Talent.com
Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

VirtualVocationsLowell, Massachusetts, United States
job_description.job_card.30_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

A company is looking for a Senior Regulatory Affairs Specialist (Remote).

Key Responsibilities

Author and compile CMC sections of regulatory applications, including INDs, IMPDs, CTAs, amendments, and annual reports

Draft and maintain high-quality CMC regulatory documents such as Module 2 and 3 summaries, stability reports, and comparability protocols

Develop CMC regulatory strategies to support clinical trial initiation and advancement

Required Qualifications

B.A., B.S., M.S., or Ph.D. in biochemistry, chemistry, biology, or a related pharmaceutical field

Minimum of 10+ years of experience in CMC / regulatory affairs

Hands-on experience authoring and compiling CMC sections of regulatory filings

Strong knowledge of global CMC clinical regulatory requirements and guidelines, including FDA, EMA, and ICH

Proficiency with regulatory document management systems

serp_jobs.job_alerts.create_a_job

Regulatory Specialist • Lowell, Massachusetts, United States

Job_description.internal_linking.related_jobs
  • serp_jobs.job_card.promoted
Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

VirtualVocationsManchester, New Hampshire, United States
serp_jobs.job_card.full_time
A company is looking for a Senior Regulatory Affairs Specialist (Remote).Key Responsibilities Author and compile CMC sections of regulatory applications, including INDs, IMPDs, CTAs, amendments, ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
Regulatory Diagnostics Manager / Senior Regulatory Diagnostics Manager

Regulatory Diagnostics Manager / Senior Regulatory Diagnostics Manager

Novartis Group CompaniesCambridge, MA, United States
serp_jobs.job_card.full_time
The Regulatory Diagnostics Manager (RDM) for Precision Diagnostics is responsible for implementation of strategic plans for development of diagnostics, including companion diagnostics (CDx), as the...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
Regulatory Affairs Specialist

Regulatory Affairs Specialist

LumafieldBoston, MA, US
serp_jobs.job_card.full_time
Lumafield was founded in 2019 to upgrade manufacturing.We are engineers with deep experience across the product development cycle, from initial ideas to shipping hardware, across industries and spe...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
Regulatory Affairs Specialist - Abiomed, Inc.

Regulatory Affairs Specialist - Abiomed, Inc.

J&J Family of CompaniesDanvers, MA, US
serp_jobs.job_card.full_time
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving a...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
  • serp_jobs.job_card.promoted
Senior Director, Regulatory Affairs

Senior Director, Regulatory Affairs

eGenesisCambridge, MA, US
serp_jobs.job_card.full_time
Senior Director, Regulatory Affairs.Reporting to the Senior Vice President of Development and based in our Cambridge, MA office, the Director / Senior Director of Regulatory Affairs is responsible fo...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
  • serp_jobs.job_card.promoted
Senior Regulatory Affairs Specialist - Urology

Senior Regulatory Affairs Specialist - Urology

Boston ScientificMarlborough, MA, US
serp_jobs.job_card.full_time
Senior Regulatory Affairs Specialist - Urology.Onsite Location(s) : Irvine, CA, US, 92602.Additional Location(s) : US-CA-Irvine. US-CA-Valencia; US-MA-Marlborough; US-MN-Maple Grove.Diversity - Innov...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
Senior Treasury Regulatory Relations Associate

Senior Treasury Regulatory Relations Associate

Santander Holdings USA IncBoston, MA, United States
serp_jobs.job_card.full_time
Senior Treasury Regulatory Relations Associate.Country : United States of America.Santander is a global leader and innovator in the financial services industry. We believe that our employees are our ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
  • serp_jobs.job_card.promoted
Senior Regulatory Affairs Specialist - Abiomed, Inc.

Senior Regulatory Affairs Specialist - Abiomed, Inc.

