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Regulatory Submissions Manager Jobs (NOW HIRING)

ICON

Senior Regulatory Project Manager

Blue Bell, PA · On-site +1

Identifying operational risks with projects/submissions, implementing mitigation plans, and managing issues to closure Your Profile: Responsibilities * Represents the regulatory project and ...

Zimmer, Inc.

Regulatory Affairs Manager

This includes understanding the develop regulatory submissions, managing departmental projects, creating and reviewing labeling, providing guidance and consultation for domestic and international ...

Zimmer, Inc.

Regulatory Affairs Manager

This includes understanding the develop regulatory submissions, managing departmental projects, creating and reviewing labeling, providing guidance and consultation for domestic and international ...

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Regulatory Submissions Manager information

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$54.5K

$110.7K

$182K

How much do regulatory submissions manager jobs pay per year?

As of Aug 20, 2026, the average yearly pay for regulatory submissions 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 is a regulatory submissions manager?

A Regulatory Submissions Manager is responsible for overseeing the preparation, compilation, and submission of regulatory documents to health authorities to ensure compliance with applicable laws and guidelines. They work closely with cross-functional teams, including regulatory affairs, clinical, and legal departments, to manage timelines and ensure accurate and timely filings. Their role includes maintaining awareness of regulatory requirements, coordinating responses to agency inquiries, and continuously improving submission processes. Effective communication, attention to detail, and knowledge of regulatory guidelines are key skills for success in this role.

What does a regulatory submissions manager do?

As a Regulatory Submissions Manager, your daily responsibilities often include preparing and reviewing regulatory submission documents, coordinating with internal teams (such as clinical, quality, and R&D), and managing submission timelines to ensure compliance with regulatory requirements. You will also track submission progress, respond to agency queries, and maintain up-to-date records of all communications and submission activities. The role may involve managing multiple projects simultaneously and problem-solving to address any regulatory challenges that arise. Regular collaboration with cross-functional teams is key to driving submissions forward smoothly and meeting critical deadlines.

What are the key skills and qualifications needed to thrive as a regulatory submissions manager?

To thrive as a Regulatory Submissions Manager, you need a strong background in regulatory affairs, scientific or technical disciplines, and project management, typically with a relevant bachelor’s or advanced degree. Familiarity with submission management systems such as eCTD, knowledge of FDA, EMA, or other regulatory guidelines, and certifications like RAC (Regulatory Affairs Certification) are highly beneficial. Exceptional attention to detail, organization, and strong written and verbal communication skills are vital for coordinating with cross-functional teams and ensuring timely submissions. These skills are essential for managing complex submission processes, maintaining compliance, and supporting successful product approvals.

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Regulatory Submissions Manager jobs near you
Infographic showing various Regulatory Submissions Manager job openings in the United States as of August 2026, with employment types broken down into 88% Full Time, 11% Part Time, and 1% Contract. Highlights an 81% Physical, 2% Hybrid, and 17% Remote job distribution, with an average salary of $110,733 per year, or $53.2 per hour.

Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC)

Allergan

Waltham, MA • On-site

$100 - $130/hr

Other

Medical, Dental, Vision, Retirement, PTO

Posted 2 days ago

New

Job description

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience — and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver biologics products to patients, including mAb, ADC and cell & gene therapies. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research & Development (R&D) organizations. Represents CMC on teams such as product development, Global Regulatory Product Teams and Operations brand teams to negotiate, influence, and provide strategic advice.

Responsibilities
  • Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions, including new applications and amendments, renewals annual reports, supplements and variations and responds to regulatory information
  • Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions
  • Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies
  • Responds to global regulatory information requests.
  • Develops strategies for CMC agency meetings, manages preparation for agency meetings, and manages content of pre-meeting submissions.
  • Manages products and change control with an understanding of regulations and company policies and procedures. Analyzes and approves manufacturing change requests.
  • Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions
  • Stays abreast of regulatory procedures and changes in regulatory climate. Analyzes legislation, regulation and guidance, provides analysis to the organization
  • Develops, implements, and documents policies and procedures within the regulatory affairs department. Participates in initiatives internal to RA CMC.
  • Represents CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across the company.
  • This role will work a hybrid work schedule (3 days in office & 2 days remote) from the Waltham, MA & Lake County, IL headquarters.

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications
  • Required Education: Bachelor’s Degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject. Preferred Education: Relevant advanced degree preferred. Certification a plus.
  • Required Experience: 8 years pharmaceutical experience. Preferred Experience: 10 years pharmaceutical experience including 5-plus years in regulatory affairs or 5-plus years in Discovery, R&D, or Manufacturing.
  • Experience developing and implementing successful global regulatory strategies.
  • Experience working in a complex and matrix environment.
  • Strong oral and written communication skills.
  • Note: Higher education may compensate for years of experience
Additional Information
  • Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
  • This job is eligible to participate in our long‑term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employer remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

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