Regulatory affairs Jobs in Cambridge, MA
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Regulatory affairs • cambridge ma
Last updated: 18 hours 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: 29 days ago
We are proud to partner with an innovative biotechnology company in the search for a.Senior Director, Regulatory Affairs.
This fully remote role (US or Canada) will lead regulatory strategy, executi...Show moreLast updated: 3 days ago
Essential Functions : Responsible to participate on design and risk management teams in the Hemostasis group as the Regulatory representative and provide guidance on domestic and international requir...Show moreLast updated: 19 hours ago
Newleos Therapeutics is a clinical stage neuroscience company co-founded by Longwood Fund and seasoned leaders in CNS drug development.
Newleos’ clinical-stage pipeline was in-licensed from Roche an...Show moreLast updated: 3 days ago
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases.We develop medicines for p...Show moreLast updated: 30+ days ago
Genesis is dedicated to giving patients with organ failure a second chance at life by harnessing the power of genome engineering to create safe, effective, and readily available solutions.Reporting...Show moreLast updated: 7 days ago
Regulatory Affairs Director, Global Regulatory Strategy.The Regulatory Affairs Director, Global Regulatory Strategy will be responsible for the development and implementation of global regulatory s...Show moreLast updated: 30+ days ago
Regulatory Affairs Manager, CMC - Biologics (Phase 3 Asset | Advanced Modality).Boston area (hybrid, flexible travel).I'm currently searching for a Regulatory Affairs professional looking to take o...Show moreLast updated: 7 days ago
Principal Regulatory Affairs Specialist.The Principal Regulatory Affairs Specialist will develop and execute the regulatory strategy for new product development, design changes, and field safety co...Show moreLast updated: 18 hours ago
Reporting to the Director of Regulatory Affairs, the Regulatory Affairs Manager is responsible for executing regulatory strategies, ensuring compliance with global regulations and leading the proce...Show moreLast updated: 6 days ago
Principal Regulatory Affairs Specialist.The Principal Regulatory Affairs Specialist will develop and execute the regulatory strategy for new product development, design changes, and field safety co...Show moreLast updated: 1 day ago
Lantheus (NASDAQ : LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcome...Show moreLast updated: 30+ days ago
Medical Device Company – Commercial Stage.This position will collaborate closely with.Quality, R&D, and senior leadership.
Class II and Class III medical devices.Health Canada, TGA, ANVISA, PMDA...Show moreLast updated: 8 days ago
Regulatory Affairs Strategy Lead.Are you a strategic thinker with a passion for navigating the complex world of global regulatory affairs? Do you thrive in cross-functional environments and love tr...Show moreLast updated: 7 days ago
Regulatory Labelling Documentation.Support the creation and maintenance of assigned labelling projects to enable worldwide regulatory submissions.
Independently prepare and maintain the Tracking She...Show moreLast updated: 30+ days ago
Regulatory Affairs Director, Global Regulatory Strategy.The Regulatory Affairs Director, Global Regulatory Strategy will be responsible for the development and implementation of global regulatory s...Show moreLast updated: 30+ days ago
A clinical-stage neuroscience biotechnology company is seeking a seasoned regulatory leader to join its team.The organization is advancing a pipeline of small molecules targeting novel mechanisms a...Show moreLast updated: 3 days ago
The Associate Director, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval...Show moreLast updated: 3 days ago
The Associate Director, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval...Show moreLast updated: 21 hours ago
Vice President Regulatory Affairs
Clinical Dynamix, Inc.Cambridge, MA, USFull-time
Quick Apply
Head of Regulatory Affairs
RPM ReSearchBoston, Massachusetts, United StatesFull-time
- New!
Regulatory Affairs Specialist II
Werfen N.A.Bedford, MA, USFull-time
Vice President Regulatory Affairs
Newleos TherapeuticsBoston, Massachusetts, United StatesFull-time
- Promoted
Associate Director, Regulatory Affairs
Rhythm PharmaceuticalsBoston, MA, USFull-time
- Promoted
Director, Regulatory Affairs
eGenesisCambridge, MA, USFull-time
- Promoted
Regulatory Affairs Director, Global Regulatory Strategy
AstraZenecaJamaica Plain, MA, USFull-time
- Promoted
Regulatory Affairs Manager, CMC
Vivid ResourcingBoston, MA, USPart-time
- Promoted
- New!
Principal Regulatory Affairs Specialist
Massachusetts StaffingCambridge, MA, USFull-time
- Promoted
Regulatory Affairs Manager
DeepHealthBoston, MA, United StatesFull-time
- Promoted
Principal Regulatory Affairs Specialist
PhilipsCambridge, MA, USFull-time
- Promoted
Director, Regulatory Affairs - Strategy
LantheusBedford, MA, United StatesFull-time
- Promoted
Regulatory Affairs Manager
PragmaticBedford, MA, USFull-time
- Promoted
Senior Regulatory Affairs Consultant - Regulatory Lead
Boston StaffingBoston, MA, USFull-time
- Promoted
Regulatory Affairs Coordinator
Katalyst Healthcares & Life SciencesBoston, MA, USFull-time
- Promoted
Regulatory Affairs Director, Global Regulatory Strategy
Alexion PharmaceuticalsBoston, MA, USFull-time
Vice President Regulatory Affairs
GQRBoston, Massachusetts, United StatesFull-time
Assoc Dir, Regulatory Affairs
Foundation Medicine, Inc.Boston, Massachusetts, United StatesFull-time
- New!
Assoc Dir, Regulatory Affairs
Foundation Medical StaffingBoston, MA, USFull-time
The average salary range is between $ 113,100 and $ 200,200 year , with the average salary hovering around $ 159,713 year .
- hospital (from $ 40,911 to $ 245,000 year)
- data science (from $ 83,200 to $ 240,000 year)
- statistics (from $ 158,000 to $ 227,700 year)
- software engineering manager (from $ 110,800 to $ 226,898 year)
- medical office (from $ 36,563 to $ 225,000 year)
- director of software engineering (from $ 166,875 to $ 225,000 year)
- engineering manager (from $ 106,382 to $ 225,000 year)
- healthcare analyst (from $ 77,288 to $ 222,251 year)
- veterinarian (from $ 83,200 to $ 216,500 year)
- Boston, MA (from $ 125,771 to $ 200,600 year)
- Cambridge, MA (from $ 113,100 to $ 200,200 year)
- Atlanta, GA (from $ 87,750 to $ 195,950 year)
- San Francisco, CA (from $ 103,208 to $ 195,773 year)
- San Jose, CA (from $ 104,003 to $ 194,780 year)
- San Diego, CA (from $ 104,546 to $ 193,259 year)
- New York, NY (from $ 90,142 to $ 189,903 year)
- Seattle, WA (from $ 95,000 to $ 185,000 year)
- Pittsburgh, PA (from $ 49,920 to $ 177,310 year)
- Houston, TX (from $ 69,257 to $ 170,000 year)
The average salary range is between $ 74,006 and $ 170,765 year , with the average salary hovering around $ 105,135 year .
Vice President Regulatory Affairs
Clinical Dynamix, Inc.Cambridge, MA, US29 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 :