The Senior Manager, Regulatory Affairs Global CMC will manage registration and CMC regulatory ... Support Global CMC regulatory strategy for commercial and late/early-stage development programs.
The Senior Manager, Regulatory Affairs Global CMC will manage registration and CMC regulatory ... Support Global CMC regulatory strategy for commercial and late/early-stage development programs.
Director, Regulatory CMC - Cell Therapy
Bethesda, MD · On-site
$160K - $211K/yr
Manage and actively support growth and development of direct reports * Actively participates in ... Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs ...
Director, Regulatory CMC - Cell Therapy
Bethesda, MD · On-site
$160K - $211K/yr
Manage and actively support growth and development of direct reports * Actively participates in ... Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs ...
Director, Regulatory CMC - Cell Therapy
Bethesda, MD · On-site
$160K - $211K/yr
We offer a wide variety of competitive benefits, services and programs that provide our employees ... cycle management projects of varying priorities and complexities. Represent GRS-CMC on cross ...
Director, Regulatory CMC - Cell Therapy
Bethesda, MD · On-site
$160K - $211K/yr
We offer a wide variety of competitive benefits, services and programs that provide our employees ... cycle management projects of varying priorities and complexities. Represent GRS-CMC on cross ...
Regulatory CMC Director (Cell & Gene Therapy)
Gaithersburg, MD · On-site
$162K - $213K/yr
This role positions you at the center of breakthrough programs, where your regulatory leadership ... Lifecycle Management: Manage and maintain regulatory dossiers throughout the product lifecycle ...
Regulatory CMC Director (Cell & Gene Therapy)
Gaithersburg, MD · On-site
$162K - $213K/yr
This role positions you at the center of breakthrough programs, where your regulatory leadership ... Lifecycle Management: Manage and maintain regulatory dossiers throughout the product lifecycle ...
Regulatory CMC Director (Cell & Gene Therapy)
Gaithersburg, MD · On-site
$162K - $213K/yr
This role positions you at the center of breakthrough programs, where your regulatory leadership ... Lifecycle Management: Manage and maintain regulatory dossiers throughout the product lifecycle ...
Regulatory CMC Director (Cell & Gene Therapy)
Gaithersburg, MD · On-site
$162K - $213K/yr
This role positions you at the center of breakthrough programs, where your regulatory leadership ... Lifecycle Management: Manage and maintain regulatory dossiers throughout the product lifecycle ...
Regulatory CMC Director (Cell & Gene Therapy)
Gaithersburg, MD · Hybrid
$186K - $279K/yr
This role positions you at the center of breakthrough programs, where your regulatory leadership ... Lifecycle Management: Manage and maintain regulatory dossiers throughout the product lifecycle ...
Regulatory CMC Director (Cell & Gene Therapy)
Gaithersburg, MD · Hybrid
$186K - $279K/yr
This role positions you at the center of breakthrough programs, where your regulatory leadership ... Lifecycle Management: Manage and maintain regulatory dossiers throughout the product lifecycle ...
Regulatory CMC Director (Cell & Gene Therapy)
Gaithersburg, MD · Hybrid
$162K - $213K/yr
This role positions you at the center of breakthrough programs, where your regulatory leadership ... Lifecycle Management: Manage and maintain regulatory dossiers throughout the product lifecycle ...
Regulatory CMC Director (Cell & Gene Therapy)
Gaithersburg, MD · Hybrid
$162K - $213K/yr
This role positions you at the center of breakthrough programs, where your regulatory leadership ... Lifecycle Management: Manage and maintain regulatory dossiers throughout the product lifecycle ...
Customer Care Representative I
Fort Washington, MD · On-site
$37K - $50K/yr
Conduct outbound calls and manage inbound calls according to daily dialing goals set by leadership ... Qualify program applicants, complete questionnaires and mail program applications as needed by ...
Customer Care Representative I
Fort Washington, MD · On-site
$37K - $50K/yr
Conduct outbound calls and manage inbound calls according to daily dialing goals set by leadership ... Qualify program applicants, complete questionnaires and mail program applications as needed by ...
Customer Care Representative I
Fort Washington, MD · On-site
$37K - $50K/yr
Conduct outbound calls and manage inbound calls according to daily dialing goals set by leadership ... Qualify program applicants, complete questionnaires and mail program applications as needed by ...
Customer Care Representative I
Fort Washington, MD · On-site
$37K - $50K/yr
Conduct outbound calls and manage inbound calls according to daily dialing goals set by leadership ... Qualify program applicants, complete questionnaires and mail program applications as needed by ...
Keywords Project manager, program manager, program management, pmp, project management professional, cmc, mst, msat, ms&t, manufacturing, pharmaceuticals, biotechnology, vaccine development, vaccine ...
