...Job title: CMC Regulatory Technical Writer II
Location: Bridgewater, NJ, Hybrid
Duration: 1 year
SHIFT SCHEDULE 1st shift... ...functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global locations or contract manufacturing...
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...therapies to help people build families, stay healthy, and stand up to the world's oldest enemy: disease.
As the Director, Regulatory Affairs CMC you will be responsible for developing and implementing regulatory strategies for US CMC activities throughout the product...
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...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...
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...Description:**
BeiGene is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory... ...for development of strategies, planning, drafting, and managing CMC-related regulatory submissions and HA interactions to meet the...
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CMC Regulatory Affairs Manager (Remote)
Contract: Thousand Oaks, California, US
Salary: $55.00 Per Hour
Job Code: 347260
End Date: 2024-05-19
Days Left: 25 days, 3 hours left
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...boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program leadership and develop CMC regulatory strategy for global vaccine programs in various...
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...have you in front of a live recruiter.
The Opportunity
Description
We're looking for an Associate Director Regulatory Affairs CMC , working in Pharmaceuticals and Medical Products industry in Cambridge, Massachusetts, United States .
Leads...
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...Learn more about our work, our culture, and what it's like to be a part of our team:
POSTION SUMMARY
Associate Director, CMC Regulatory Affairs is a hands-on and independent role requiring a strong individual who will provide strategic and operational support to...
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...Global Regulatory Affairs Lead (GRL)
Mission statements
The Global Regulatory Affairs Lead (GRL) is the fully accountable decision... ...development of multiple modalities; experience within regulatory CMC not directly applicable ?
Demonstrated expert regulatory...
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Reference Number: JO-2402-529329
Regulatory Specialist (CMC)
Rate: Negotiable
Job Type: Permanent
Location: Pomona
With a robust set... ...objectives.
Support the current head of Regulatory Affairs and file annual reports
Contribute to crafting regulatory...
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...4
Are you looking for a role where you will serve as a key strategic partner representing Global Regulatory activities? If so, this Director of Regulatory Affairs, CMC could be an exciting opportunity to explore. This role will provide strategic direction and guidance...
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...Job Description: · With minimal supervision, the Regulatory Affairs Expert-Medical Devices manages assigned regulatory tasks related to health authority notifications, submissions, and registrations regarding renewals and new products, and changes to products or sale...
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...conditions.
Could you be our next CSL Plasma Lead for Global Regulatory Affairs, Plasma? This position is located in our King of Prussia PA,... ...It is a Hybrid role. You will report to the VP, Head of GRA CMC.
You will provide strategic leadership and oversight in...
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...ways to continue making a difference, and new people to make a difference with.
The opportunity
The Senior Director, Regulatory Affairs CMC is responsible to manage and help develop regulatory strategies to support development of innovative products, as well as to...
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...important work with real-world impact, theres no better place to build your career.
Find your place at Pace
Join us as a CMC Regulatory Affairs Specialist, where youll put your love of science to work in the Scientific Insourcing Services department. Youll receive...
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...Who You Are
The Associate Director, Regulatory Affairs (CMC) works closely with the manufacturing department and individual program teams to ensure CMC compliance and promote overall regulatory success. The Associate Director, Regulatory Affairs (CMC) possesses strong...
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...CA
Contract Duration: 6-18 months
Rate: Negotiable
Responsibilities:
Excellent employment opportunity for a Regulatory Affairs CMC Associate in the Foster City, CA area. Bay area candidates ONLY
Provide Regulatory CMC support for biologic and small molecule...
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...Scope
To support business in maintaining regulatory compliance of existing manufactured... ...ensure continuous improvement.
Advising on CMC elements of variation / supplement... ...depth knowledge of the Global Regulatory Affairs environment Guidelines and legislation....
...registration of products while maintaining compliance with all regulatory requirements and commitments. Evaluates proposed regulations and... ...on the regulatory strategy for drug development including CMC, preclinical, clinical and/or commercial requirements at different...
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Software Guidance & Assistance, Inc., (SGA), is searching for a Regulatory Affairs Senior Manager for a FULL TIME assignment with one of our... ...and approved applications
Lead, guide and train the CMC team to ensure highly qualified personnel that is able to perform...
Full time
Local area
...health in the future.
**Objectives/Purpose of Job:**
+ The Regulatory Affairs Senior Specialist handles US regulatory development aspects... ...including Development, Promotion and Advertising, Labeling, CMC, Commercialization and Operations.
+ Knowledge of domestic...
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Remote Regulatory Affairs Manager
Contract: Thousand Oaks , California, US
Salary... ...Act as a point of contact between regulatory representatives/CMC and publishing teams
Ensure regulatory compliance with SOPs...
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...Job 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 activities...
Worldwide
...Accountable to the asset GRL and/or the Global Regulatory TG Head for development and delivery of... ...other GRA teams such as non-clinical, CMC, Labelling and AdPromo through the... ...strategy or related experience.
* Regulatory affairs experience in at least one therapeutic area...
Local area
...Role: Regulatory Affairs Associate
Location: Alameda, CA
Duration: 10+ Months
Shift Timings: 8 am to 5 pm
Job Description:
Experience in a medical device or similarly regulated industry
Ability to schedule and organize multiple projects
BS Engineering...
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...We have an exciting opportunity at Ameriprise as a Regulatory Affairs Analyst! This position is part of a team that provides day-to-day operational support to the Regulatory Affairs team in managing regulatory exams, inquiries and internal investigations. This includes...
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...excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Manager, Regulatory Affairs in Boca Raton, FL !
The Manager, Regulatory Affairs supervises and participates in planning, preparing and evaluating regulatory...
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...Regulatory Affairs Specialist
Newark, DE, United States
Hologic is seeking a Regulatory Affairs Specialist to join our expanding Innovation Center located in Newark, DE.
What to Expect:
The Regulatory Affairs Specialist is expected to perform the coordination...
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...Job Description:
The Regulatory Affairs Specialist will be responsible for establishing, coordinating, and executing user experience / design validations and related communications in support of Ormco Product Development. This position manages the design, study preparation...
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Description
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Regulatory Affairs Coordinator
Contract: Sylmar, California, US
Salary: $40.00 Per Hour
Job Code: 348575
End Date: 2024-05-22
Days Left: 28 days, 3 hours left
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