J&J Family of CompaniesDanvers, MA, US
serp_jobs.job_card.full_time
Senior Regulatory Affairs Specialist.Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
  • serp_jobs.job_card.promoted
Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

IPG PhotonicsMarlborough, MA, US
serp_jobs.job_card.full_time
IPG Medical Corporation is focused on developing next-generation medical products based on its state-of-the-art technology. Headquartered in Marlborough, MA, we aspire to work together with our empl...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
Regulatory Affairs Specialist

Regulatory Affairs Specialist

VirtualVocationsWorcester, Massachusetts, United States
serp_jobs.job_card.full_time
A company is looking for a Regulatory CMC Author.Key Responsibilities Lead the preparation, submission, and maintenance of regulatory documents for clinical trials and drug registration Provide ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
Regulatory Affairs Specialist I

Regulatory Affairs Specialist I

Katalyst Healthcares & Life SciencesWorcester, MA, US
serp_jobs.job_card.full_time
Responsibilities : You are responsible for managing our Regulatory Affairs for the US facility and fulfill US Agent responsibilities for all foreign Siegfried sites. Additionally, you will be managin...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
  • serp_jobs.job_card.promoted
Sr. Director, Regulatory Affairs

Sr. Director, Regulatory Affairs

Akebia TherapeuticsCambridge, MA, United States
serp_jobs.job_card.full_time
Nearly 37 million Americans are currently affected by Chronic Kidney Disease.At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of e...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
Senior Director Global Regulatory Affairs – Global Regulatory Lead – Neuroscience

Senior Director Global Regulatory Affairs – Global Regulatory Lead – Neuroscience

Takeda PharmaceuticalBoston, MA, United States
serp_jobs.job_card.full_time
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that.I provide in my application will be processed in line with.I further attest th...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
  • serp_jobs.job_card.promoted
Senior Regulatory Affairs Specialist (IVD Exp. supporting US / Health Canada)

Senior Regulatory Affairs Specialist (IVD Exp. supporting US / Health Canada)

HaemoneticsBoston, MA, US
serp_jobs.job_card.full_time
We are constantly looking to add to our core talent.If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further Haemonetics is yo...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
Specialist, Regulatory Affairs

Specialist, Regulatory Affairs

Redefine Your Future with TransMedicsAndover, MA, US
serp_jobs.job_card.full_time
Specialist, Regulatory Affairs.Due to rapid growth, we are currently looking for a Specialist, Regulatory Affairs, based in our Andover, MA headquarters, to join us as we revolutionize this cutting...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
Senior Regulatory Affairs Director - Oncology

Senior Regulatory Affairs Director - Oncology

AstraZenecaBoston, MA, US
serp_jobs.job_card.full_time
Senior Regulatory Affairs Director.Are you a strategically focused Regulatory professional and would like to play an integral part in bringing life-changing Oncology medicines to patients? If you a...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
  • serp_jobs.job_card.promoted
  • serp_jobs.job_card.new
Senior Director Global Regulatory Affairs - Global Regulatory Lead - Neuroscience

Senior Director Global Regulatory Affairs - Global Regulatory Lead - Neuroscience

Takeda PharmaceuticalBoston, MA, US
serp_jobs.job_card.full_time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that.I provide in my application will be processed in line with.I further...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
  • serp_jobs.job_card.promoted
Senior Manager Regulatory Affairs

Senior Manager Regulatory Affairs

VirtualVocationsDorchester, Massachusetts, United States
serp_jobs.job_card.full_time
A company is looking for a Senior Manager, Regulatory Affairs US Advertising and Promotion - Immunology (Remote).Key Responsibilities Proactively monitors and communicates changes in pharmaceutic...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
  • serp_jobs.job_card.promoted
Senior Director, Regulatory Affairs CMC Policy and Advocacy

Senior Director, Regulatory Affairs CMC Policy and Advocacy

Alnylam PharmaceuticalsCambridge, MA, United States
serp_jobs.job_card.full_time
The Senior Director, Regulatory Affairs CMC Policy and Advocacy will lead the development and implementation of global regulatory advocacy strategies. This role will also oversee global regulatory C...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
  • serp_jobs.job_card.promoted
Senior Regulatory Affairs Specialist (IVD Exp. supporting US / Health Canada)

Senior Regulatory Affairs Specialist (IVD Exp. supporting US / Health Canada)

Haemonetics Software SolutionsBoston, MA, United States
serp_jobs.job_card.full_time
Haemonetics is committed to the protection of personal data in accordance with applicable laws and regulations.The editor and data controller ofwww. Haemonetics Corporation, 125 Summer Street, Bosto...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30