Keywords Project manager, program manager, program management, pmp, project management professional, cmc, mst, msat, ms&t, manufacturing, pharmaceuticals, biotechnology, vaccine development, vaccine ...
Partner with functional leaders across research, clinical, regulatory, CMC, finance, new product planning, and business development to ensure alignment on program objectives and execution priorities.
Partner with functional leaders across research, clinical, regulatory, CMC, finance, new product planning, and business development to ensure alignment on program objectives and execution priorities.
Partner with functional leaders across research, clinical, regulatory, CMC, finance, new product planning, and business development to ensure alignment on program objectives and execution priorities.
Partner with functional leaders across research, clinical, regulatory, CMC, finance, new product planning, and business development to ensure alignment on program objectives and execution priorities.
Scientific Program Manager (Regulatory Affairs) (51824)
Bethesda, MD · On-site
$110K - $125K/yr
... CMC) documents, and nonclinical study report summaries. * Responsible for the management and ... program. * Ability to communicate both orally and in writing sufficient to prepare and present ...
Scientific Program Manager (Regulatory Affairs) (51824)
Bethesda, MD · On-site
$110K - $125K/yr
... CMC) documents, and nonclinical study report summaries. * Responsible for the management and ... program. * Ability to communicate both orally and in writing sufficient to prepare and present ...
... CMC) documents, and nonclinical study report summaries. * Responsible for the management and ... program. * Ability to communicate both orally and in writing sufficient to prepare and present ...
... CMC) documents, and nonclinical study report summaries. * Responsible for the management and ... program. * Ability to communicate both orally and in writing sufficient to prepare and present ...
... CMC) documents, and nonclinical study report summaries. * Responsible for the management and ... program. * Ability to communicate both orally and in writing sufficient to prepare and present ...
... CMC) documents, and nonclinical study report summaries. * Responsible for the management and ... program. * Ability to communicate both orally and in writing sufficient to prepare and present ...
Senior Project Manager with deep SAFe Release Train Engineer (RTE) expertise with COTS - Only W2
Gaithersburg, MD · On-site
The ideal candidate brings extensive IT delivery leadership in life sciences (specifically CMC or ... Manage program budgets, forecasts, vendor spend, capacity planning, and business case/benefits ...
Quick apply
Senior Project Manager with deep SAFe Release Train Engineer (RTE) expertise with COTS - Only W2
Gaithersburg, MD · On-site
The ideal candidate brings extensive IT delivery leadership in life sciences (specifically CMC or ... Manage program budgets, forecasts, vendor spend, capacity planning, and business case/benefits ...
... program plans, and ensuring consistent delivery against technical, timeline, and stakeholder ... Director, CMC Technical * Director, Sustainable Manufacturing * Monitoring and Evaluation Manage ...
... program plans, and ensuring consistent delivery against technical, timeline, and stakeholder ... Director, CMC Technical * Director, Sustainable Manufacturing * Monitoring and Evaluation Manage ...
Clinical Project Manager
Baltimore, MD · On-site
$80K - $135K/yr
Clinical Project Manager Salary Range: $80K-$135K Location: Baltimore, MD Unfortunately, we cannot ... 100+ CMC programs , and 1,397 clinical trials across all phases. Our teams are involved in ...
Clinical Project Manager
Baltimore, MD · On-site
$80K - $135K/yr
Clinical Project Manager Salary Range: $80K-$135K Location: Baltimore, MD Unfortunately, we cannot ... 100+ CMC programs , and 1,397 clinical trials across all phases. Our teams are involved in ...
Clinical Project Manager
Baltimore, MD · On-site
$80K - $135K/yr
... 100+ CMC programs, and 1,397 clinical trials across all phases. Our teams are involved in ... The Clinical Project Manager (CPM) is the single, accountable leader for early-phase (FIH, SAD/MAD ...
Quick apply
Clinical Project Manager
Baltimore, MD · On-site
$80K - $135K/yr
... 100+ CMC programs, and 1,397 clinical trials across all phases. Our teams are involved in ... The Clinical Project Manager (CPM) is the single, accountable leader for early-phase (FIH, SAD/MAD ...
Clinical Project Manager
Baltimore, MD · On-site
$80K - $135K/yr
Clinical Project Manager Salary Range: $80K-$135K Location: Baltimore, MD Unfortunately, we cannot ... 100+ CMC programs, and 1,397 clinical trials across all phases. Our teams are involved in ...
Clinical Project Manager
Baltimore, MD · On-site
$80K - $135K/yr
Clinical Project Manager Salary Range: $80K-$135K Location: Baltimore, MD Unfortunately, we cannot ... 100+ CMC programs, and 1,397 clinical trials across all phases. Our teams are involved in ...
