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Regulatory Submission Manager Jobs (NOW HIRING)

Sapta Global Inc

Regulatory Analyst

Signal Hill, CA · On-site

Regulatory Submissions Management and Operations for Janssen R&D Project Goal (Mandatory): The management and delivery of regulatory submissions to global health authorities required to support the ...

Altimmune

CMC Director, Regulatory Affairs

Morristown, NJ · On-site

$154K - $204K/yr

Manages all aspects of regulatory CMC activities, assists in the development of regulatory submission timelines, and ensures execution to meet corporate goals * Responsible for the preparation of all ...

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Regulatory Submission Manager information

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$54.5K

$110.7K

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How much do regulatory submission manager jobs pay per year?

As of Jul 26, 2026, the average yearly pay for regulatory submission manager in the United States is $110,733.00, according to ZipRecruiter salary data. Most workers in this role earn between $77,500.00 and $136,500.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Regulatory Submission Manager, and why are they important?

To thrive as a Regulatory Submission Manager, you need in-depth knowledge of regulatory requirements, submission processes, and document management, typically supported by a degree in life sciences or a related field. Familiarity with electronic submission systems like eCTD, regulatory databases, and document tracking tools is essential, and certifications such as RAC (Regulatory Affairs Certification) may be advantageous. Strong organizational skills, attention to detail, and effective communication are vital soft skills for collaborating with cross-functional teams and ensuring timely, accurate submissions. These competencies are critical for maintaining compliance, streamlining approval processes, and supporting successful product launches in regulated industries.

What are some common challenges faced by Regulatory Submission Managers during the submission process, and how can they be addressed?

Regulatory Submission Managers often encounter challenges such as tight deadlines, evolving regulatory requirements, and coordination across multiple departments. Successfully navigating these obstacles requires strong project management skills, clear communication, and proactive planning. Utilizing up-to-date submission tracking tools and fostering close collaboration with regulatory, clinical, and quality teams can help ensure that submissions are both timely and compliant with global standards.

What is the difference between Regulatory Submission Manager vs Regulatory Affairs Specialist?

AspectRegulatory Submission ManagerRegulatory Affairs Specialist
CredentialsBachelor's degree in life sciences, regulatory affairs certification often preferredBachelor's degree in life sciences, regulatory affairs certification beneficial
Work EnvironmentLeads submission processes, collaborates with cross-functional teamsSupports regulatory strategies, maintains documentation, and ensures compliance
Industry UsageCommonly employed in pharmaceutical, biotech, and medical device companiesWidely used in similar industries, often with overlapping responsibilities
Search & Comparison IntentFocuses on managing submission processes and timelinesCenters on regulatory compliance and documentation support

The Regulatory Submission Manager primarily oversees the preparation and submission of regulatory documents, ensuring timely approval. In contrast, the Regulatory Affairs Specialist supports compliance activities and maintains regulatory documentation. Both roles require similar credentials and are integral to regulatory processes in life sciences industries, but they differ in scope and responsibilities.

What does a Regulatory Submission Manager do?

A Regulatory Submission Manager oversees the preparation, coordination, and submission of documents required by regulatory agencies to approve products such as pharmaceuticals, medical devices, or biologics. They ensure that all submissions comply with relevant regulations and guidelines, manage timelines, and collaborate with cross-functional teams including regulatory affairs, clinical, and quality departments. Their role is critical in ensuring that products reach the market efficiently and meet all legal and safety requirements.
What cities are hiring for Regulatory Submission Manager jobs? Cities with the most Regulatory Submission Manager job openings:
What states have the most Regulatory Submission Manager jobs? States with the most job openings for Regulatory Submission Manager jobs include:
Regulatory Submission Manager jobs near you
Infographic showing various Regulatory Submission Manager job openings in the United States as of July 2026, with employment types broken down into 86% Full Time, 13% Part Time, and 1% Contract. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution, with an average salary of $110,733 per year, or $53.2 per hour.
Senior CMC Regulatory Submission Manager

