ZipRecruiter

Log In

1

Cmc Regulatory Jobs (NOW HIRING)

Rho Inc

CMC Regulatory Strategist

$153K - $202K/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 ...

Dyne Therapeutics

Director, Regulatory CMC

Waltham, MA · On-site

$161K - $213K/yr

The Director, Regulatory Affairs - Chemistry, Manufacturing, and Controls (CMC) is responsible for defining and executing global CMC regulatory strategies for Dyne programs across all stages of ...

Dyne Therapeutics

Director, Regulatory CMC

Waltham, MA

$161K - $213K/yr

The Director, Regulatory Affairs - Chemistry, Manufacturing, and Controls (CMC) is responsible for defining and executing global CMC regulatory strategies for Dyne programs across all stages of ...

Revolution Medicines

Director, Global CMC Regulatory

$153K - $202K/yr

The Director, Global CMC Regulatory is a strategic leadership role responsible for developing, driving, and executing global commercial CMC regulatory strategies to secure and maintain marketing ...

Meet Life Sciences

Director Regulatory Affairs CMC

Hayward, CA · Hybrid

$172K - $227K/yr

Director, Regulatory CMC (Hybrid - San Francisco Bay Area) We are partnering with a well-funded, clinical-stage biotechnology company with a diversified pipeline spanning both biologics and small ...

Meet Life Sciences

Director Regulatory Affairs CMC

Alameda, CA · Hybrid

$174K - $229K/yr

Director, Regulatory CMC (Hybrid - San Francisco Bay Area) We are partnering with a well-funded, clinical-stage biotechnology company with a diversified pipeline spanning both biologics and small ...

next page

Showing results 1-20

All JobsCmc Regulatory Jobs

Cmc Regulatory information

See salary details

$15

$34

$145

How much do cmc regulatory jobs pay per hour?

As of Jun 15, 2026, the average hourly pay for cmc regulatory in the United States is $34.60, according to ZipRecruiter salary data. Most workers in this role earn between $22.36 and $26.20 per hour, depending on experience, location, and employer.

What is the difference between Cmc Regulatory vs Cmc Regulatory?

AspectCmc Regulatory

Since the comparison is with itself, the focus is on clarifying roles within Cmc Regulatory. Typically, Cmc Regulatory professionals handle drug registration, compliance, and documentation related to Chemistry, Manufacturing, and Controls (CMC). They work in pharmaceutical or biotech industries, ensuring products meet regulatory standards. Their responsibilities include preparing submission dossiers, liaising with regulatory agencies, and maintaining compliance throughout product lifecycle. The role requires knowledge of regulatory guidelines, scientific understanding of drug development, and relevant certifications.

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

To thrive as a CMC Regulatory professional, you need a deep understanding of chemistry, manufacturing, and controls (CMC) principles, regulatory guidelines, and scientific documentation, often supported by a degree in life sciences or pharmacy. Familiarity with regulatory submission tools (such as eCTD), knowledge of ICH guidelines, and experience with global regulatory systems are typically required. Strong project management, communication, and analytical thinking skills help professionals excel in cross-functional teams and manage complex regulatory requirements. These competencies ensure accurate submissions, regulatory compliance, and successful product approvals within the pharmaceutical industry.

What are some common challenges faced by CMC Regulatory professionals when coordinating between cross-functional teams?

CMC Regulatory professionals often work closely with teams such as manufacturing, quality assurance, analytical development, and R&D. One common challenge is ensuring that all technical documents and data align with ever-evolving regulatory requirements across different regions. Coordinating timely updates and clarifications between departments can be complex, especially when timelines are tight or project scopes change. Effective communication and proactive project management are essential for navigating these challenges and maintaining compliance throughout the product lifecycle.

What are CMC Regulatory professionals?

CMC Regulatory professionals are experts who manage the Chemistry, Manufacturing, and Controls (CMC) aspects of pharmaceutical and biotechnology product development. They ensure that the information provided to regulatory authorities about the manufacturing process, quality control, and product specifications meets all necessary guidelines and standards. Their work is essential for obtaining and maintaining approval for drugs and biologics, as they prepare and review documentation for regulatory submissions such as INDs, NDAs, and MAAs. CMC Regulatory professionals collaborate closely with manufacturing, quality assurance, and research teams to ensure product consistency, safety, and compliance throughout the product lifecycle.
More about Cmc Regulatory jobs
What cities are hiring for Cmc Regulatory jobs? Cities with the most Cmc Regulatory job openings:
What are the most commonly searched types of Cmc Regulatory jobs? The most popular types of Cmc Regulatory jobs are:
What states have the most Cmc Regulatory jobs? States with the most job openings for Cmc Regulatory jobs include:
What job categories do people searching Cmc Regulatory jobs look for? The top searched job categories for Cmc Regulatory jobs are:
Cmc Regulatory jobs near you
Infographic showing various Cmc Regulatory job openings in the United States as of June 2026, with employment types broken down into 8% As Needed, 5% Full Time, 69% Part Time, 2% Temporary, and 16% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $71,960 per year, or $34.6 per hour.

Director, CMC Regulatory

Albert B Sabin Vaccine Institute, Inc.

