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Cmc Specialist Jobs (NOW HIRING)

Watton Hall

CMC Specialist

CMC Specialist The CMC Specialist in Regulatory Affairs is responsible for overseeing the Chemistry, Manufacturing, and Controls (CMC) aspects of regulatory submissions for pharmaceutical products.

CSL

GRA CMC Specialist

King Of Prussia, PA · On-site

Ensuring operational alignment of Global Regulatory Affairs CMC activities and processes with R&D Global Regulatory Affairs and within Global Operations business needs. This role promotes strong ...

CSL

GRA CMC Specialist

King Of Prussia, PA · On-site

Ensuring operational alignment of Global Regulatory Affairs CMC activities and processes with R&D Global Regulatory Affairs and within Global Operations business needs. This role promotes strong ...

CSL Plasma Inc.

GRA CMC Specialist

Waltham, MA · On-site

$200 - $250/hr

Develop global regulatory CMC strategies for enterprise-wide CAPEX and compliance projects through collaboration with functional leaders in Global Regulatory Affairs CMC, Global Regulatory Affairs ...

CSL

GRA CMC Specialist

King Of Prussia, PA · On-site

Ensuring operational alignment of Global Regulatory Affairs CMC activities and processes with R&D Global Regulatory Affairs and within Global Operations business needs. This role promotes strong ...

CSL Plasma Inc.

$200 - $250/hr

Develop global regulatory CMC strategies for enterprise-wide CAPEX and compliance projects through collaboration with functional leaders in Global Regulatory Affairs CMC, Global Regulatory Affairs ...

CMC Hotels

$80 - $100/hr

CMC Hotels Position Type: Full-Time | Exempt We are seeking an energetic, strategic, and people-focused HR Recruiting & Talent Development Specialist to join our Human Resources team. This position ...

CMC Rescue Inc

Product Specialist

Goleta, CA · On-site

$60K - $80K/yr

The Product Specialist works closely with many different groups internal and external to CMC to ensure product viability. RESPONSIBILITIES: * Conducts product market and sales analysis to understand ...

CMC Rescue, Inc.

Product Specialist

Goleta, CA · On-site

$60 - $80/hr

The Product Specialist works closely with many different groups internal and external to CMC to ensure product viability. RESPONSIBILITIES * Conducts product market and sales analysis to understand ...

ImmunEdge, Inc

Head of CMC

Redwood City, CA · On-site

$277K - $416K/yr

There is no large internal CMC or manufacturing organization: you will execute through CDMOs, contract laboratories, and specialist consultants, while remaining personally engaged in the technical ...

ImmunEdge, Inc

Head of CMC

Redwood City, CA · On-site

$250/hr

There is no large internal CMC or manufacturing organization: you will execute through CDMOs, contract laboratories, and specialist consultants, while remaining personally engaged in the technical ...

Immunedge Inc

Head of CMC

Redwood City, CA · On-site

$277K - $416K/yr

There is no large internal CMC or manufacturing organization: you will execute through CDMOs, contract laboratories, and specialist consultants, while remaining personally engaged in the technical ...

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Cmc Specialist information

Is Cmc Specialist a good job?

A CMC (Chemistry, Manufacturing, and Controls) Specialist is responsible for ensuring regulatory compliance and quality in pharmaceutical development and manufacturing. The role typically requires strong scientific knowledge, attention to detail, and familiarity with regulatory guidelines, making it a valuable position in the biotech and pharmaceutical industries. Job satisfaction depends on individual interests in science, compliance, and project management, as well as career growth opportunities in the sector.

What states have the most Cmc Specialist jobs?

States with the most job openings for Cmc Specialist jobs include:

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Infographic showing various Cmc Specialist job openings in the United States as of September 2026, with employment types broken down into 80% Full Time, 3% Part Time, and 17% Contract. Highlights an 100% In-person job distribution.

CMC Specialist

Remote

Watton Hall
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Re-posted 18 days ago

Job description

CMC Specialist

The CMC Specialist in Regulatory Affairs is responsible for overseeing the Chemistry, Manufacturing, and Controls (CMC) aspects of regulatory submissions for pharmaceutical products. This role involves collaborating with cross-functional teams to ensure compliance with global regulatory requirements throughout the product lifecycle, from development through post-approval.

Main Responsibilities

  • Develop and compile high-quality CMC documentation required for regulatory submissions, including INDs, BLAs, NDAs, and variations
  • Ensure that all documents meet the necessary regulatory standards and guidelines.
  • Prepare necessary documentation for submission to regulatory authorities regarding these changes.
  • Work closely with Research & Development (R&D), Quality Assurance (QA), Manufacturing, and other departments to gather technical data and ensure alignment on regulatory strategies.
  • Serve as a point of contact for interactions with regulatory agencies. Prepare responses to agency inquiries and facilitate meetings as needed.
  • Provide training to junior staff members on CMC-related regulatory requirements and best practices.

Profile

  • Minimum of 3 years of experience in Regulatory Affairs focusing on CMC within the pharmaceutical or biopharmaceutical industry.
  • Bachelors degree in chemistry, biology, biochemistry.
  • Strong understanding of ICH guidelines, FDA regulations, EMA guidelines, and other relevant international regulations

Benefits

  • Remote working opportunity
  • Competitive salary, bonus and other benefits
  • Opportunity for professional development and growth
  • Excellent company culture

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