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Cmc Regulatory Jobs (NOW HIRING)

Retro

CMC Regulatory Lead

Redwood City, CA

$200K - $240K/yr

We're hiring an experienced CMC Regulatory Lead to own the strategy and operations for our Chemistry, Manufacturing, and Controls (CMC) regulatory work. As one of the earliest members of the ...

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 ...

Retro

CMC Regulatory Lead

Redwood City, CA · On-site

$200K - $240K/yr

We're hiring an experienced CMC Regulatory Lead to own the strategy and operations for our Chemistry, Manufacturing, and Controls (CMC) regulatory work. As one of the earliest members of the ...

Retro

CMC Regulatory Lead

Redwood City, CA

$200K - $240K/yr

We're hiring an experienced CMC Regulatory Lead to own the strategy and operations for our Chemistry, Manufacturing, and Controls (CMC) regulatory work. As one of the earliest members of the ...

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 ...

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Cmc Regulatory information

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$15

$34

$145

How much do cmc regulatory jobs pay per hour?

As of Jul 13, 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.
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Cmc Regulatory jobs near you
Infographic showing various Cmc Regulatory job openings in the United States as of July 2026, with employment types broken down into 18% Internship, 1% As Needed, 68% Full Time, 11% Part Time, and 2% Contract. Highlights an 91% Physical, 2% Hybrid, and 7% Remote job distribution, with an average salary of $71,960 per year, or $34.6 per hour.

CMC Regulatory Lead

Retro

Redwood City, CA

$200K - $240K/yr

Full-time

Medical, Dental, Vision, Retirement

Posted 21 days ago

Job description

Retro develops therapies for diseases driven by the biology of aging. We focus on cellular reprogramming and autophagy to rejuvenate cell and tissue function with the ultimate aim of adding 10 years to healthy human lifespan.
 
We're hiring an experienced CMC Regulatory Lead to own the strategy and operations for our Chemistry, Manufacturing, and Controls (CMC) regulatory work. As one of the earliest members of the Regulatory Affairs team, you will work across Retro's programs and play a leading role in building out the regulatory CMC capabilities and strategies to achieve our ambitious mission and tackle aging. You will report directly to the leader of Regulatory Affairs.
 
This position is an onsite role based in Redwood City.
 
About you:
You are a builder and doer who can set clear, global CMC regulatory strategies and roll up your sleeves to execute them at speed. You are energized by complex CMC challenges, especially in cell therapy, and you anticipate questions before they become risks. You translate technical details into clear regulatory narratives that resonate with health authorities, and you are comfortable serving as the CMC regulatory point person in high-stakes health-authority interactions.
 
You have high-collaboration and low-ego tendencies, with the ability to align cross-functional technical teams and external partners around a shared regulatory CMC plan and clear deliverables. You bring strong operational discipline, enjoy creating structure when needed, and are mission-driven with genuine motivation to advance longevity and aging biology for the benefit of humanity.
In this role, you will:
  • Be accountable for the regulatory CMC activities for Retro's programs, which include both cell therapies and small molecules.
  • Develop the regulatory CMC strategy for each program and lead the execution of global CMC regulatory plans.
  • Lead the preparation of the CMC dossier for INDs/CTAs and marketing applications, as well as the CMC documents for amendments, annual reports, and other CMC regulatory submissions.
  • Act as Retro's regulatory liaison with health authorities for CMC communications and submissions.
  • Lead health-authority meetings with FDA and other health authorities for CMC-related topics.
  • Lead the responses to health-authority queries and information requests related to CMC.
  • Identify regulatory CMC risks and develop creative and innovative mitigation strategies.
  • Partner closely with key internal functions, including Analytical Development, Process Development, Scientific Operations, and Quality.
  • Provide regulatory CMC guidance and oversight to external CDMOs and other vendors.
  • Help establish scalable regulatory CMC processes and approaches in a growing biotech organization.
You will thrive in this role if you:
  • Have a bachelor's degree in a life sciences discipline or equivalent (advanced degree preferred).
  • 7+ years of hands-on experience in regulatory CMC.
  • Demonstrated experience leading CMC regulatory strategy for cell therapies.
  • Experience working in early phase development (IND/CTA-enabling through Phase 1/2) with pragmatic, stage-appropriate CMC approaches.
  • Proven ability to lead cross-functional workstreams, manage multiple priorities, and deliver high-quality outputs under tight timelines.
  • Strong interest in longevity and aging biology, and motivation to work in a field where the playbook is still being written.
It's a bonus if you:
  • Have experience working on iPSC-derived cell therapies.
  • Have experience across multiple product modalities (e.g., cell/gene therapy, small molecules, biologics, etc.).
  • Experience in late phase development (e.g., Phase 3) and registrational/commercial settings.
  • Extensive global experience, including in non-traditional jurisdictions and emerging markets. 
$200,000 - $240,000 a year
At Retro, we don't use titles. New hires join as a "Member of X Team." Depending on experience, this role is approximate to Director level.
 
Total compensation also includes generous equity and benefits including:
- Medical, dental, and vision insurance for you and your family
- 401(k) plan with 4% matching
- Unlimited time off and 10 company holidays per year
- Paid parental leave
- Annual learning & development stipend 
- Monthly longevity stipend
- Free lunch and snacks
We take pride in cultivating an environment that fosters collaboration, open communication, and authenticity. We believe that great results are best delivered by a highly creative team working in concert. We are an equal opportunity employer; we do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We are diverse in background and singular in mission.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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