compliance with regulatory requirements;
Author
Module 2 and 3 documents for regulatory filings such as INDs/ IMPDs/ CTAs/ MAAs/NDAs/ global registrations and eCTD submissions, ensuring that they meet current regulatory standards.
Drive the preparation and review of regulatory submissions, such as INDs, BLAs, MAAs, meeting packages to ICH member Health Agencies, and supplemental filings ensuring regulatory documents are written per guidelines and timelines.
Manage and track filing submission dates, questions from Regulatory Health Authorities, responses, and approval dates.The following questions are entirely optional.
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