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Associate Director
3 weeks ago
Project Citizenship Boston, United StatesAre you passionate about positively impacting the lives of immigrants in Boston and beyond? Project Citizenship is seeking a dedicated Associate Director to join our dynamic team. As Associate Director, you will lead a core team of staff members and active volunteers, all committ ...
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Associate Director
3 weeks ago
YMCA Boston, United StatesAssociate Director - Aquatics, Woburn · Job Description · This position is primarily responsible, under the supervision of the Aquatic Director, for assisting in the planning, organizing, directing, budgeting and evaluating those programs within his/her program area in accordan ...
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Associate Director
3 weeks ago
YMCA Boston, United StatesAssociate Director - Aquatics, Woburn · Job Description · This position is primarily responsible, under the supervision of the Aquatic Director, for assisting in the planning, organizing, directing, budgeting and evaluating those programs within his/her program area in accordan ...
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Associate Director
1 week ago
YMCA Boston, United StatesAssociate Director - Aquatics, Woburn · Job Description · This position is primarily responsible, under the supervision of the Aquatic Director, for assisting in the planning, organizing, directing, budgeting and evaluating those programs within his/her program area in accordan ...
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Associate Director
1 week ago
Tufts University Boston, United StatesOverviewNew Entry Sustainable Farming Project (New Entry) improves our local and regional food systems by training the next generation of farmers to produce food that is sustainable, nutritious, and culturally-appropriate and making this food accessible to individuals regardless ...
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Associate Director
2 weeks ago
YMCA Boston, United StatesAssociate Director - Aquatics, Woburn · Job Description · This position is primarily responsible, under the supervision of the Aquatic Director, for assisting in the planning, organizing, directing, budgeting and evaluating those programs within his/her program area in accordan ...
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Associate Director
3 weeks ago
YMCA Boston, United StatesAssociate Director - Aquatics, Woburn · Job Description · This position is primarily responsible, under the supervision of the Aquatic Director, for assisting in the planning, organizing, directing, budgeting and evaluating those programs within his/her program area in accordan ...
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Associate Director
1 week ago
CrossCountry Consulting Boston, United StatesAssociate Director - FP&A Transformation · From the beginning, our goal was to establish an advisory firm that stands apart from the rest – one that is grounded in our Core Values and dedicated to creating a positive experience not just for our clients, but for our people too. W ...
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Associate Director
1 week ago
Bay Cove Human Services, Inc. Boston, United StatesBay Cove Human Services' mission is to partner with people to overcome challenges and realize personal potential. Bay Cove pursues this mission by providing individualized and compassionate services to people facing the challenges associated with developmental disabilities, menta ...
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Associate Director
3 weeks ago
CrossCountry Consulting Boston, United StatesFrom the beginning, our goal was to establish an advisory firm that stands apart from the rest - one that is grounded in our Core Values and dedicated to creating a positive experience not just for our clients, but for our people too. We firmly believe in the strength of collabor ...
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Associate Director
3 weeks ago
Cognizant Technology Solutions Boston, United States OTHEROverview: · Join Cognizant as an inspiring leader within the Program & Project Management community. This key role is responsible to design transition solutions and to lead/drive transition of multi-service, multi-geo and multi-vendor transitions. Successful candidates will not o ...
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Associate Director
3 weeks ago
Cognizant North America Boston, United StatesOverview: · Join Cognizant as an inspiring leader within the Program & Project Management community.This key role is responsible to design transition solutions and to lead/drive transition of multi-service, multi-geo and multi-vendor transitions. Successful candidates will not o ...
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Associate Director
1 week ago
Aon Boston, United StatesAon is Looking for a Reinsurance Director · As part of an industry-leading team, you will help empower results for our clients by delivering solutions on our Reinsurance Solutions line. · Job Responsibilities: · Works with complex data to create comprehensive and accurate intern ...
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Associate Director
20 hours ago
Gartner Boston, United StatesAbout the role · Gartner's Consulting business is an extension of Gartner's industry-leading IT Research. From CIOs, to leaders in business and government, we help Gartner clients across enterprises translate insights into transformational actions and achieve their mission-criti ...
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Director/Associate Director, Development
3 weeks ago
Shine Associates Boston, United StatesDIRECTOR/ASSOCIATE DIRECTOR, DEVELOPMENT · POSITION SPECIFICATION · Shine Associates, LLC has been retained to search, identify and recruit a Director/Associate Director, Development on behalf of our client ('Company'). This person will report directly to the Senior Director, Dev ...
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Associate Director/Director, Biomarkers
3 weeks ago
PepGen Boston, United StatesPepGen is looking for a highly motivated Associate Director or Director level Biomarker scientist who will contribute to the preclinical/clinical development to support and expand their current and future pipeline. This person will be a key contributor to the clinical biomarker d ...
