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Cmc Jobs in Texas (NOW HIRING)

UTMB Health

Staff Psychiatrist, CHS-CMC - CASUAL

Stafford, TX · On-site

$215K - $268K/yr

Staff Psychiatrist, CHS-CMC - CASUAL Stafford, Texas, United States Hot Physician UTMB Health Requisition # 2503005 The mission of Correctional Managed Care is to address the healthcare needs of ...

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How much do cmc jobs pay per hour?

As of Aug 23, 2026, the average hourly pay for cmc in Texas is $29.11, according to ZipRecruiter salary data. Most workers in this role earn between $17.93 and $34.04 per hour, depending on experience, location, and employer.

What is a CMC?

CMC stands for Chemistry, Manufacturing, and Controls. CMC professionals are responsible for ensuring that pharmaceutical products are developed, manufactured, and controlled in compliance with regulatory standards. Their work includes overseeing formulation development, analytical testing, process validation, and documentation required for regulatory submissions. CMC experts play a critical role in bringing safe and effective drugs to market by ensuring product quality and consistency throughout the development and manufacturing process.

What are some common challenges faced by a CMC professional when coordinating between R&D, manufacturing, and regulatory teams?

CMC professionals often encounter challenges in aligning the timelines and priorities of R&D, manufacturing, and regulatory teams. Ensuring that product development meets both regulatory requirements and manufacturing feasibility can require extensive cross-functional communication and problem-solving. Additionally, adapting to evolving regulatory guidelines and integrating feedback from multiple stakeholders demands strong project management skills. Overcoming these challenges is essential for maintaining project momentum and ensuring successful product submissions.

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

To thrive as a CMC professional, you need expertise in pharmaceutical sciences, regulatory requirements, and process development, typically supported by a degree in chemistry, pharmacy, or a related field. Familiarity with regulatory submission systems, analytical tools, and quality management software is essential. Strong project management, attention to detail, and effective communication are vital soft skills for coordinating cross-functional teams and ensuring compliance. These skills and qualities are critical to guarantee the safety, efficacy, and regulatory approval of pharmaceutical products.

What is the difference between CMC vs Regulatory Affairs Specialist?

AspectCMCRegulatory Affairs Specialist
Required CredentialsBachelor's degree in life sciences, chemistry, or pharmacy; often additional certifications in pharmaceutical sciencesBachelor's degree in life sciences, pharmacy, or related field; certifications in regulatory affairs are common
Work EnvironmentLaboratories, manufacturing sites, and R&D departments within pharmaceutical companiesRegulatory agencies, pharmaceutical companies, and consulting firms
Industry UsageFocuses on drug development, manufacturing, and quality documentationFocuses on compliance, submissions, and communication with regulatory bodies

While both CMC and Regulatory Affairs Specialists work within the pharmaceutical industry, CMC professionals primarily handle the chemistry, manufacturing, and control aspects of drug development. Regulatory Affairs Specialists focus on ensuring compliance with regulations and managing submissions to authorities. Both roles often collaborate but serve distinct functions in bringing a drug to market.

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Cmc jobs near you
Infographic showing various Cmc job openings in Texas as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 16% Part Time, and 2% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $60,545 per year, or $29.1 per hour.

Associate Director, Regulatory Affairs - CMC

Orano

Plano, TX • On-site

Full-time

Posted 26 days ago

Job description

Description
Orano Med Theranostics
Orano Med has developed new processes for producing high-purity lead-212, a rare radioactive isotope. Lead-212 is currently at the heart of promising research projects in nuclear medicine to develop new treatments against cancer. The innovative approach, known as targeted alpha therapy (TAT), recognizes and destroys cancer cells while limiting the impact on nearby healthy cells.
The Associate Director, Regulatory Affairs - CMC will be responsible for leading the global regulatory CMC strategy for product development and registration, and for the preparation of CMC dossier in the expanding field of radiopharmaceuticals in the US and in EU.
This global role will join the regulatory team and will report directly to the Head of Regulatory Affairs. The person will work cross-functionally with the CMC team and the manufacturing sites to lead the regulatory CMC strategy and the preparation of regulatory CMC documentation and submissions in adherence to relevant regulatory requirements and company standards.
Key Responsibilities:
  • Leads the development and preparation of global (US and EU) CMC-related submission documents for the pipeline of radiopharmaceutical products. This includes authoring, review and consolidation to deliver high-quality documents. Working in close collaboration with the CMC team (Manufacturing, Quality, R&D process), the regulatory CMC lead will collect technical data from relevant partners to write regulatory CMC documents and support the overall project goals.
  • Develops robust global regulatory CMC strategies for the pipeline of radiopharmaceutical products. Identifies risks and proposes risk mitigation to enable successful regulatory submissions and approvals. Aligns within Regulatory Affairs to enable one regulatory voice.
  • The regulatory submissions include but are not limited to the M3/CMC section of INDs/CTAs (IMPD-Q), DMF/ASMF, briefing documents, response to queries, Orphan Drug Applications, and annual reports.
  • Manages regulatory CMC agency interactions and meetings.
  • Meets current regulatory standards and achieves timely submissions, to enable approval on the first review cycle. Effectively interprets and applies regulatory CMC guidance. Provides recommendations and solutions to cross-functional teams and key stakeholders.
  • Works with the Regulatory Operations vendor to coordinate publishing and submission for CMC dossiers (eCTD)
  • Leads or contributes to the development of internal processes to improve the regulatory and CMC ways of working.
  • Remains current on CMC regulatory intelligence.

Requirements
All candidates must meet the following minimum requirements in order to be considered for this opportunity. Candidates who exceed minimum qualifications may be considered for a higher-level position.
Minimum Qualifications:
  • Bachelor's degree in a scientific discipline. Advanced degree (MS, PharmD or PhD) is a plus.
  • A minimum of 8 years Regulatory CMC experience and/or CMC technical writing experience in a pharmaceutical or biotechnology environment including injectables.

Required Skills and Competencies:
  • Demonstrated hands-on experience in pharmaceutical development, registration in the US and/or EU, and interaction with health authorities. Demonstrated experience in preparing regulatory submissions, including IND/CTA, NDA/MAA, DMF/ASMF, briefing documents, and response to agency questions.
  • Technical knowledge in small molecules with experience in translating to a regulatory document. Knowledge of radiopharmaceuticals and innovative platforms is a plus.
  • Knowledge of relevant global CMC regulations and guidelines (ICH, US, EU)
  • Experience within a GMP environment with a firm understanding of industry regulations and best practices
  • Ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
  • Excellent verbal and written communication skills. Able to defend the regulatory CMC position while maintaining positive professional relationships
  • Proactive, able to work independently and collaboratively in a fast-paced emerging field
  • Analytical thinker with good problem-solving skills and the capacity to adapt to a field with relatively few guidelines available.
  • Excellent planning and organization skills including the ability to support multiple projects.
  • Proficiency with Microsoft Office.
  • Travel requirements: Up to 10% travel

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