Community affairs Jobs in Boston, MA
Create a job alert for this search
Community affairs • boston ma
Last updated: 2 days ago
Vice President, Regulatory Affairs.Client is a stem cell therapeutic company developing an innovative platform technology for generating self-renewing blood stem cells.
We have breakthrough potentia...Show moreLast updated: 30+ days ago
Student Affairs Coordinator, School of Dental Medicine, Student Affairs.The Student Affairs Coordinator plays a key role in enhancing the student / resident experience at the School of Dental Medicin...Show moreLast updated: 30+ days ago
Alkeus was founded in 2010 and since that time has been developing its lead compound gildeuretinol acetate (ALK-001).Designated as a breakthrough therapy and granted orphan drug status by the U.Foo...Show moreLast updated: 12 days ago
Director Of Medical Affairs plays a pivotal role in bridging the gap between clinical development and commercial operations, ensuring that medical strategies align with broader organizational goals...Show moreLast updated: 30+ days ago
Director, Regulatory Affairs - Pharmaceuticals.The Director, Regulatory Affairs - Pharmaceuticals provides leadership, people management, and technical expertise for the regulatory affairs team sup...Show moreLast updated: 2 days ago
PepGen is hiring a Director, Medical Affairs to lead the development and execution of the company’s global medical affairs strategy.
This role will play a critical leadership position within M...Show moreLast updated: 8 days ago
Chief External Affairs Officer.Grounded in equity, belonging, community voice, and meaningful partnership, the CEAO is a first-time role at YGB.
The CEAO will ensure that YGB's narrative, priorities...Show moreLast updated: 24 days ago
With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer.
Nuvalent is an exciting early-stage company, ...Show moreLast updated: 25 days ago
When our values align, there's no limit to what we can achieve.At Parexel, we all share the same goal - to improve the world's health.
From clinical trials to regulatory, consulting, and market acce...Show moreLast updated: 29 days ago
Are you passionate about making a difference in the world? Look no further!.The Borgen Project is an international organization that works at the political level to improve living conditions for pe...Show moreLast updated: 11 days ago
The Student Affairs Advisor will provide customer service to all students on the campus.S / he will be reporting to VP of Student Affairs and Career Development and will help to organize the campus e...Show moreLast updated: 30+ days ago
Nearly 37 million Americans are currently affected by Chronic Kidney Disease.At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of e...Show moreLast updated: 8 days ago
Develop and lead the Global Medical Affairs function at PepGen, including developing the strategy for external data dissemination across clinical and scientific audiences and engagement with key op...Show moreLast updated: 7 days ago
It’s not often you get the chance to make a real impact on the lives of others, while expanding your own possibilities.You’ll find that rare opportunity at PharmaEssentia USA.Join us, and let’s tra...Show moreLast updated: 30+ days ago
Nearly 37 million Americans are currently affected by Chronic Kidney Disease.At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of e...Show moreLast updated: 9 days ago
STUDENT AFFAIRS COORDINATOR, School of Dental Medicine, Student Affairs.STUDENT AFFAIRS COORDINATOR, School of Dental Medicine, Student Affairs.
Boston University Medical Campus > .The salary of th...Show moreLast updated: 30+ days ago
Director, Regulatory Affairs CMC.Generate : Biomedicines is a new kind of therapeutics company existing at the intersection of machine learning, biological engineering, and medicine pioneering Gene...Show moreLast updated: 16 days ago
Responsibilities : The primary job responsibility for this position is overseeing the day-to-day functions of the Dentsply Sirona Essential Dental Solutions team.
This role develops regulatory strate...Show moreLast updated: 30+ days ago
Manages a field team of regulatory compliance employees and provides regulatory expertise through leadership collaboration development management monitoring analyzing and evaluating the impact of e...Show moreLast updated: 8 days ago
- Promoted
Vice President Regulatory Affairs
Clinical Dynamix, Inc.Cambridge, MA, USFull-time
Quick Apply
- Promoted
STUDENT AFFAIRS COORDINATOR, School of Dental Medicine, Student Affairs
Boston UniversityBoston, MA, USFull-time
Vice President, Medical Affairs
Alkeus PharmaceuticalsCambridge, Massachusetts, USAFull-time
- Promoted
Sr. Director, Medical Affairs
Pivotal SolutionsBoston, MA, USFull-time
- Promoted
Director, Regulatory Affairs - Pharmaceuticals
Massachusetts StaffingBoston, MA, USFull-time
- Promoted
Director, Medical Affairs
PepGenBoston, MA, USFull-time
- Promoted
Chief External Affairs Officer
YMCA of Greater BostonBoston, MA, USPart-time
- Promoted
Vice President, Regulatory Affairs
Nuvalent, Inc.Cambridge, MA, United StatesFull-time
- Promoted
Senior Regulatory Affairs Associate (Regulatory Affairs Generalist)
ParexelBoston, MA, USFull-time
- Promoted
Political Affairs Internship
The Borgen ProjectChestnut Hill, MA, United StatesPart-time +1
- Promoted
Student Affairs Advisor
Computer Systems Institute IncCharlestown, MA, USFull-time
- Promoted
VP, Regulatory Affairs
AkebiaCambridge, MA, USFull-time
- Promoted
Director, Medical Affairs
OSIBoston, MA, United StatesFull-time
