CMC Writer
Paramus, NJ · On-site
CMC Writer Job Location: Paramus, NJ Job Type: Contract * Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format. * Manage timelines and deliverables ...
Quick apply
Paramus, NJ · On-site
CMC Writer Job Location: Paramus, NJ Job Type: Contract * Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format. * Manage timelines and deliverables ...
Quick apply
Paramus, NJ · On-site
CMC Writer Job Location: Paramus, NJ Job Type: Contract * Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format. * Manage timelines and deliverables ...
Paramus, NJ · On-site
CMC Writer Job Location: Paramus, NJ Job Type: Contract * Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents ...
Quick apply
Paramus, NJ · On-site
CMC Writer Job Location: Paramus, NJ Job Type: Contract * Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents ...
Framingham, MA · On-site
CMC dossier leader * Location: Framingham, MA About the job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and ...
Framingham, MA · On-site
CMC dossier leader * Location: Framingham, MA About the job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and ...
The CMC Lead will develop, execute, and maintain the integrated CMC strategy and plan grounded in Quality by Design (QbD) principles, aligned to Stage-Gate requirements, spanning Drug Substance, Drug ...
The CMC Lead will develop, execute, and maintain the integrated CMC strategy and plan grounded in Quality by Design (QbD) principles, aligned to Stage-Gate requirements, spanning Drug Substance, Drug ...
CMC dossier leader * Location: Framingham, MA About the job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and ...
CMC dossier leader * Location: Framingham, MA About the job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and ...
Paramus, NJ · On-site
$45 - $50/hr
CMC Writer Location: Paramus, New Jersey, 07652 Job Type: Contract Duration: 6 Months Work Type: Hybrid * A Pharmaceutical CMC (Chemistry, Manufacturing, and Controls) Writer plays a crucial role in ...
Quick apply
Paramus, NJ · On-site
$45 - $50/hr
CMC Writer Location: Paramus, New Jersey, 07652 Job Type: Contract Duration: 6 Months Work Type: Hybrid * A Pharmaceutical CMC (Chemistry, Manufacturing, and Controls) Writer plays a crucial role in ...
Lawndale, CA · Hybrid
Overview The Director of CMC is responsible for day-to-day leadership and execution of Critical Innovations' Chemistry, Manufacturing, and Controls (CMC) activities, with primary oversight over ...
Quick apply
Lawndale, CA · Hybrid
Overview The Director of CMC is responsible for day-to-day leadership and execution of Critical Innovations' Chemistry, Manufacturing, and Controls (CMC) activities, with primary oversight over ...
Framingham, MA · On-site
Job Title: CMC Project Leader Location: Framingham, MA About the Job As the CMC Project Lead within our Cluster Mammalian Project team, you'll be accountable for the CMC project activities of ...
Framingham, MA · On-site
Job Title: CMC Project Leader Location: Framingham, MA About the Job As the CMC Project Lead within our Cluster Mammalian Project team, you'll be accountable for the CMC project activities of ...
Framingham, MA · On-site +1
Job Title: CMC Project Leader Location: Framingham, MA About the Job As the CMC Project Lead within our Cluster Mammalian Project team, you'll be accountable for the CMC project activities of ...
Framingham, MA · On-site +1
Job Title: CMC Project Leader Location: Framingham, MA About the Job As the CMC Project Lead within our Cluster Mammalian Project team, you'll be accountable for the CMC project activities of ...
Cambridge, MA · On-site
CMC dossier leader * Location: Framingham, MA About the job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and ...
Cambridge, MA · On-site
CMC dossier leader * Location: Framingham, MA About the job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and ...
El Segundo, CA · On-site
$200K - $230K/yr
This role will be responsible for all CMC activities across the external drug development pipeline of Varda's partners. Reporting to the VP, Pharma Program Management), this position requires ...
El Segundo, CA · On-site
$200K - $230K/yr
This role will be responsible for all CMC activities across the external drug development pipeline of Varda's partners. Reporting to the VP, Pharma Program Management), this position requires ...
Framingham, MA · On-site
CMC dossier leader * Location: Framingham, MA About the job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and ...
Framingham, MA · On-site
CMC dossier leader * Location: Framingham, MA About the job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and ...
Framingham, MA · On-site +1
Job Title: CMC Project Leader Location: Framingham, MA About the Job As the CMC Project Lead within our Cluster Mammalian Project team, you'll be accountable for the CMC project activities of ...
Framingham, MA · On-site +1
Job Title: CMC Project Leader Location: Framingham, MA About the Job As the CMC Project Lead within our Cluster Mammalian Project team, you'll be accountable for the CMC project activities of ...
$180K - $205K/yr
The Director, CMC Regulatory reports to the Senior Director, Regulatory Affairs and will provide strategic leadership and hands-on subject-matter expertise to enable end-to-end vaccine development ...
