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Manager Analytical Development Jobs in Raleigh, NC

Big Lots

DEVELOPMENT MANAGER

Henderson, NC · On-site

Roughly half of the role focuses on application support, troubleshooting, and root cause analysis ... and manage incoming development and support requests. Required Qualifications Education ...

Railinc

Manager, Project Development

Cary, NC · On-site

Partners with product managers, business analysts, and other stakeholders to ensure success of the product/functionality being developed. Project Communication (20%): * Report project progress to ...

10 Federal

Business Development Manager

Raleigh, NC

The Asset & Business Development Manager will play a dual role: (1) serving as the relationship ... Monitor facility performance, analyzing P&Ls, occupancy, revenue management outcomes, and NOI ...

10 Federal

Business Development Manager

Raleigh, NC

The Asset & Business Development Manager will play a dual role: (1) serving as the relationship ... Monitor facility performance, analyzing P&Ls, occupancy, revenue management outcomes, and NOI ...

Senzit

Business Development Manager

Raleigh, NC · On-site

Market Analysis: Conduct in-depth market research to identify opportunities within the heavy-duty ... Proven experience as a Business Development Manager in the heavy-duty equipment and off-road diesel ...

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Showing results 21-40

All JobsAnalytical Development JobsManager Analytical Development JobsManager Analytical Development Jobs in Raleigh, NC

Manager Analytical Development information

See Raleigh, NC salary details

$32.1K

$75.3K

$129.3K

How much do manager analytical development jobs pay per year?

As of Aug 13, 2026, the average yearly pay for manager analytical development in Raleigh, NC is $75,276.00, according to ZipRecruiter salary data. Most workers in this role earn between $56,900.00 and $88,000.00 per year, depending on experience, location, and employer.

What are the typical day-to-day responsibilities for a manager analytical development?

As a Manager Analytical Development, your typical day involves overseeing laboratory teams, managing analytical method development and validation projects, and ensuring compliance with relevant quality standards. You’ll often collaborate with R&D, quality assurance, and production departments to support product development timelines and troubleshoot analytical challenges. Additionally, you may conduct data reviews, prepare regulatory documentation, and participate in meetings to drive project progress. Your role also includes mentoring team members and optimizing lab workflows for productivity and accuracy.

What is a manager analytical development?

A Manager Analytical Development oversees the development, validation, and implementation of analytical methods to support product development and manufacturing. They ensure compliance with regulatory standards, manage a team of scientists, and collaborate with cross-functional departments to drive innovation and efficiency. Their role is critical in ensuring product quality, consistency, and regulatory approval.

What are the key skills and qualifications needed to thrive in the manager analytical development position, and why are they important?

To excel as a Manager Analytical Development, you typically need an advanced degree in chemistry, biochemistry, or a related field, along with experience in analytical method development and leadership. Familiarity with laboratory information management systems (LIMS), chromatographic software (HPLC/UPLC), and regulatory standards such as ICH and FDA guidelines is common. Outstanding project management, team leadership, and communication skills help you effectively coordinate cross-functional projects and mentor staff. These competencies enable delivery of high-quality analytical solutions, ensure regulatory compliance, and drive successful product development.

What does a Manager Analytical Development do?

A Manager of Analytical Development oversees the design, validation, and implementation of analytical methods used to test and ensure the quality of pharmaceutical or biotech products. They lead teams of scientists, coordinate method development projects, and ensure compliance with regulatory standards such as GMP and FDA guidelines. The role often requires expertise in analytical techniques, laboratory management, and relevant certifications.
What are popular job titles related to Manager Analytical Development jobs in Raleigh, NC? For Manager Analytical Development jobs in Raleigh, NC, the most frequently searched job titles are:
What job categories do people searching Manager Analytical Development jobs in Raleigh, NC look for? The top searched job categories for Manager Analytical Development jobs in Raleigh, NC are:
What cities near Raleigh, NC are hiring for Manager Analytical Development jobs? Cities near Raleigh, NC with the most Manager Analytical Development job openings:
Manager Analytical Development jobs near you
Infographic showing various Manager Analytical Development job openings in Raleigh, NC as of July 2026, with employment types broken down into 1% Internship, 85% Full Time, 11% Part Time, and 3% Contract. Highlights an 86% Physical, 4% Hybrid, and 10% Remote job distribution, with an average salary of $75,276 per year, or $36.2 per hour.

