The Regional Regulatory Manager is responsible for the execution of the regulatory strategy for ... Drive the regulatory submission in your respective region. Ensure optimal planning in alignment ...
The Regional Regulatory Manager is responsible for the execution of the regulatory strategy for ... Drive the regulatory submission in your respective region. Ensure optimal planning in alignment ...
Manage regulatory submission timelines, deliverables, and tracking across cross-functional teams to ensure high-quality and on-time submissions. * Coordinate regulatory submission activities ...
Manage regulatory submission timelines, deliverables, and tracking across cross-functional teams to ensure high-quality and on-time submissions. * Coordinate regulatory submission activities ...
Regional Regulatory Manager
Billerica, MA · On-site
The Regional Regulatory Manager is responsible for the execution of the regulatory strategy for ... Drive the regulatory submission in your respective region. Ensure optimal planning in alignment ...
Regional Regulatory Manager
Billerica, MA · On-site
The Regional Regulatory Manager is responsible for the execution of the regulatory strategy for ... Drive the regulatory submission in your respective region. Ensure optimal planning in alignment ...
Manage regulatory submission timelines, deliverables, and tracking across cross-functional teams to ensure high-quality and on-time submissions. * Coordinate regulatory submission activities ...
Quick apply
Manage regulatory submission timelines, deliverables, and tracking across cross-functional teams to ensure high-quality and on-time submissions. * Coordinate regulatory submission activities ...
Manager, Regulatory CMC
Somerset, NJ · Hybrid
... global regulatory submissions, including INDs, CTAs, BLAs, MAAs, amendments, supplements, and ... Strong project management and organizational skills. * Ability to manage multiple programs and ...
Manager, Regulatory CMC
Somerset, NJ · Hybrid
... global regulatory submissions, including INDs, CTAs, BLAs, MAAs, amendments, supplements, and ... Strong project management and organizational skills. * Ability to manage multiple programs and ...
... manager, and formulation chemists to create and maintain CSFs according to current federal guidance to meet compliance requirements and is responsible for the regulatory submission process including ...
New
... manager, and formulation chemists to create and maintain CSFs according to current federal guidance to meet compliance requirements and is responsible for the regulatory submission process including ...
New
... manager, and formulation chemists to create and maintain CSFs according to current federal guidance to meet compliance requirements and is responsible for the regulatory submission process including ...
New
... manager, and formulation chemists to create and maintain CSFs according to current federal guidance to meet compliance requirements and is responsible for the regulatory submission process including ...
New
Regulatory Affairs Manager
Indianapolis, IN · On-site
$50 - $53/hr
Coordinate and compile regulatory submission dossiers to meet planned product registration timelines. * Develop and manage parts of comprehensive global regulatory submission and registration plans ...
New
Regulatory Affairs Manager
Indianapolis, IN · On-site
$50 - $53/hr
Coordinate and compile regulatory submission dossiers to meet planned product registration timelines. * Develop and manage parts of comprehensive global regulatory submission and registration plans ...
New
Manage regulatory submission timelines, deliverables, and tracking across cross-functional teams to ensure high-quality and on-time submissions. * Coordinate regulatory submission activities ...
Manage regulatory submission timelines, deliverables, and tracking across cross-functional teams to ensure high-quality and on-time submissions. * Coordinate regulatory submission activities ...
Regulatory Submissions Specialist
New Haven, CT · On-site
$76 - $99/hr
... Manager, Adobe Acrobat Plug-In software, etc) for electronic, paper or hybrid submissions ... Provide regulatory guidance on quality, preclinical and clinical documentation to ensure submission ...
Regulatory Submissions Specialist
New Haven, CT · On-site
$76 - $99/hr
... Manager, Adobe Acrobat Plug-In software, etc) for electronic, paper or hybrid submissions ... Provide regulatory guidance on quality, preclinical and clinical documentation to ensure submission ...
Regulatory Submissions Specialist
$76K - $99K/yr
... Manager, Adobe Acrobat Plug-In software, etc) for electronic, paper or hybrid submissions ... Provide regulatory guidance on quality, preclinical and clinical documentation to ensure submission ...
Regulatory Submissions Specialist
$76K - $99K/yr
... Manager, Adobe Acrobat Plug-In software, etc) for electronic, paper or hybrid submissions ... Provide regulatory guidance on quality, preclinical and clinical documentation to ensure submission ...
... Submission manager, assigned to respective franchise/activity with clear accountability for ... Create and maintain regulatory affairs documents like QCP, SWI as applicable for all aspects of ...
... Submission manager, assigned to respective franchise/activity with clear accountability for ... Create and maintain regulatory affairs documents like QCP, SWI as applicable for all aspects of ...
Regulatory Submissions Specialist
New Haven, CT · On-site
$76K - $99K/yr
... Manager, Adobe Acrobat Plug-In software, etc) for electronic, paper or hybrid submissions ... Provide regulatory guidance on quality, preclinical and clinical documentation to ensure submission ...
Regulatory Submissions Specialist
New Haven, CT · On-site
$76K - $99K/yr
... Manager, Adobe Acrobat Plug-In software, etc) for electronic, paper or hybrid submissions ... Provide regulatory guidance on quality, preclinical and clinical documentation to ensure submission ...
Site Contracts Lead (4 Month Contract)
$91K - $121K/yr
Works with Premier Regulatory Submission Managers to provide final CTA and/or budget per country/site as needed for country regulatory submissions. * Independently communicates with Premier ...
Site Contracts Lead (4 Month Contract)
$91K - $121K/yr
Works with Premier Regulatory Submission Managers to provide final CTA and/or budget per country/site as needed for country regulatory submissions. * Independently communicates with Premier ...