$180K - $205K/yr
The Director, CMC Regulatory reports to the Senior Director, Regulatory Affairs and will provide strategic leadership and hands-on subject-matter expertise to enable end-to-end vaccine development ...
Framingham, MA · On-site
Job Title: CMC Project Leader Location: Framingham, MA About the Job As the CMC Project Lead within our Cluster Mammalian Project team, you'll be accountable for the CMC project activities of ...
Framingham, MA · On-site
Job Title: CMC Project Leader Location: Framingham, MA About the Job As the CMC Project Lead within our Cluster Mammalian Project team, you'll be accountable for the CMC project activities of ...
$153.50K - $202.70K/yr
As a CMC Regulatory Strategist, you will have the opportunity to provide strategic and tactical leadership to Rho clients and project teams in support of our clients' interdisciplinary pharmaceutical ...
$153.50K - $202.70K/yr
As a CMC Regulatory Strategist, you will have the opportunity to provide strategic and tactical leadership to Rho clients and project teams in support of our clients' interdisciplinary pharmaceutical ...
San Francisco, CA · On-site
$176.70K - $233.30K/yr
Director, Regulatory CMC Location: San Francisco, CA (Onsite - 4 days/week) Industry: Biotechnology / Pharmaceutical Job Summary We are seeking an experienced Director, Regulatory CMC (Chemistry ...
Quick apply
San Francisco, CA · On-site
$176.70K - $233.30K/yr
Director, Regulatory CMC Location: San Francisco, CA (Onsite - 4 days/week) Industry: Biotechnology / Pharmaceutical Job Summary We are seeking an experienced Director, Regulatory CMC (Chemistry ...
El Segundo, CA · On-site
$200K - $230K/yr
This role will be responsible for all CMC activities across the external drug development pipeline of Varda's partners. Reporting to the VP, Pharma Program Management), this position requires ...
El Segundo, CA · On-site
$200K - $230K/yr
This role will be responsible for all CMC activities across the external drug development pipeline of Varda's partners. Reporting to the VP, Pharma Program Management), this position requires ...
You will translate CMC strategy into actionable, integrated plans that enable timely clinical and regulatory progress. This role is highly cross-functional and requires close collaboration with ...
You will translate CMC strategy into actionable, integrated plans that enable timely clinical and regulatory progress. This role is highly cross-functional and requires close collaboration with ...
You will translate CMC strategy into actionable, integrated plans that enable timely clinical and regulatory progress. This role is highly cross-functional and requires close collaboration with ...
You will translate CMC strategy into actionable, integrated plans that enable timely clinical and regulatory progress. This role is highly cross-functional and requires close collaboration with ...
$18.48 is the 25th percentile. Wages below this are outliers.
$13.94 - $18.77
27% of jobs
The median wage is $23.39 / hr.
$18.77 - $23.60
24% of jobs
$23.60 - $28.43
18% of jobs
$31.75 is the 75th percentile. Wages above this are outliers.
$28.43 - $33.26
9% of jobs
$33.26 - $38.09
6% of jobs
$38.09 - $42.92
9% of jobs
$42.92 - $47.75
4% of jobs
$47.75 - $52.58
2% of jobs
$52.58 - $57.41
0% of jobs
$57.41 - $62.24
1% of jobs
$62.24 - $67.07
0% of jobs
$13
$31
$67
| Aspect | CMC | Regulatory Affairs Specialist |
|---|---|---|
| Required Credentials | Bachelor's degree in life sciences, chemistry, or pharmacy; often additional certifications in pharmaceutical sciences | Bachelor's degree in life sciences, pharmacy, or related field; certifications in regulatory affairs are common |
| Work Environment | Laboratories, manufacturing sites, and R&D departments within pharmaceutical companies | Regulatory agencies, pharmaceutical companies, and consulting firms |
| Industry Usage | Focuses on drug development, manufacturing, and quality documentation | Focuses on compliance, submissions, and communication with regulatory bodies |
While both CMC and Regulatory Affairs Specialists work within the pharmaceutical industry, CMC professionals primarily handle the chemistry, manufacturing, and control aspects of drug development. Regulatory Affairs Specialists focus on ensuring compliance with regulations and managing submissions to authorities. Both roles often collaborate but serve distinct functions in bringing a drug to market.

Job Title: CMC Writer
Job Location: Paramus, NJ
Job Type: Contract
Job Description:
Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format.
Manage timelines and deliverables for CMC workstreams, ensuring alignment with project goals.
Prepare and coordinate CMC documentation for AR, DSUR, and responses to regulatory authority questions.
Ensure compliance with FDA, EMA, and ICH guidelines and internal processes.
Collaborate with cross-functional teams to gather accurate technical information.
Identify and communicate potential regulatory risks; propose mitigation strategies.
Support process improvement initiatives for CMC submission workflows.
Sourced by ZipRecruiter
Recruiting and staffing services
51 - 200 Employees
Atlanta, GA, US
2016