- REMOTE
- Regulatory Affairs Specialist DS Process Expert with NDA filing experience.
- OpenThis is a remote position.
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Principal Regulatory Affairs Specialist
2 weeks ago
Philips Cambridge, United States**Job Title**: Principal Regulatory Affairs Specialist · **Principal Regulatory Affairs Specialist · - Software & Artificial Intelligence (U.S. Hub Based)** · The Principal Regulatory Affairs Specialist · - SW & AI will shape, lead and execute innovative regulatory strategies to ...
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Public Affairs Specialist
2 days ago
U.S. Department of Justice Boston, United StatesSummary · This job is open to · Career transition (CTAP, ICTAP, RPL) · Federal employees who meet the definition of a "surplus" or "displaced" employee. · Family of overseas employees · Family members of a federal employee or uniformed service member who is or was, working overse ...
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Research Affairs Specialist
1 week ago
Tufts University Boston, United StatesOverview: · Dental Research Administration (DRA) at TUSDM is the main research structure for all basic science and clinical projects at the Dental School. DRA is the liaison to the Office of the Vice Provost, Sponsored Accounting, IRB, IACUC, DLAM, Biosafety and all other offices ...
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Regulatory Affairs Specialist
3 weeks ago
Randstad North America, Inc. Cambridge, United StatesAs a core member of multiple new product development teams, the Regulatory Affairs Specialist will provide timely and valued regulatory guidance (written and / or verbal) by owning the following tasks: 1. Advise internal stakeholders (marketing, manu Regulatory Affairs, Specialis ...
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regulatory affairs specialist
1 week ago
Randstad Cambridge, United Statesregulatory affairs specialist (cambridge). · cambridge , massachusetts · posted 3 days ago · job details · summary · $65 - $80 per hour · contract · bachelor degree · category computer and mathematical occupations · reference · job details · job summary · Your Respons ...
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Regulatory affairs specialist
2 weeks ago
Randstad Cambridge, United Statesjob summary: · Your Responsibilities: · As a core member of multiple new product development teams, the Regulatory Affairs Specialist will provide timely and valued regulatory guidance (written and / or verbal) by owning the following tasks: · 1. Advise internal stakeholders (m ...
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Regulatory Affairs Specialist
3 days ago
Philips Cambridge, United States Full timeJOB DESCRIPTION Job Title · Regulatory Affairs Specialist Job Description · Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards cre ...
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Regulatory Affairs Specialist
3 weeks ago
Philips Cambridge, United States Full timeJob Title · Regulatory Affairs SpecialistJob Description · Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and faire ...
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Regulatory Affairs Specialist
1 week ago
Philips Cambridge, United States Full timeJOB DESCRIPTION Job Title · Regulatory Affairs Specialist Job Description · Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards cre ...
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Medical Affairs Specialist
1 week ago
Philips Cambridge, United States Full timeJob Title · Medical Affairs SpecialistJob Description · As a Medical Affairs Specialist, you will help to develop the Medical Office within HPM, contribute with clinical context in the whole lifecycle of our solutions and products. In close contact with selected customers and adv ...
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Regulatory Affairs Specialist
3 days ago
Philips Cambridge, United States Full timeJob Title · Regulatory Affairs SpecialistJob Description · Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and faire ...
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Regulatory Affairs Specialist I
1 week ago
Johnson & Johnson Raynham, United StatesDePuy Synthes, part of Johnson & Johnson MedTech, is recruiting for a **Regulatory Affairs Specialist I **to support our Spine business. _This role is located on-site in Raynham, MA and will work a Flex/Hybrid schedule with three days of on-site and two days of off-site work _. · ...
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Principal Regulatory Affairs Specialist
2 weeks ago
Philips Iberica SAU Cambridge, United StatesJob Title Principal Regulatory Affairs Specialist Job Description This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible ...
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Principal Regulatory Affairs Specialist
2 weeks ago
Philips Iberica SAU Cambridge, United StatesJob Title Principal Regulatory Affairs Specialist Job Description · This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possib ...
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Principal Regulatory Affairs Specialist
6 days ago
Philips Cambridge, United StatesJob Title Principal Regulatory Affairs Specialist Job Description · Principal Regulatory Affairs Specialist (U.S. Hub based) · Clinical Integration and Insight (CII) is changing the way healthcare is delivered at the point of care. Our Capsule Surveillance product is a clinical ...
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Principal Regulatory Affairs Specialist
3 weeks ago
Philips Cambridge, United StatesJob Title · Principal Regulatory Affairs Specialist Job Description · Principal Regulatory Affairs Specialist (U.S. Hub based) · Clinical Integration and Insight (CII) is changing the way healthcare is delivered at the point of care. Our Capsule Surveillance product is a clini ...
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Principal Regulatory Affairs Specialist
3 weeks ago
Philips Cambridge, United States Full timeJob Title · Principal Regulatory Affairs SpecialistJob Description · Principal Regulatory Affairs Specialist (U.S. Hub based) · Clinical Integration and Insight (CII) is changing the way healthcare is delivered at the point of care. Our Capsule Surveillance product is a clinical ...
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Principal Regulatory Affairs Specialist
3 weeks ago
Philips Cambridge, United StatesJob TitlePrincipal Regulatory Affairs Specialist · Job Description Principal Regulatory Affairs Specialist (U.S. Hub based) · Clinical Integration and Insight (CII) is changing the way healthcare is delivered at the point of care. Our Capsule Surveillance product is a clinical ...
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Principal Regulatory Affairs Specialist
3 weeks ago
Philips Cambridge, United StatesJob TitlePrincipal Regulatory Affairs SpecialistJob Description · Principal Regulatory Affairs Specialist (U.S. Hub based) · If your skills, experience, and qualifications match those in this job overview, do not delay your application. · Clinical Integration and Insight (CII) ...
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Principal Regulatory Affairs Specialist
3 weeks ago
Philips Cambridge, United StatesJob TitlePrincipal Regulatory Affairs SpecialistJob DescriptionPrincipal Regulatory Affairs Specialist- Software & Artificial Intelligence (U.S. Hub Based)The Principal Regulatory Affairs Specialist- SW & AI will shape, lead and execute innovative regulatory strategies to drive i ...
Senior Regulatory Affairs Specialist - Cambridge, United States - Validation Associates
Description
Contract Role:
Schedule: It will be on average 20 hours per week, preferably 4 hours a day M-F, but we can be flexible depending on the candidate.
May September (20 hours week)Contractor to support regulatory documentation review for the Drug Substance part of the NDA submission and incorporation of QbD elements in respective section of Module 3.An experienced API contractor to help with the review process for our NDA submission.
The external consultant should have extensive knowledge in synthetic peptide-based drugs, scale up experience, Regulatory CMC experience, and related areas to provide input in reviews/updates of the NDA Module 3 Quality sections 3.2.S.
The external consultant should also have a good NDA submission track record.Pay Rate