Partner with Regulatory Project Management and Submission Management. * May act as direct contact to a local HA (e.g. FDA or EMA). Lead the direct interactions with the respective local HA in this ...
Partner with Regulatory Project Management and Submission Management. * May act as direct contact to a local HA (e.g. FDA or EMA). Lead the direct interactions with the respective local HA in this ...
Associate Director / Director, Regulatory Affairs CMC
Bothell, WA · On-site
$177K - $238K/yr
This individual will manage key deliverables and ensure adherence to accelerated regulatory submission schedules. Reporting into the Senior Director, Regulatory Affairs CMC, the role is responsible ...
Associate Director / Director, Regulatory Affairs CMC
Bothell, WA · On-site
$177K - $238K/yr
This individual will manage key deliverables and ensure adherence to accelerated regulatory submission schedules. Reporting into the Senior Director, Regulatory Affairs CMC, the role is responsible ...
Partner with Regulatory Project Management and Submission Management. * May act as direct contact to a local HA (e.g. FDA or EMA). Lead the direct interactions with the respective local HA in this ...
Partner with Regulatory Project Management and Submission Management. * May act as direct contact to a local HA (e.g. FDA or EMA). Lead the direct interactions with the respective local HA in this ...
Regulatory Operations Jr. Project Manager
Saint Louis, MO · Remote
$42 - $49/hr
Regulatory Operations Jr. Project Manager Location: Remote (National) Schedule: Standard business ... Submission Planning & Scheduling: Partner with product teams to define submission timelines and ...
Quick apply
Regulatory Operations Jr. Project Manager
Saint Louis, MO · Remote
$42 - $49/hr
Regulatory Operations Jr. Project Manager Location: Remote (National) Schedule: Standard business ... Submission Planning & Scheduling: Partner with product teams to define submission timelines and ...
Regulatory Manager
East Hanover, NJ · On-site
Drives coordination, planning, and submission of dossiers in assigned regions worldwide. Review of ... management system. Ensures quality and compliance with global regulatory requirements (regions ...
Regulatory Manager
East Hanover, NJ · On-site
Drives coordination, planning, and submission of dossiers in assigned regions worldwide. Review of ... management system. Ensures quality and compliance with global regulatory requirements (regions ...
Be Seen First
Regulatory Program Manager
San Francisco, CA · On-site
$150K - $180K/yr
Partner with Regulatory Affairs to map submission strategy into concrete deliverables, owners, and timelines for technical documentation, testing, labeling, and design history file readiness.
Quick apply
Be Seen First
Regulatory Program Manager
San Francisco, CA · On-site
$150K - $180K/yr
Partner with Regulatory Affairs to map submission strategy into concrete deliverables, owners, and timelines for technical documentation, testing, labeling, and design history file readiness.
Regulatory Submission Manager information
See salary details
$54.5K - $66.1K
12% of jobs
$75.8K is the 25th percentile. Wages below this are outliers.
$66.1K - $77.7K
16% of jobs
$77.7K - $89.3K
11% of jobs
The median wage is $94.2K / yr.
$89.3K - $100.9K
28% of jobs
$100.9K - $112.5K
5% of jobs
$122.6K is the 75th percentile. Wages above this are outliers.
$112.5K - $124K
4% of jobs
$124K - $135.6K
4% of jobs
$135.6K - $147.2K
2% of jobs
$147.2K - $158.8K
1% of jobs
$158.8K - $170.4K
4% of jobs
$170.4K - $182K
13% of jobs
$54.5K
$110.7K
$182K
How much do regulatory submission manager jobs pay per year?
As of Sep 3, 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 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 are the key skills and qualifications needed to thrive as a regulatory submission manager?
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?
| Aspect | Regulatory Submission Manager | Regulatory Affairs Specialist |
|---|---|---|
| Credentials | Bachelor's degree in life sciences, regulatory affairs certification often preferred | Bachelor's degree in life sciences, regulatory affairs certification beneficial |
| Work Environment | Leads submission processes, collaborates with cross-functional teams | Supports regulatory strategies, maintains documentation, and ensures compliance |
| Industry Usage | Commonly employed in pharmaceutical, biotech, and medical device companies | Widely used in similar industries, often with overlapping responsibilities |
| Search & Comparison Intent | Focuses on managing submission processes and timelines | Centers 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 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:
Full-time
Medical, Retirement, PTO
Re-posted 11 days ago
Job description
Work Your Magic with us!Start your next chapter and join EMD Serono.
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
The Regional Regulatory Manager is responsible for the execution of the regulatory strategy for their assigned projects and for supporting local regulatory activities in their region / country.
- Represent and provide input for your respective region at the GRST.
- Lead or support the respective regional regulatory sub-team.
- Drive the regulatory submission in your respective region. Ensure optimal planning in alignment with cross-functional team, and execution to plan for both development submissions and maintenance submissions to ensure ongoing compliance. Partner with Regulatory Project Management and Submission Management.
- May act as direct contact to a local HA (e.g. FDA). Lead the direct interactions with the respective local HA in this case.
- Contribute to the global regulatory strategy with local / regional strategy for assigned projects.
- Matrix leadership role of respective Regional Regulatory sub team.
- Participate in cross-functional and GRA initiatives.
Required Background
- Advanced degree (e.g., PhD, PharmD, MD, or equivalent).
- At least 1 year of regulatory affairs strategy experience in drug development in the US
- Demonstrated successful interactions with FDA related to strategy and execution of development and maintenance activities.
- Demonstrated matrix leadership skill.
Location: This is an onsite role based in our Billerica, MA facility requiring and onsite presence at least 3 days per week.
Pay Range for this position: $103,900 - $155,900. The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here: https://careers.emdgroup.com/us/en/benefits
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
Employment Type: FULL_TIME