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Associate Director/Director, Facilities
11 hours ago
Chroma Medicine, Inc. Boston, United StatesAssociate Director/Director, Facilities & Laboratory Operations · Chroma Medicine is pioneering a new class of genomic medicines that harness epigenetics, natures innate mechanism for gene regulation, revolutionizing the treatment of genetically driven diseases. As a start-up ge ...
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Associate Director/Director, Biostatistician
2 weeks ago
Kura Oncology, Inc. Boston, United StatesAre you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of. · At ...
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Associate Director/Senior Associate
3 weeks ago
JobRialto Boston, United StatesJob Description · Client Private Equity & Credit ("Client PE&C" or "PE&C") offers discretionary and non-discretionary investment management and other services with respect to private equity co-investments, private equity funds ("Fund-of-Funds"), mezzanine securities, leveraged s ...
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Associate Medical Director
1 week ago
State of Massachusetts Boston, United StatesThe Massachusetts Mental Health Center (MMHC) operated by the Department of Mental Health (DMH) seeks a full-time board-certified Psychiatrist to serve as the facility Associate Medical Director and to help lead our thriving state operated community Medical Director, Director, As ...
Regulatory CMC Director or Associate Director - Boston, United States - Dennis Partners
3 weeks ago
Description
Our client is developing and commercializing innovative ophthalmic products for the treatment of serious eye disorders.They 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 closely with cross-functional teams, CMOs, and Health Authorities. This company offers a science-based, entrepreneurial culture, excellent employee benefits, and flexible work arrangements. With their lead program going into global Phase three studies this year, now is an exciting time to join this growing organizationResponsibilities:
Provide regulatory CMC strategic leadership to support development of multiple innovative products including life-cycle management and post-marketing changes.
Prepare and submit high-quality CMC sections of INDs, IMPDs, CTAs, and original marketing applications (NDAs/MAAs).
Lead CMC-specific meetings and resolve CMC issues through negotiations with regulatory agencies.
Review and approve CMC technical reports as source documents, as per procedures, in coordination with Quality.
Develop CMC response strategies and submissions to health authorities.
In coordination with Regulatory Operations, manage completion of CMC submission documents and other assigned tasks within established timelines and with high quality.
Lead the preparation for CMC meetings with health authorities and develop CMC section of briefing packages.Shepherd proactive interactions with regulators; prepare and submit responses to CMC questions.
Support R&D and the Quality Group with regulatory agencies during cGMP and pre-approval inspections.
Provide critical review of all CMC information supporting regulatory applications, including CMC sections of Investigators' Brochure, SmPC, and labeling.
Assess proposed change controls (e.g., manufacturing process changes) and provide strategic regulatory guidance to enable regulatory and filing implementation.
Identify and assess CMC regulatory risks on key program strategies.
Prepare and deliver effective presentations for internal and external audiences.
Ensure productive interactions between Regulatory CMC, R&D, Quality, and Technical Operations, along with business partners and CMOs.
Develop Standard Operating Procedures (SOPs) and Work Instructions (WIs) as directed by the Senior Director CMC Regulatory Affairs.
Qualifications:
Bachelor degree in a scientific discipline. Advanced degree (MS, PharmD or PhD) preferred.
Eight or more years in CMC Regulatory for small molecule pharmaceutical drugs.
Experience with drug-device combinations products (e.g., pre-filled syringes and injectables) and ophthalmic products highly desired but not required.
Must have regulatory CMC experience supporting both development projects and commercial products.
Experience writing CMC sections for INDs, CTAs, NDAs and supportive amendments or supplements.
Must have experience working directly with the FDA. Experience with global regulatory authorities (EMA, Health Canada, etc) a plus.
Strong knowledge of eCTD elements and structure and regulatory technical writing skills.
Strong knowledge of current Good Manufacturing Practices (GMP), drug development regulations and guidelines including ICH, and FDA guidelines
Proficient in Microsoft Office Suite (Outlook, Teams, Word, etc.) and other applications (e.g. Adobe Acrobat and eCTD viewers).
Demonstrated ability to work well with other accomplished professionals within and across functions/teams.
Strong written and oral communication skills.
Detail oriented and well organized. Ability to multi-task and shift priorities rapidly to meet tight deadlines.
Independently motivated and solution oriented.
Must be a collaborative team player who is comfortable wearing many hats in a small biotech environment.
Able to be flexible and comfortable with ambiguity.
This is a hybrid/onsite position in the Greater Boston Area. This individual must be onsite 2-3 days a week.
The budgeted salary range for this position is US$150,000 to $225,000 plus an annual target bonus, equity, and comprehensive benefits.
Actual salaries may be based on a number of factors including, but not limited to, a candidate's skill set, experience, education, and other qualifications.
Posted salary ranges do not include incentive compensation or any other type of renumeration.#J-18808-Ljbffr
