Manager, Regulatory CMC
Somerset, NJ · Hybrid
Partner closely with Regulatory CMC Program Leads and cross-functional subject matter experts to ... Strong project management and organizational skills. * Ability to manage multiple programs and ...
Manager, Regulatory CMC
Somerset, NJ · Hybrid
Partner closely with Regulatory CMC Program Leads and cross-functional subject matter experts to ... Strong project management and organizational skills. * Ability to manage multiple programs and ...
Manager, Regulatory CMC
Somerset, NJ · On-site
Partner closely with Regulatory CMC Program Leads and cross-functional subject matter experts to ... Strong project management and organizational skills. * Ability to manage multiple programs and ...
Manager, Regulatory CMC
Somerset, NJ · On-site
Partner closely with Regulatory CMC Program Leads and cross-functional subject matter experts to ... Strong project management and organizational skills. * Ability to manage multiple programs and ...
Partner closely with Regulatory CMC Program Leads and cross-functional subject matter experts to ... Strong project management and organizational skills.Ability to manage multiple programs and ...
Partner closely with Regulatory CMC Program Leads and cross-functional subject matter experts to ... Strong project management and organizational skills.Ability to manage multiple programs and ...
They guide CMC program teams by articulating the impact of trade-offs and residual risks, and ... Strong project leadership, communication, and stakeholder-management skills in a fast-paced ...
They guide CMC program teams by articulating the impact of trade-offs and residual risks, and ... Strong project leadership, communication, and stakeholder-management skills in a fast-paced ...
Senior Director, CMC Regulatory
Princeton, NJ · On-site
$157K - $207K/yr
Proactively manage regulatory CMC aspects of programs to ensure on-time delivery of global, high-quality submissions across all development-stage programs * Manage regulatory interactions with global ...
Senior Director, CMC Regulatory
Princeton, NJ · On-site
$157K - $207K/yr
Proactively manage regulatory CMC aspects of programs to ensure on-time delivery of global, high-quality submissions across all development-stage programs * Manage regulatory interactions with global ...
Product Development Program Manager
$118K - $147K/yr
... CMC, Manufacturing, Quality, Commercial, and Finance functions. Accountable for the efficient and ... Maintains core program management deliverables, including integrated timelines, resource plans ...
Quick apply
Product Development Program Manager
$118K - $147K/yr
... CMC, Manufacturing, Quality, Commercial, and Finance functions. Accountable for the efficient and ... Maintains core program management deliverables, including integrated timelines, resource plans ...
Product Development Program Manager
Warren, NJ · On-site
$118K - $147K/yr
... CMC, Manufacturing, Quality, Commercial, and Finance functions. Accountable for the efficient and ... Maintains core program management deliverables, including integrated timelines, resource plans ...
Product Development Program Manager
Warren, NJ · On-site
$118K - $147K/yr
... CMC, Manufacturing, Quality, Commercial, and Finance functions. Accountable for the efficient and ... Maintains core program management deliverables, including integrated timelines, resource plans ...
Senior Director, CMC Regulatory
Princeton, NJ · On-site
$241K - $300K/yr
Proactively manage regulatory CMC aspects of programs to ensure on-time delivery of global, high-quality submissions across all development-stage programs * Manage regulatory interactions with global ...
Senior Director, CMC Regulatory
Princeton, NJ · On-site
$241K - $300K/yr
Proactively manage regulatory CMC aspects of programs to ensure on-time delivery of global, high-quality submissions across all development-stage programs * Manage regulatory interactions with global ...
The role partners closely with technical, quality, supply and program teams to communicate ... Track, manage, and coordinate multiple CMC regulatory project timelines, aligning ongoing ...
The role partners closely with technical, quality, supply and program teams to communicate ... Track, manage, and coordinate multiple CMC regulatory project timelines, aligning ongoing ...
The role partners closely with technical, quality, supply and program teams to communicate ... Track, manage, and coordinate multiple CMC regulatory project timelines, aligning ongoing ...
The role partners closely with technical, quality, supply and program teams to communicate ... Track, manage, and coordinate multiple CMC regulatory project timelines, aligning ongoing ...
The role partners closely with technical, quality, supply and program teams to communicate ... Track, manage, and coordinate multiple CMC regulatory project timelines, aligning ongoing ...
The role partners closely with technical, quality, supply and program teams to communicate ... Track, manage, and coordinate multiple CMC regulatory project timelines, aligning ongoing ...
Director, Regulatory Affairs CMC
Princeton, NJ · On-site
$157K - $207K/yr
This is an opportunity to make a meaningful impact on programs that bring important therapies to patients around the world. Primary Responsibilities * Manages the CMC regulatory affairs activities ...
Director, Regulatory Affairs CMC
Princeton, NJ · On-site
$157K - $207K/yr
This is an opportunity to make a meaningful impact on programs that bring important therapies to patients around the world. Primary Responsibilities * Manages the CMC regulatory affairs activities ...
Proficient in Electronic Document Management Systems * Ability to work with firm deadlines and ... This position may need to sit for long periods of time and use various computer programs. * This ...
Proficient in Electronic Document Management Systems * Ability to work with firm deadlines and ... This position may need to sit for long periods of time and use various computer programs. * This ...
Proficient in Electronic Document Management Systems * Ability to work with firm deadlines and ... This position may need to sit for long periods of time and use various computer programs. * This ...