- Promoted
Senior Director, Medical Affairs
Pharmaessentia CorporationBoston, MA, United StatesFull-time
- Promoted
VP, Regulatory Affairs
Akebia TherapeuticsCambridge, MA, United StatesFull-time
- Promoted
STUDENT AFFAIRS COORDINATOR, School of Dental Medicine, Student Affairs
InsideHigherEdBoston, Massachusetts, United StatesFull-time
- Promoted
Director, Regulatory Affairs CMC
Generate BiomedicinesSomerville, MA, USFull-time
- Promoted
Regulatory Affairs Manager
Katalyst Healthcares & Life SciencesBoston, MA, USFull-time
Senior Director Regulatory Affairs
Fresenius Medical CareWaltham, Massachusetts, USAFull-time
- dump truck (from $ 43,875 to $ 453,863 year)
- sports medicine (from $ 57,200 to $ 450,000 year)
- dermatology (from $ 56,550 to $ 400,000 year)
- commercial loan officer (from $ 86,580 to $ 350,916 year)
- anesthesiologist (from $ 25,000 to $ 337,500 year)
- owner operator (from $ 50,000 to $ 260,000 year)
- hospitalist (from $ 46,840 to $ 260,000 year)
- physician (from $ 100,000 to $ 250,000 year)
- associate dentist (from $ 90,008 to $ 250,000 year)
- psychiatrist (from $ 146,250 to $ 245,000 year)
The average salary range is between $ 58,894 and $ 127,396 year , with the average salary hovering around $ 77,966 year .
Vice President Regulatory Affairs
Clinical Dynamix, Inc.Cambridge, MA, US30+ days ago
Job type
- Full-time
- Quick Apply
Job descriptionPassionate about our mission to transform the lives of patients who require transplants Extensive drug development leadership experience in biotech / biopharmaceutical R&D across all stages of the product lifecycle BS or equivalent degree in life sciences required. Advanced degree and / or professional certification preferred 15+ years in the pharmaceutical or biotech industry, 4+ years in Cell Therapy with direct regulatory experience with IND and NDA submissions and FDA / EMA interactions for drugs in development In depth knowledge of current FDA and EMA regulations and guidance documents Experience in hematology and / or immunology is considered a plus Global experience with prior success interacting with US, EU, and / or Japanese regulatory authorities required Accomplished leader and manager, ideally having effectively managed regulatory affairs across emerging and larger companies Extensive knowledge of U.S. and International regulations including cGMP, GCP, GLP, ICH Experience managing consultants and contractors and ensuring the integrity and timeliness of their work Extensive knowledge and experience with eCTD regulatory filings / electronic submissions Strong understanding of drug development R&D, manufacturing, laboratory, and Quality systems Strong people management, collaboration and influencing skills Pragmatic thinker and problem-solver Thrive in a fast-paced, changing team environment and willing to be hands-on
POSITION SUMMARY
Position Title : Vice President, Regulatory Affairs
Reports to : CMO
Company Summary : Client is a stem cell therapeutic company developing an innovative platform technology for generating self-renewing blood stem cells. We have breakthrough potential to provide patients with rapid and broad access to HLA-compatible transgene-free blood stem cell therapies.
Client is committed to advancing science and enhancing the health and well-being of patients. This commitment, along with an exciting team culture, drives our efforts to develop an off the shelf stem cell therapeutic platform.
Position Summary : This is a newly created full-time position to continue the development and lead Client's Regulatory Affairs capabilities. The Vice President of Regulatory Affairs will be a member of the Leadership Team and work closely with the various members of Executive Leadership, Program Management, Technical Operations, and Nonclinical Development. The VP of Regulatory Affairs serves as a strategic partner for all functional areas in the company. Regulatory Affairs recommends development phase-appropriate strategies and tasks to guide development in compliance with regulation and regulatory guidance to maximize efficient and successfully leading to regulatory approval for the company’s off-the-shelf stem cell technology
Specific responsibilities include, but are not limited to :
- Develop and lead the global regulatory strategy for the company
- Build ‘fit to needs’ essential in-house regulatory capabilities
- Provide strategic and technical guidance on regulatory submissions
- Determine the Regulatory partnering and outsourcing strategy
- Lead the development of regulatory submissions for FDA, EMA, and other health authorities
- Ensure compliance with applicable standards, Regulatory regulations and guidance, and associated requirements for pharmaceutical development
- Proactively drive communications with health authorities
- In partnership with the head of Quality, serve as the primary regulatory liaison for site inspections, presentations, submissions, and compliance matters
- Guide the establishment of procedures and processes that ensure regulatory document compliance
- Oversee Regulatory Affairs product files to support compliance with all regulatory requirements
- Provide regulatory oversight and strategic and technical guidance in discussions with teams in support of due diligence for potential in-licensing activities, external collaborations, and acquisitions.
- Manage regulatory budgets and vendors
- Maintain knowledge of regulatory requirements and trends up to current date
- Occasional travel to the Boston office and other locations as required
Qualifications include :