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Manager/Senior Manager, CMC Regulatory Affairs

Alkermes, Inc.
Waltham, MA
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External Description Str : Great Science. Deep Compassion. Real Impact. ...
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Summary
About the job:
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. Chemistry,...
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

Manager, Global Regulatory Affairs

Biogen
Cambridge, MA
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Manager, Global Regulatory Affairs About This Role The Global Regulatory ...
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Summary
About the job:
Affairs Manager, works closely with Global and Regional Regulatory Leads providing support for a variety of regulatory activities for development and marketed products. You are a member of the Regulatory Project Team for assigned programs and work with direction from regional or global regulatory leads to accomplish a variety of regulatory activities and deliverables including interfacing with the regulatory operations team. What You’ll Do - Working closely with, and with direction from regional or global regulatory...
Location:
Cambridge, 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 Manager, Regulatory CMC Lead

Biogen
Cambridge, MA
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About This Role This role is responsible for Regulatory CMC expertise into ...
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Summary
About the job:
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 delegated. Depending...
Location:
Cambridge, 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 Science & Policy, NA

Sanofi
Washington, DC
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Sanofi Regulatory Science and Policy, Region North America team is hiring a ...
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About the job:
motivated individual to help advance regulatory science and strategically engage in regulatory policy efforts. Reporting through Region North America within Global Regulatory Affairs (GRA), the candidate will work collaboratively with both internal and external stakeholders to identify areas important to Sanofi and pharmaceutical business, development of policy positions, creation and execution of advocacy strategies to achieve policy goals to have a positive impact on the environment advise internal stakeholders on...
Location:
Washington, DC
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
5
Workplace Documents
6
apply
Detailed Job Information

Associate Director Regulatory Labeling Strategist

Zenith LifeScience
Montgomery Village, MD
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The Labelling Strategy Associate Director provides regulatory labelling ...
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About the job:
expertise, typically for more complex drug projects, to the Global Regulatory Submission Team (GRST)/Global Regulatory Execution Team (GRET), and cross functional Product Labelling Teams (PLT). This individual leads the development/implementation of the labelling strategy and maintenance of Core Product Information and United States (US) /European Union (EU) Market Product information (MPI) for assigned client (Client) marketed or pipeline products. Responsibilities : Ensures that the labelling process is followed through...
Location:
Montgomery Village, MD
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

Manager - Regulatory Affairs - Therapeutic Area

NOVO Nordisk
Plainsboro, NJ
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About the Department The Clinical, Medical and Regulatory (CMR) department ...
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Summary
About the job:
at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better...
Location:
Plainsboro, NJ
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 of Regional Regulatory Vaccines Lead

CSL Behring
Summit, NJ
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Job Details CSL Behring is a global biotechnology leader, guided by a ...
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Summary
About the job:
promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn...
Location:
Summit, NJ
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, Global Labeling Lead

Pfizer
La Jolla, CA
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Why Patients Need You We're looking to bring medicines to the world faster ...
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Summary
About the job:
and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines . Job Summary The Global Labeling Lead (GLL) has overall accountability for the initial creation and relevant updates to labeling documents for their assigned products. This includes guiding the...
Location:
La Jolla, 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:
N/A
Workkeys
Applied Math
4
Graphic Literacy
4
Workplace Documents
5
apply
Detailed Job Information

SVP, Global Regulatory Affairs

Dyne Therapeutics
Waltham, MA
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Job Details Company Overview: Dyne Therapeutics is a clinical-stage muscle ...
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Summary
About the job:
disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy...
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

Head of Regulatory Affairs Policy & Regulatory Intelligence

Amgen
Located in Ohio
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HOW MIGHT YOU DEFY IMAGINATION? At Amgen, every challenge is an opportunity. ...
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Summary
About the job:
And every opportunity brings the potential to change lives. Our shared mission—to serve patients—has driven our status as one of the world’s preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses. Head of Regulatory Affairs Policy & Intelligence Live What You Will Do Let’s do this. Let’s change the world....
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
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