Proficient in Electronic Document Management Systems * Ability to work with firm deadlines and ... This position may need to sit for long periods of time and use various computer programs. * This ...
Director Regulatory Affairs (CMC)
Princeton, NJ · On-site
$158K - $209K/yr
... design of CMC components of drug development programs in collaboration with counterparts ... to the executive management. * Lead all RA-CMC operations through all phases of clinical ...
Quick apply
Director Regulatory Affairs (CMC)
Princeton, NJ · On-site
$158K - $209K/yr
... design of CMC components of drug development programs in collaboration with counterparts ... to the executive management. * Lead all RA-CMC operations through all phases of clinical ...
Proficient in Electronic Document Management Systems * Ability to work with firm deadlines and ... This position may need to sit for long periods of time and use various computer programs. * This ...
Proficient in Electronic Document Management Systems * Ability to work with firm deadlines and ... This position may need to sit for long periods of time and use various computer programs. * This ...
Proficient in Electronic Document Management Systems * Ability to work with firm deadlines and ... This position may need to sit for long periods of time and use various computer programs. * This ...
Proficient in Electronic Document Management Systems * Ability to work with firm deadlines and ... This position may need to sit for long periods of time and use various computer programs. * This ...
Proficient in Electronic Document Management Systems * Ability to work with firm deadlines and ... This position may need to sit for long periods of time and use various computer programs. * This ...
Proficient in Electronic Document Management Systems * Ability to work with firm deadlines and ... This position may need to sit for long periods of time and use various computer programs. * This ...
Proficient in Electronic Document Management Systems * Ability to work with firm deadlines and ... This position may need to sit for long periods of time and use various computer programs. * This ...
Proficient in Electronic Document Management Systems * Ability to work with firm deadlines and ... This position may need to sit for long periods of time and use various computer programs. * This ...
$166K - $220K/yr
Manages the development and preparation of high-quality regulatory submissions including NDA's, MAA ... programs. Keep abreast of current global regulations and guidelines. Perform other duties as ...
$166K - $220K/yr
Manages the development and preparation of high-quality regulatory submissions including NDA's, MAA ... programs. Keep abreast of current global regulations and guidelines. Perform other duties as ...
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 New Jersey?
For Cmc Program Manager jobs in New Jersey, the most frequently searched job titles are:
What job categories do people searching Cmc Program Manager jobs in New Jersey look for?
The top searched job categories for Cmc Program Manager jobs in New Jersey are:
What cities in New Jersey are hiring for Cmc Program Manager jobs?
Cities in New Jersey with the most Cmc Program Manager job openings:
Manager, Regulatory CMC
Somerset, NJ • Hybrid
Legend Biotech US
• Biotechnology Research and Development • 1 - 5K employees1,001 - 5,000 employees
Full-time
Posted 21 days ago
Legend Biotech rating
9.2
Based on 6 frontline employees who took The Breakroom Quiz
Job description
Legend Biotech is seeking a Manager, Regulatory CMC as part of the Regulatory Affairs team based in Somerset, NJ.
Role Overview
This position will support the development and execution of global CMC regulatory strategies for pipeline programs, with a strong focus on regulatory dossier authoring and cross-functional collaboration to advance product development milestones.
Key Responsibilities
- Support the development and execution of global CMC regulatory strategies for pipeline cell and gene therapy programs, including CAR-T and lentiviral vector products.
- Partner closely with Regulatory CMC Program Leads and cross-functional subject matter experts to plan, prepare, review, and coordinate CMC components of global regulatory submissions, including INDs, CTAs, BLAs, MAAs, amendments, supplements, and responses to Health Authority requests.
- Author, review, and maintain high-quality CMC regulatory documentation to support global development, registration, and commercialization activities, ensuring compliance with applicable regulatory requirements and company standards.
- Collaborate with cross-functional technical teams, including Process Development, Manufacturing,
- Analytical Development, and Quality, to understand complex CMC information and effectively translate it into clear, scientifically sound regulatory submissions.
- Evaluate and interpret technical documentation, including development reports, validation protocols and reports, comparability assessments, and manufacturing change packages, to support regulatory impact assessments, submission strategies, and regulatory decision-making.
Requirements
- Bachelor's degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, Biochemistry, Chemistry, Engineering, or related discipline required. Advanced degree (MS, PhD, PharmD) preferred.
- 5+ years of biotechnology or pharmaceutical industry experience with strong technical background.
- Minimum of 1-2 years of Regulatory CMC experience supporting biologics, cell and gene therapy products, or extensive experience authoring and managing CMC sections of regulatory dossiers and submissions.
- Experience working with process development, analytical development, or manufacturing teams.
- Experience supporting cell and gene therapies highly preferred.
- Familiarity with global regulatory requirements, including FDA, EMA, and ICH guidelines.
- Strong scientific understanding and technical background on biologics or cell and gene therapy products.
- Excellent technical writing and document preparation skills with demonstrated experience authoring regulatory submission content.
- Ability to critically review and interpret scientific and technical data and translate complex information into clear regulatory documentation.
- Strong project management and organizational skills.
- Ability to manage multiple programs and competing priorities in a fast-paced environment.
- Strong communication and collaboration skills with cross-functional stakeholders.
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About Legend Biotech
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
1,001 - 5,000 Employees
Headquarters location
Somerset, NJ, US