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CMC Regulatory Affairs
1 week ago
Varite Short Hills, United StatesJob Description: · PREREQUISITES BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience, Sterile Injectable experience preferred. · Responsibilities will include, but a ...
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CMC 2 Regulatory affairs
2 days ago
Stellar Consulting Solutions, LLC Rahway, United StatesJob Description: · Job Title: Project Manager (CMC 2 Regulatory affairs) · Location: Rahway, NJ - Onsite · Pay rate: $50/hr on C2C OR $40 on W2 · Qualifications: · • Experience should be 4 to 7 years · • Bachelor's or master's degree required in science, engineering or related f ...
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CMC 2 Regulatory Affairs
4 days ago
Varite Short Hills, United StatesPay rate range: $40-43/hr. · Job Title: CMC 2 Regulatory affairs · Location: Rahway, NJ - Onsite · Responsibilities: · Well versed in performing CMC compliance activities including Gap Analysis; assessment for Annex 3 comparative table with reference EU Member States · Manag ...
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CMC 2 Regulatory Affairs
1 week ago
Varite Short Hills, United StatesJob Title: CMC 2 Regulatory affairs · Location: Rahway, NJ - Onsite · Responsibilities: · •Well versed in performing CMC compliance activities including Gap Analysis; assessment for Annex 3 comparative table with reference EU Member States · •Manage execution / authoring and ...
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CMC 2 Regulatory affairs
3 days ago
Katalyst Healthcares and Life Sciences Rahway, United StatesResponsibilities:Well versed in performing CMC compliance activities including Gap Analysis; assessment for Annex 3 comparative table with reference EU Member States. · Manage execution/authoring and review of CMC documentation (Module 1, 2 and 3/Part II) for life cycle managemen ...
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Senior CMC Regulatory Affairs
1 week ago
Cynet Systems Rahway, United StatesJob Description: · Pay Range $38hr - $43hr · Responsibilities: Well versed in performing CMC compliance activities including Gap Analysis; assessment for Annex 3 comparative table with reference Member States. · Manage execution / authoring and review of CMC documentation (Modul ...
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Regulatory Affairs CMC Animal Heath
1 week ago
Katalyst Healthcares and Life Sciences Rahway, United StatesResponsibilities: We are inviting applications for the role of CMC 2 Regulatory affairs. Responsibilities: · Well versed in performing CMC compliance activities including Gap Analysis and assessment for Annex 3 comparative table with reference EU Member States · Manage executio ...
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CMC 2 Regulatory Affairs
3 weeks ago
Varite Short Hills, United StatesPay rate range:$35-40/hr. · Job Description: · We are inviting applications for the role of CMC 2 Regulatory affairs. · Responsibilities: · " Well versed in performing CMC compliance activities including Gap Analysis; assessment for Annex 3 comparative table with reference EU Mem ...
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Associate Director US Regulatory Affairs CMC
1 week ago
Bayer CropScience Limited Hanover Twp, United StatesAt Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspe ...
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Manager, Global Regulatory Affairs CMC
2 weeks ago
Takeda Pharmaceutical Company Ltd Flushing, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's and . I further attest that all information I submit in my employment applica ...
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Director of Regulatory Affairs
3 days ago
X4 Life Sciences New Jersey, United StatesA long term consulting client of X4 Life Sciences is looking to add a Regulatory Affairs Subject Matter Expert to their division, · Our client are an expert in providing their clients with solutions to their most difficult drug development challenges as well as regulatory framewo ...
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Head of Regulatory Affairs
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EPM Scientific New Jersey, United StatesOur client, a clinical stage biotech company, is seeking an experienced and dynamic Head of Regulatory Affairs to join their growing team. This exciting opportunity offers the chance for a leader with clinical regulatory affairs experience to take on a hands-on leadership role. T ...
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Senior Director Regulatory Affairs
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SciPro New Jersey, United StatesOur client, an exciting and growing Biotech Company, is seeking a Regulatory Affairs professional at the Senior Director level. This role will lead the North America regulatory strategy and work extremely closely with the C-Suite leaders of the business. They are focused on Autoi ...
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Lead Regulatory Affairs Associate
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Navitas Life Sciences New Jersey, United StatesJob Title: Lead Regulatory Affairs · Work Location: US – EST, CST time zone. · Reports To: Practice Head - Regulatory · Job Description: · Develop and manage day-to-day operations using project management and planning tools, create and maintain detailed project timelines · Est ...
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Regulatory Affairs
4 days ago
AA2IT New York, United StatesJob Title: Regulatory Affairs - Animal Health · Location: Rahway, NJ - Onsite from day 1 · Pay Rate: $42/hr · Duration: 11 Months · We are inviting applications for the role of CMC 2 Regulatory affairs. · Responsibilities: · Well versed in performing CMC compliance activiti ...
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Associate Director/Director Strategy
1 week ago
EPM Scientific New York, United StatesThe Company is a Pharmaceutical company that has a great underdog story. They started as a generic company until they hired a new CEO who has turned the company around. They went from struggling to now 3x their stock. Their main focus is on women's health. · Join our team as a Di ...
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Senior Associate Director, Business Applications
7 hours ago
Columbia University New York, United States* Job Type: Officer of Administration · * Regular/Temporary: Regular · * Hours Per Week: 35 · * Salary Range: $86,000 - $98,000 · The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualif ...
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Axsome Therapeutics, Inc. New York, United StatesAxsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disor ...
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Director, Regulatory Affairs
1 week ago
Scismic Inc New York, United StatesJob Description · Job DescriptionScismic is supporting the growth of a late-stage, publicly traded biopharmaceutical company developing targeted radiotherapies to deliver cancer-killing radiation with cellular level precision to treat patients with high unmet medical needs. · The ...
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Compliance Coordinator
7 hours ago
Credit Agricole New York, United StatesSummary: · Â · Under the supervision of the FCS New-York, the Compliance Coordinator will work closely with the New York Compliance/ CPL team to support the implementation and execution of compliance initiatives, processes, and controls that manage compliance risks as well as act ...
Manager, Global Regulatory Affairs CMC - New York, United States - Takeda Pharmaceutical Company Ltd
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Description
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use.
I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Takeda Development Center Americas, Inc.
is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the following requirements:
Masters degree in Regulatory Affairs or related field plus 2 years of related experience
Prior experience must include:
Develop the regulatory submission strategies for products in commercial and development phase by working in close coordination with the quality, manufacturing and global regulatory teams; Ensure the response to health authority queries are provided in a timely and efficient manner by working with regulatory teams across different regions; Submit the compliance submissions such as annual reports (BLA), yearly biologic periodic reports and license renewals in a timely manner to ensure the marketed products are in compliance with Health Authority requirements; Provide regulatory assessments for change controls for various markets such as US FDA, EMA, Health Canada as well as liase with in-country regulatory representative to provide the assessments.
Up to 20% remote work allowed.Full time. $133,200.00 to $223,200.00 /year.
Apply on-line at and search for Req #R