... CDMO support for customer-led submissions (FDA and global). The Regulatory Affairs Manager will ... Serve as primary RA contact on project teams to support product development. * Format, publish, and ...
... CDMO support for customer-led submissions (FDA and global). The Regulatory Affairs Manager will ... Serve as primary RA contact on project teams to support product development. * Format, publish, and ...
Regulatory Affairs Manager
Columbia, SC · On-site +1
$96K - $125K/yr
... CDMO support for customer-led submissions (FDA and global). The Regulatory Affairs Manager will ... Serve as primary RA contact on project teams to support product development. * Format, publish, and ...
Regulatory Affairs Manager
Columbia, SC · On-site +1
$96K - $125K/yr
... CDMO support for customer-led submissions (FDA and global). The Regulatory Affairs Manager will ... Serve as primary RA contact on project teams to support product development. * Format, publish, and ...
... assignment of projects, and management of laboratory resources to meet analytical project ... CDMO or contract lab experience preferred * Knowledge in polymer E&L in drug finished dosage ...
... assignment of projects, and management of laboratory resources to meet analytical project ... CDMO or contract lab experience preferred * Knowledge in polymer E&L in drug finished dosage ...
Director Analytical Services
Columbia, SC · On-site
$133K - $173K/yr
... assignment of projects, and management of laboratory resources to meet analytical project ... CDMO or contract lab experience preferred * Knowledge in polymer E&L in drug finished dosage ...
Director Analytical Services
Columbia, SC · On-site
$133K - $173K/yr
... assignment of projects, and management of laboratory resources to meet analytical project ... CDMO or contract lab experience preferred * Knowledge in polymer E&L in drug finished dosage ...
Project Manager Cdmo information
See Columbia, SC salary details
$41.2K - $50.4K
4% of jobs
$50.4K - $59.7K
6% of jobs
$59.7K - $68.9K
13% of jobs
$69.7K is the 25th percentile. Wages below this are outliers.
$68.9K - $78.2K
16% of jobs
The median wage is $84.5K / yr.
$78.2K - $87.4K
15% of jobs
$87.4K - $96.7K
14% of jobs
$101.5K is the 75th percentile. Wages above this are outliers.
$96.7K - $105.9K
12% of jobs
$105.9K - $115.2K
9% of jobs
$115.2K - $124.4K
5% of jobs
$124.4K - $133.7K
3% of jobs
$133.7K - $142.9K
2% of jobs
$41.2K
$89.3K
$142.9K
How much do project manager cdmo jobs pay per year?
As of Aug 21, 2026, the average yearly pay for project manager cdmo in Columbia, SC is $89,331.00, according to ZipRecruiter salary data. Most workers in this role earn between $69,400.00 and $104,500.00 per year, depending on experience, location, and employer.
What is a project manager CDMO?
A Project Manager CDMO (Contract Development and Manufacturing Organization) is responsible for overseeing pharmaceutical or biotech projects outsourced to CDMOs. They coordinate between clients and internal teams to ensure timely delivery, quality, and compliance with regulatory standards. Their role includes managing project timelines, budgets, and resources, as well as communicating progress and addressing issues that may arise during drug development and manufacturing processes.
How does a project manager at a CDMO typically coordinate between clients and internal teams throughout a project lifecycle?
A Project Manager at a Contract Development and Manufacturing Organization (CDMO) acts as the central point of contact for clients and internal teams, ensuring clear communication and alignment of project goals. They regularly facilitate meetings, track project milestones, and proactively address potential issues or changes in scope. This involves close collaboration with departments such as R&D, manufacturing, quality assurance, and regulatory affairs to meet client expectations and project timelines. Effective project managers also document progress and maintain transparent reporting to both clients and internal stakeholders.
What are the key skills and qualifications needed to thrive as a project manager in a CDMO, and why are they important?
To excel as a Project Manager in a CDMO, you need a strong background in project management, life sciences, and regulatory compliance, often supported by a relevant degree and PMP certification. Familiarity with project management software (like MS Project or Smartsheet), quality management systems, and industry-specific regulations such as GMP are typically required. Outstanding organizational, communication, and stakeholder management skills help you effectively coordinate cross-functional teams and client expectations. These competencies are vital for delivering complex projects on time and within budget while maintaining regulatory standards and client satisfaction.
What are popular job titles related to Project Manager Cdmo jobs in Columbia, SC?
For Project Manager Cdmo jobs in Columbia, SC, the most frequently searched job titles are:
What job categories do people searching Project Manager Cdmo jobs in Columbia, SC look for?
The top searched job categories for Project Manager Cdmo jobs in Columbia, SC are:
- Client Project Manager
- Telecom Project Manager
- Part Time Project Management
- Documentation Project Manager
- It Associate Project Manager
- Senior International Project Manager
- Assistant Project Management
- Aviation Project Manager
- Senior International Development Project Management
- Remote Translation Project Manager
What cities near Columbia, SC are hiring for Project Manager Cdmo jobs?
Cities near Columbia, SC with the most Project Manager Cdmo job openings:
Job description
The Regulatory Affairs Manager is responsible for supporting development and execution of regulatory strategies for ANDA submissions as well as CDMO support for customer-led submissions (FDA and global). The Regulatory Affairs Manager will ensure compliance with regulatory requirements and manage lifecycle activities in alignment with the Director of Regulatory Affairs.
Responsibilities:
- Provide critical support in writing and editing technical documents to support submissions for internal ANDA projects as well as customer-led global submissions.
- Serve as primary RA contact on project teams to support product development.
- Format, publish, and submit documentation to the FDA for initial and lifecycle submissions.
- Respond to FDA queries and deficiencies.
- Provide guidance to RA Associates and aid in development of team.
- Develop and implement regulatory strategies for product development, registration, and maintenance across assigned markets.
- Monitor and interpret new and evolving regulations and assess impact on company products.
- Draft, review, and finalize product labeling for ANDA submissions, including structured product labeling.
- Oversee adverse event reporting process and ensure compliance with reporting requirements.
- Support due diligence activities, licensing, and partnerships.
- Bachelor of Science in Biology, Chemistry, Engineering, Pharmaceutical Sciences, or related field
- 5+ years regulatory affairs experience; FDA submission experience required, experience with device and/or drug/device combination products preferred
- Highly detail-oriented and possess considerable problem-solving and organization skills
- Ability to work on complex projects and take initiative with general direction and minimal guidance
- Ability to be flexible with a change in priorities
- Excellent written, verbal, and listening skills, must work well with others
- Experience using an electronic document control system
- Experience with eCTD publishing software preferred
- Proficient with Microsoft Word, Excel, PowerPoint, and Adobe Acrobat
About Ritedose
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
501 - 1,000 Employees
Headquarters location
Columbia, SC, US
Year founded
1995