Remote

$180K - $205K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 6 days ago

Job description

Job Type
Full-time
Description
Reports to: Senior Director, Regulatory Affairs
Location: Remote Work, US Only
Why Sabin:
Our mission is to make vaccines more accessible, enable innovation and expand immunization across the globe. We seek a future free from vaccine-preventable diseases. We are an innovative, collaborative, and engaged team that values accountability, teamwork, partnership and driving impact. We are vaccine champions improving lives through immunization. Sabin staff, management, and the Board of Trustees are committed to ensuring that fairness, integrity, and opportunity remain at the core of how we operate.
Position Summary:
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 from early clinical through licensure and lifecycle management with primary accountability for U.S. regulatory CMC strategy and execution. This role leads the planning, development, and delivery of high-quality CMC content and documentation, partnering closely with CMC, Quality Assurance, manufacturing/CMOs, and other cross-functional stakeholders to ensure CMC requirements are anticipated, decisions are well-framed, and filings are submission-ready. The Director is the CMC regulatory SME with demonstrated experience authoring and critically reviewing CMC sections of U.S. FDA submissions and lifecycle updates, ensuring CMC documentation consistently meets applicable regulatory expectations and supports timely development, licensure, and post-approval change management.
In addition to U.S. leadership, the Director drives CMC regulatory support for global development and access, coordinating international regulatory strategies and deliverables for European, African, and other applicable regulators. The role collaborates with internal teams and external partners to plan, prepare, author, review, track, and archive submissions and responses for international authorities; supports engagement and negotiation with regulators to resolve key CMC issues and expedite clinical trial and marketing applications; and maintains a strong global regulatory intelligence posture by monitoring evolving international requirements and relevant guideline trends (including ICH alignment). This includes practical experience with U.S. and international applications ensuring CMC documentation, comparability rationale, and control strategies are globally coherent while remaining fit-for-purpose for regional submissions and registration needs.
Key Responsibilities:
  • Work cross-functionally with CMC, Quality Assurance, and Regulatory to develop CMC regulatory strategies for the U.S. and international markets.
  • Collaborate with CMC, QA, and Regulatory to plan, prepare, author, and review CMC-related submissions to INDs, DMFs, EUAs, BLAs, and other applications as needed.
  • Identify the required documentation and address content, quality and/or timeline issues for U.S. and international submissions; coordinate timely delivery of approved technical source documents, in accordance with project timelines.
  • Provide regulatory review and impact/implementation assessments of proposed Change Control records and manage the associated regulatory notifications.
  • Lead regulatory risk assessments and develop mitigation strategies for CMC activities with potential regulatory or financial impact.
  • Proactively identify potential risks related to CMC regulatory strategy, through internal and external communications.
  • Coordinate responses to CMC information requests from U.S. FDA and/or other regulatory agencies.
  • Ensure appropriate document controls and archiving procedures, in accordance with regulatory standards and SOPs.
  • Oversee CMC regulatory activities to ensure compliance with U.S., international, and regional regulations and applicable guidelines.
  • Monitor and interpret global regulatory requirements and trends and communicate potential impact to key stakeholders.
  • Contribute to regulatory intelligence activities, including monitoring new guidelines and providing interpretive guidance to internal teams.
  • Support due diligence and regulatory assessments for potential partnerships, acquisitions, or in-licensing opportunities.

Requirements
  • Minimum bachelor's degree in biochemistry, chemistry, biology, chemical engineering, or related pharmaceutical science required, advanced degree highly desired
  • 12+ years of experience in Regulatory Affairs or related role, preferably in biologics development.
  • Proven track record in leading Regulatory CMC activities for regulatory filings in both pre- and post-approval settings.
  • Experience in regulatory oversight of validation lifecycle activities, including process performance qualification (PPQ), continued process verification (CPV), and inclusion of validation data and information in marketing applications.
  • Thorough knowledge of biologics development, cGMPs, regulatory submissions, FDA regulations, ICH guidance, and industry standards.
  • Experience preparing regulatory submissions and briefing packages for regulatory meetings.
  • Experience with Emergency Use Authorizations (EUAs) and/or BLAs is a plus.
  • Excellent interpersonal, active listening, and influencing skills.
  • Enthusiasm for problem solving, discovery, and knowledge enrichment.
  • Ability to manage complex tasks, prioritize competing objectives, and work well under pressure, maintaining clear purpose and attention to detail.
  • Team player with time-proven interpersonal skills, consistently showing respect and appreciation of co-workers and colleagues.
  • Proficient in Microsoft Office applications (Excel, Outlook, PowerPoint, Word), and Adobe Acrobat.

Other:
  • Subject to a criminal background investigation
  • Request for three professional references
  • Verification of education/degrees

Sabin's philosophy is to ensure fair, unbiased, equitable, competitive compensation and benefits. Using benchmarking and salary survey data, the annual salary for this position ranges from $180,000 - $205,000. The exact compensation may vary based on skills, experience, training, and certifications/degree. As a grant-funded organization, Sabin actively seeks funding for existing and new programs.
Sabin provides a comprehensive benefits package for eligible, featuring medical, dental, and vision coverage as well as flexible spending accounts. Eligible employees enjoy flexible vacation leave, sick leave, and both short-term and long-term disability options. The organization observes 10 federal holidays plus an end of the year winter break. Additionally, Sabin offers an employer matching 401(k) plan.
Sabin is an Equal Opportunity Employer. All applicants will be considered for employment without attention to their race, color, religion, national origin, ancestry, age, disability or genetic information, sex (including gender identity, pregnancy or sexual orientation), marital status, veteran status, or any other characteristic protected by applicable federal, state or local laws.
Salary Description
$180,000 - $205,000

Apply