Senior CMC Regulatory Submission Manager

Integrated Resources INC

Lexington, MA

Contractor

Posted 4 hours ago

Job description

Company Description

A Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

Position Details: 

Client Direct Client

Location Lexington, MA

Job Title Senior CMC Regulatory Submission Manager

Duration 1 Year+

Must have skill-set [Job Description] Job Summary

Under the direction of the line manager, the CMC Regulatory Submissions Manager supports the management and oversight of the CMC Regulatory Submissions for Global Portafolio of early development programs (IMPD/CTA/IND). The Regulatory Submissions Manager is also responsible for execution of the global CMC submission process (Creation, Review, Approval, Submission and Commercial Implementation of CMC Dossiers for Marketing Applications and Post- Approval) by working closely with Product Development, Regulatory, QA, GPT and MS&T crossfunctional project teams to support the execution of operational activity, monitor adherence to the process, periodically evaluate the metrics, revise the process as required, implement changes and provide appropriate training and tools. The manager will be responsible for tracking global submission activities for Biologics and Chemically Synthesized Products. In addition, the Regulatory Submissions Manager will support the global CMC Regulatory Submissions and Document Compliance department with expertise in general pharmaceutical development of global products, submission ready standards and eCTD requirements


Responsibilities: 

Knowledge of global CMC regulatory submission requirements

including submission formats (eCTD for IND, IMPD, NDA, MAAs and NEES).

Department lead on the clinical and commercial CMC submission

processes.

Tracking global submission activities. Oversees regulatory

submissions trackers

Supports the monitoring of global CMC process, evaluation of metrics periodically, monitoring the process, supports changes and provides training and tools. Maintains operational excellence of the process.

Oversees management of the content planning of regulatory

submissions within PD.

Provides guidance for submission eCTD granularity.

Maintains oversight and executes documents to submission ready

standard for CMC regulatory submissions.

Maintains global module 3 templates.

Oversees management of Quality 3D domain: Quality Folder, PD file guide, Annex 3, Submission ready standards guide.

Maintains awareness of current trends in regulatory requirements

through literature searches and networking.

Basic knowledge of US, Canadian, European regulatory requirements for APls and drug products for biologics and chemically synthesized.

Qualifications

Qualifications:


Bachelor's degree (or higher) in Chemistry, Pharmacy, Pharmaceutics, Chemical Engineering, or closely related field is desirable.


Minimum 5 years of experience in the Pharmaceutical Industry is required.


Familiarity with pharmaceutical product development, regulatory guidelines and experience in regulatory submissions (in particular CMC Module 3 information and QOS documents) throught out the development lifecycle is highly desirable.


Experience in working with the outsourcing model is preferre

Additional Information

Feel free to forward my email to your friends/colleagues who might be available

Thanks!!!

Warm Regards,

Amrit Singh

Clinical Recruiter

Integrated Resources, Inc

IT REHAB CLINICAL NURSING

Tel: (732) 429 1634  

Fax: (732) 549 5549

http://www.irionline.com

Inc. 5000 - 2007, 2008, 2009, 2010, 2011, 2012,2013 & 2014 (8th Year)

Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70








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About Integrated Resources

Sourced by ZipRecruiter

Integrated Resources Inc (IRI), based in Edison, NJ, US, is an esteemed player in the staffing solutions industry with a credible presence on their official website irionline.com. Notably, IRI provides a range of professional staffing services including contract, contract-to-hire, and direct hire solutions to a wide spectrum of industries such as healthcare, life sciences, manufacturing, financial, insurance, and others. Since its inception, IRI has been committed to delivering top-talent and optimum solutions to meet its clients' diverse needs.

Industry

Recruiting and staffing services

Company size

51 - 200 Employees

Headquarters location

Edison, NJ, US

Year founded

1996

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