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Product Regulatory Compliance Manager

FUJIFILM
North Kingstown, RI
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Who We Are FUJIFILM Electronic Materials, U.S.A., Inc., is a global leader ...
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About the job:
in chemical solutions which enable the semiconductor industry and the digital universe. We have an exciting opportunity at our North Kingstown, Rhode Island facility for a Product Regulatory Compliance Manager ! With state-of-the-art manufacturing facilities in the U.S., Europe, Taiwan, China, Korea and Japan, local sales offices throughout the world and on-site applications support, FUJIFILM Electronic Materials supplies the world's top tier semiconductor manufacturers with a broad array of products and services used...
Location:
North Kingstown, RI
Job Type:
Full-Time
Permanent
Occupation:
Regulatory Affairs Managers
Career Level / Education:
High school diploma or equivalent
Salary:
Six Figure Jobs (more than $100K)
Certifications / Licenses:
EPA certification
Workkeys
Applied Math
4
Graphic Literacy
4
Workplace Documents
5
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Senior Manager, Regulatory Affairs

Biogen
Located in Ohio
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Job Description Manager, Regulatory Affairs About This Role The Manager, ...
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About the job:
Regulatory Affairs, works closely with the US Regulatory Lead and participates on cross-functional project teams and present the US regulatory position to senior management governance committees as needed. This role is also open to Hybrid- RTP (Research Triangle Park location). What You’ll Do - Provide support and responsible for product labeling, FDA Requests for Information (safety-related), Type C Meeting requests, Post-Marketing Annual Reports, IND and Orphan Drug Annual Reports, USAN submissions, Proprietary name...
Location:
Located in Ohio
Job Type:
Full-Time
Permanent
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 CMC Lead

Biogen
Located in Ohio
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Job Description About This Role This role is responsible for Regulatory CMC ...
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About the job:
expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Responsibilities include preparation and compilation of submission/documentation for specific antisense oligonucleotide projects working as or working with the Regulatory CMC Lead and key stakeholders, primary contact for affiliates on Regulatory CMC activities in the assigned regions and managing of routine and non-routine Health Authority interactions as...
Location:
Located in Ohio
Job Type:
Full-Time
Permanent
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

Associate Director, Global Regulatory Affairs Labeling

Incyte Corporation
Wilmington, DE
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Description : Overview Incyte is a biopharmaceutical company focused on the ...
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discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value. The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules. Job Summary The Associate Director, Global...
Location:
Wilmington, DE
Job Type:
Full-Time
Permanent
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 - Content Excellence and Marketing Agency Optimization

MERCK & COMPANY
New York, NY
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Job Description Under the general direction of the Vice President, Chief ...
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Safety Officer, and Clinical Safety and Risk Management (CSRM) TA Lead, the Executive Director for CSRM will be responsible for overall clinical risk management and safety surveillance of assigned investigational products. Additionally, the incumbent will provide senior safety leadership for assigned marketed products across our company's portfolio of products. The Executive Director will drive delivery of safety input to clinical development of oncology assets. This includes all aspects of safety data evaluation,...
Location:
New York, NY
Job Type:
Full-Time
Permanent
Occupation:
Regulatory Affairs Managers
Career Level / Education:
High school diploma or equivalent
Salary:
Six Figure Jobs (more than $100K)
Certifications / Licenses:
HAZMAT
Driver's License
Board Certified
Workkeys
Applied Math
4
Graphic Literacy
4
Workplace Documents
5
apply
Detailed Job Information

Senior Director/Director, Global Regulatory Affairs Early Respiratory & Immunology

Astra Zeneca
Boston, MA
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Do you have leadership skills and an in depth knowledge within Regulatory ...
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About the job:
Affairs? Do you want to work on innovative projects of importance for our early Respiratory and Immunology portfolio? At AstraZeneca, we aspire to be pioneers in science, leading in our disease areas and truly transform patient outcomes. This means our people are here to win, we give you a breadth of opportunities to be curious and do groundbreaking, unique work that has significant impact on science, medicines and patients. The Global Regulatory Affairs Therapeutic area team that you will belong to is a strategic...
Location:
Boston, MA
Job Type:
Full-Time
Permanent
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, Late Cardiovascular, Renal and Metabolism

Astra Zeneca
Boston, MA
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Are you passionate about science and experienced within regulatory affairs ...
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and drug development ? Do you possess strategic and operational leadership skills? Then, join us at Cardiovascular, Renal or Metabolism (CVRM) regulatory affairs to get involved in the global regulatory strategies and support the research, development and commercialization of our products across the portfolio! AstraZeneca’s pipeline of innovative medicines is consistently growing within Cardiovascular, Renal and Metabolism (CVRM). Within CVRM Regulatory Affairs we take innovative regulatory approaches to bring these...
Location:
Boston, MA
Job Type:
Full-Time
Permanent
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 Director, Regulatory Affairs

Alkermes, Inc.
Waltham, MA
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External Description Str : The Opportunity We are seeking an individual who ...
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About the job:
is talented, motivated, and passionate about science to join our Regulatory Strategy team. As Senior Director of Regulatory Affairs, the successful candidate will play an important role in guiding new products into the clinic and setting the stage for registration. The individual in this role will serve as a Regulatory Lead for pipeline drug development programs and marketed products, and will be responsible for developing, implementing, and driving global Regulatory strategies. The ideal candidate will have a strong...
Location:
Waltham, MA
Job Type:
Full-Time
Permanent
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, CMC Regulatory Affairs

Alkermes, Inc.
Waltham, MA
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External Description Str : Overview: Great Science. Deep Compassion. Real ...
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About the job:
Impact. Alkermes is offering exciting opportunities through our commitment to work together to help improve the lives of people living with serious mental illness, and addiction. We are inspired by the courage and determination of individuals living with complicated and often difficult-to-treat diseases. We have a portfolio of proprietary marketed products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, and neurological disorders....
Location:
Waltham, MA
Job Type:
Full-Time
Permanent
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

Alameda Health System
Oakland, CA
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Summary SUMMARY: Plans, coordinates, monitors compliance with federal, state ...
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Summary
About the job:
and local regulations; manages accreditation activities necessary for maintaining required accreditation; manages requirements for certifications and licensure from various organizations, such as Joint Commission (JC), California Department of Public Health (CDPH), CMS, OSHPD, CDPH Lab Field Services, CDPH Radiologic Health Branch, etc.; prioritizes projects, coordinates action plans, and monitors/analyzes results for accreditation projects, consistent with the organization's strategic goals. DUTIES & ESSENTIAL JOB...
Location:
Oakland, CA
Job Type:
Full-Time
Permanent
Occupation:
Regulatory Affairs Managers
Career Level / Education:
High school diploma or equivalent
Salary:
Six Figure Jobs (more than $100K)
Certifications / Licenses:
Six Sigma certification
Certified Professional in Healthcare Quality
Workkeys
Applied Math
4
Graphic Literacy
4
Workplace Documents
5
apply
Detailed Job Information
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