Associate Director or Director, CMC Regulatory Affairs

Atsena

Durham, NC • On-site

$180 - $260/hr

Other

Posted 27 days ago

Job description

Position Summary

The Associate Director / Director, CMC Regulatory Affairs will lead global CMC regulatory strategy and execution for the company’s gene therapy programs from early research through clinical development and commercialization. This role is responsible for developing CMC regulatory strategies across product development stages, supporting regulatory submissions, and serving as the regulatory liaison to internal CMC teams and external contract manufacturing organizations.

The individual will work cross-functionally with process development, analytical development, manufacturing, quality, and program leadership to ensure that CMC development plans meet regulatory expectations for gene therapy products. The role will also support interactions with global regulatory authorities such as the U.S. Food and Drug Administration and the European Medicines Agency.

Key Responsibilities CMC Regulatory Strategy
  • Develop and implement global CMC regulatory strategies for gene therapy programs from early development through clinical stages and commercialization.
  • Provide regulatory guidance on viral vector manufacturing, process development, analytical characterization, and product comparability.
  • Assess regulatory risks related to manufacturing changes and propose mitigation strategies.
Regulatory Submissions
  • Lead preparation and review of CMC sections of global regulatory submissions, including: INDs and IND amendments, CTAs and IMPDs, BLA/MAA submissions and supplements, annual reports and regulatory updates
  • Ensure submissions meet regulatory expectations for gene therapy products.
Health Authority Interactions
  • Prepare CMC regulatory briefing documents and support agency meetings.
  • Serve as the subject matter expert for CMC topics during interactions with agencies including the FDA and EMA.
  • Coordinate and author responses to regulatory agency questions related to CMC.
Cross-Functional Collaboration
  • Partner closely with internal teams including: Process Development, Analytical Development, Manufacturing, Quality
  • Serve as the CMC regulatory representative on cross-functional program teams.
  • Provide regulatory guidance for manufacturing changes, comparability strategies, and lifecycle management.
Regulatory Intelligence & Compliance
  • Monitor evolving regulatory guidance related to gene therapy and advanced biologics.
  • Interpret regulatory requirements and communicate implications to internal teams.
  • Support development of internal regulatory policies and processes.
Qualifications Education
  • PhD or MS in biochemistry, molecular biology, chemical engineering, pharmaceutical sciences, or related field.
Preferred Qualifications
  • Direct experience with AAV, lentiviral, or other gene therapy platforms.
  • Experience supporting late-stage development or BLA/MAA submissions.
  • Familiarity with global regulatory frameworks for advanced therapy medicinal products (ATMPs).
  • Prior experience participating in regulatory meetings.
Associate Director Experience
  • 7–10 years of experience in regulatory affairs and CMC.
  • Experience contributing to CMC sections of IND/CTA submissions.
Director Experience
  • 10–15+ years of experience in regulatory affairs with leadership responsibility for CMC regulatory strategy.
  • Demonstrated experience leading CMC regulatory submissions and health authority interactions.
Knowledge & Skills
  • Strong knowledge of global CMC regulatory requirements for biologics and gene therapies.
  • Understanding of viral vector manufacturing processes.
  • Experience with analytical characterization, comparability, and manufacturing changes.
  • Excellent regulatory writing and communication skills.
  • Ability to work effectively in a fast-paced startup environment.
Key Competencies
  • Strategic thinking and problem solving
  • Strong scientific and regulatory expertise
  • Cross-functional leadership
  • Excellent communication and collaboration skills
  • Ability to manage multiple programs and timelines
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