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Senior Manager of Regulatory Affairs

Beacon Hill Staffing
Noblesville, IN
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To Apply for this Job Click Here Summary of Position The Senior Manager of ...
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Summary
About the job:
Regulatory Affairs is responsible for Regulatory Affairs dossiers and associated regulatory affairs activities in the US. The responsibilities include, yet are not limited to, defining and or authoring compliant content for new and existing dossiers, implementing and managing tracking systems, and preparation of electronic submissions. The main focus of this position will be on new submissions associated with new chemical entity (NCE) as well as products already in non-clinical and/or clinical studies. This position...
Location:
Noblesville, IN
Job Type:
Full-Time
Contract
Occupation:
Regulatory Affairs Managers
Career Level / Education:
High school diploma or equivalent
Salary:
Six Figure Jobs (more than $100K)
Certifications / Licenses:
N/A
Workkeys
Applied Math
4
Graphic Literacy
4
Workplace Documents
5
apply
Detailed Job Information

Senior Manager Regulatory Affairs CMC

Beacon Hill Staffing
Noblesville, IN
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To Apply for this Job Click Here Summary of Position The Senior Manager of ...
Details
Summary
About the job:
Regulatory Affairs is responsible for Regulatory Affairs dossiers and associated regulatory affairs activities in the US. The responsibilities include, yet are not limited to, defining and or authoring compliant content for new and existing dossiers, implementing and managing tracking systems, and preparation of electronic submissions. This position requires a highly skilled and experienced individual capable of navigating the complex regulatory landscape related to CMC. The main focus of this position will be on new...
Location:
Noblesville, IN
Job Type:
Full-Time
Contract
Occupation:
Regulatory Affairs Managers
Career Level / Education:
High school diploma or equivalent
Salary:
Six Figure Jobs (more than $100K)
Certifications / Licenses:
N/A
Workkeys
Applied Math
4
Graphic Literacy
4
Workplace Documents
5
apply
Detailed Job Information

Director, Regulatory Affairs

Advent Global Solutions, Inc.
Located in Ohio
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Job Details Quality Assurance Compliance Specialist 12 months Summary of the ...
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About the job:
Position: We are seeking a Quality Assurance Compliance Specialist III to join our Quality department in Gaithersburg, MD. The Specialist IV will primarily be responsible for quality oversight and review of data supporting product development and GMP activities. The candidate will also be responsible for managing the compliance system for the Novavax network, which includes establishing compliance procedures and developing organizational strategies to ensure the company complies with regulatory requirements of...
Location:
Located in Ohio
Job Type:
Full-Time
Contract
Occupation:
Regulatory Affairs Managers
Career Level / Education:
High school diploma or equivalent
Salary:
Six Figure Jobs (more than $100K)
Certifications / Licenses:
Good Laboratory Practices certifications
Workkeys
Applied Math
4
Graphic Literacy
4
Workplace Documents
5
apply
Detailed Job Information

Senior Regulatory Strategy Consultant (Contract)

ReCode Therapeutics
Menlo Park, CA
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Job Details Who We Are: ReCode Therapeutics is a clinical-stage genetic ...
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About the job:
medicines company using precision delivery to power the next wave of mRNA and gene correction therapeutics. ReCode’s proprietary Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform enables highly precise and targeted delivery of genetic medicines directly to the organs, tissues and cells implicated in disease, enabling improved efficacy and potency. ReCode’s lead programs include RCT1100 for the treatment of primary ciliary dyskinesia caused by pathogenic mutations in the DNAI1 gene, and RCT2100 for the...
Location:
Menlo Park, CA
Job Type:
Full-Time
Contract
Occupation:
Regulatory Affairs Managers
Career Level / Education:
High school diploma or equivalent
Salary:
Six Figure Jobs (more than $100K)
Certifications / Licenses:
Petroleum Safety Training
Workkeys
Applied Math
4
Graphic Literacy
4
Workplace Documents
5
apply
Detailed Job Information

CMC Senior Manager

TSR Consulting Services, Inc.
New Brunswick, NJ
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CMC Senior Manager Job Description Location: New Brunswick, New Jersey Type: ...
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About the job:
Contract Job #79163 Our client, a leading pharmaceutical company, is hiring a CMC Senior Manager on a contract basis. Job ID #: 79163 Work Location: New Brunswick, NJ Knowledge/Skills/Education: - BS/BA degree in Scientific Discipline (master’s preferred) with 5 years in the pharmaceutical industry, preferably with 3 years CMC regulatory experience. - Experience with CMC regulatory documents (global registrations, including NDAs, MAAs and others, responses and supplements/variations). - Knowledge of FDA, EMA and/or...
Location:
New Brunswick, NJ
Job Type:
Full-Time
Contract
Occupation:
Regulatory Affairs Managers
Career Level / Education:
High school diploma or equivalent
Salary:
Six Figure Jobs (more than $100K)
Certifications / Licenses:
N/A
Workkeys
Applied Math
4
Graphic Literacy
4
Workplace Documents
5
apply
Detailed Job Information