Cmc Program Manager information
What is a CMC Program Manager?
CMC Program Managers are professionals responsible for overseeing the Chemistry, Manufacturing, and Controls (CMC) aspects of pharmaceutical or biotechnology product development. They coordinate cross-functional teams to ensure that drug development activities related to product formulation, manufacturing, quality, and regulatory submissions are completed on time and within budget. Their role is crucial in advancing products through clinical development to commercialization while ensuring compliance with global regulatory requirements.
What are the key skills and qualifications needed to thrive as a CMC Program Manager?
To thrive as a CMC Program Manager, you need expertise in chemistry, manufacturing, and controls (CMC), project management experience, and an advanced degree in life sciences or a related field. Familiarity with regulatory submission systems, quality management tools, and certifications such as PMP or Six Sigma are highly valued. Strong leadership, cross-functional communication, and problem-solving skills help manage diverse teams and complex projects effectively. These skills ensure the successful development, regulatory compliance, and timely delivery of pharmaceutical products.
What are some typical challenges a CMC Program Manager faces when coordinating cross-functional teams?
A CMC Program Manager often encounters challenges in aligning the goals and timelines of diverse teams such as process development, analytical, regulatory, and manufacturing. Communication gaps and shifting priorities can complicate project execution, especially when managing external partners or contract manufacturing organizations. Proactive stakeholder engagement and clear documentation are essential to ensure that everyone remains on track and regulatory requirements are met. Successfully navigating these complexities is key to advancing products efficiently through the development pipeline.
What is the difference between Cmc Program Manager vs Cmc Project Manager?
| Aspect | Cmc Program Manager | Cmc Project Manager |
|---|---|---|
| Credentials | Typically requires a Bachelor's degree in life sciences, engineering, or related field; often certifications like PMP or PgMP | Usually holds a Bachelor's degree in a relevant field; PMP certification is common |
| Work Environment | Oversees multiple projects within a program, coordinating cross-project activities in biotech or pharma industries | Manages individual projects, focusing on specific deliverables within the CMC scope |
| Employer & Industry | Pharmaceutical, biotech, or life sciences companies managing complex product development | Similar industry, often within the same companies, focusing on specific project execution |
The Cmc Program Manager oversees multiple related projects, ensuring alignment with strategic goals, while the Cmc Project Manager focuses on executing individual projects within the CMC domain. Both roles require similar credentials and work in the same industry, but differ in scope and responsibilities.
What are popular job titles related to Cmc Program Manager jobs in Maryland?
For Cmc Program Manager jobs in Maryland, the most frequently searched job titles are:
What job categories do people searching Cmc Program Manager jobs in Maryland look for?
The top searched job categories for Cmc Program Manager jobs in Maryland are:
What cities in Maryland are hiring for Cmc Program Manager jobs?
Cities in Maryland with the most Cmc Program Manager job openings:
Senior Manager, Global Regulatory Affairs, CMC
California, MD • On-site
Scorpion Therapeutics
• 51 - 200 employees51 - 200 employees
Other
Medical, Dental, Vision, Retirement, PTO
Posted 13 days ago
Job description
Brief Description:
#J-18808-Ljbffr- The Senior Manager, Regulatory Affairs Global CMC will manage registration and CMC regulatory support for commercial and/or development projects worldwide for biological products.
- Manage preparation/review of Module 2 and 3 CTD sections of regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, briefing documents) for biological products.
- Support Global CMC regulatory strategy for commercial and late/early-stage development programs.
- Perform risk assessments; identify and communicate potential strategy risks to multi-disciplinary and Global Regulatory teams.
- Coordinate and submit regulatory agency responses; manage timelines to ensure approvals and development objectives.
- Serve as regulatory CMC representative for business partner meetings; contribute to regulatory agency meetings for CMC issues.
- Ensure regulatory compliance via change control, regulatory information management, and regulatory impact assessments.
- Maintain current regulatory product information to support product release; verify electronic publishing of submissions.
- Identify and support continuous improvement opportunities.
- Ensure compliance with company policies, procedures, and training expectations.
- Strategic understanding and application of drug lifecycle regulations (preferably biological products).
- Solid CMC regulatory knowledge; ability to develop clear, well-argued positions.
- Experience with electronic CTD CMC documents (MAA, BLA, variations, responses, CTAs/INDs).
- Understanding of FDA, EMA, and ICH guidelines.
- Strong interpersonal skills working with internal teams and external partners/regulators.
- BSc/BA with regulatory CMC or related experience.
- Written and verbal English communication.
- Medical, dental, vision insurance; 401k; flexible paid vacation.
About Scorpion Therapeutics
Sourced by ZipRecruiter
Company size
51 - 200 Employees
Headquarters location
Boston, MA, US
Year founded
2020