Regulatory Manager (pre market) - 8 month Maternity Cover Contract

CMR Surgical
Cambridge, MA
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Job Description We are looking for an experienced Regulatory Affairs Manager ...
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About the job:
for an upcoming maternity cover contract for our team in Cambridge. This role will oversee all aspects of the regulatory affairs team and associated pre- and post-market regulatory tasks for new and modified products. This is a hybrid role, with an expected start date in early May for 8 months. The position will require the successful candidate to come into the office approximately 5 days a month. About CMR Surgical CMR is an exciting and evolving company to be joining right now. Our commitment to our goal of...
Location:
Cambridge, MA
Job Type:
Full-Time
Contract
Occupation:
Regulatory Affairs Managers
Career Level / Education:
High school diploma or equivalent
Salary:
Six Figure Jobs (more than $100K)
Certifications / Licenses:
N/A
Workkeys
Applied Math
4
Graphic Literacy
4
Workplace Documents
5
apply
Detailed Job Information

Global Regulatory CMC Manager

American Cybersystems, Inc.
Summit, NJ
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Job Description: Innova Solutions is immediately hiring a Global Regulatory ...
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About the job:
CMC Manager Job Global Regulatory CMC Manager Position type: Full-time Contract Duration: 09 Months Location: Summit, or Lawrenceville NJ Onsite As a Global Regulatory CMC Manager, you will: - Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings. - Prepare and review CMC submission documents, registration dossiers, health authority briefing...
Location:
Summit, NJ
Job Type:
Full-Time
Contract
Occupation:
Regulatory Affairs Managers
Career Level / Education:
High school diploma or equivalent
Salary:
Six Figure Jobs (more than $100K)
Certifications / Licenses:
N/A
Workkeys
Applied Math
4
Graphic Literacy
4
Workplace Documents
5
apply
Detailed Job Information

Sr. Manager, Regulatory Project Management

ProClinical
Located in Ohio
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Senior Manager, Regulatory Project Management - Contract - Cambridge, MA ...
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Summary
About the job:
Proclinical is seeking a Sr. Manager, Regulatory Project Manager for a leading pharmaceutical company. This is a contract position located in Cambridge, MA. Primary Responsibilities: The role is focused on R&D project management for late-stage global regulatory filings. The successful candidate will be responsible for developing and optimizing detailed regulatory project plans and timelines, maintaining real-time filing timelines, and facilitating critical filing team meetings. This role is crucial in ensuring that...
Location:
Located in Ohio
Job Type:
Full-Time
Contract
Occupation:
Regulatory Affairs Managers
Career Level / Education:
High school diploma or equivalent
Salary:
Six Figure Jobs (more than $100K)
Certifications / Licenses:
N/A
Workkeys
Applied Math
4
Graphic Literacy
4
Workplace Documents
5
apply
Detailed Job Information

Global Regulatory CMC Manager

American Cybersystems, Inc.
Princeton, NJ
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Job Description: Innova Solutions is immediately hiring for an Global ...
Details
Summary
About the job:
Regulatory CMC Manager Tittle: Global Regulatory CMC Manager Duration: 9 months Contract Location: Lawrenceville , NJ (onsite) Pay Range*: $88.57 - $89.85 per hour. As a(n) Global Regulatory CMC Manager you will: Job Description: - Participate in the development of the CMC regulatory strategy for biologics submissions. These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings. - Prepare and review CMC submission documents, registration dossiers, health authority briefing...
Location:
Princeton, NJ
Job Type:
Full-Time
Contract
Occupation:
Regulatory Affairs Managers
Career Level / Education:
High school diploma or equivalent
Salary:
Six Figure Jobs (more than $100K)
Certifications / Licenses:
N/A
Workkeys
Applied Math
4
Graphic Literacy
4
Workplace Documents
5
apply
Detailed Job Information

Regulatory Affairs Manager II

The Ascent Services Group
Located in Ohio
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Is Open : true Is Deleted : false Employment Type : Contract Date Last ...
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Summary
About the job:
Published : 1710859120410 Public Description : Hello, Innova Solutions is immediately hiring for a Regulatory Operations Manager – Remote Job Type: Full time, Contract Duration: 12 months contract Location: Chicago, IL - 60614 As a Regulatory Operations Manager – Remote your responsibilities: Job Description: The candidate will work as a liaison between stakeholders and vendors to derive information for the creation and editing of ECTD submissions, Acting as a quality control person on ECTD components, they will check the...
Location:
Located in Ohio
Job Type:
Full-Time
Contract
Occupation:
Regulatory Affairs Managers
Career Level / Education:
High school diploma or equivalent
Salary:
Six Figure Jobs (more than $100K)
Certifications / Licenses:
N/A
Workkeys
Applied Math
4
Graphic Literacy
4
Workplace Documents
5
apply
Detailed Job Information
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Job Type: Contract
Salary: Six Figures Jobs ($100K+)
Occupation: Regulatory Affairs Managers
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