CrawlJobs Logo

CMC Project Management Specialist

enveda.com Logo

Enveda

Location Icon

Location:
United States

Category Icon
Category:
Research and Development

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided
Save Job
Save Icon
Apply Position

Requirements:

  • Experience with CMC project management in the biotech or pharma industry, specifically focusing on drug substance and drug product development
  • Experience leading cross-functional teams
  • Flexibility, adaptability, and resourcefulness
  • Willingness to work occasional early morning or late evening meetings to accommodate different time zones
  • Experience managing external CROs and CDMOs

Additional Information:

Job Posted:
February 17, 2026

Employment Type:
Fulltime
Work Type:
Remote work
Icon
Enveda - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for CMC Project Management Specialist

CMC Project Management Specialist

Join Enveda as a CMC Project Management Specialist in a remote capacity and help...
Location
Location
United States
Salary
Salary:
95000.00 - 115000.00 USD / Year
enveda.com Logo
Enveda
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • B.S./M.S./Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or similar degree
  • 1-2+ years of CMC project management experience in biotech or pharma, with exposure to drug substance and drug product development
  • Ability to manage cross-functional projects and communicate technical details clearly
  • Experience working with external CROs and CDMOs
Job Responsibility
Job Responsibility
  • Lead cross-functional planning and execution of CMC development activities across drug substance and drug product
  • Partner with internal and external teams to define and track development strategies, timelines, and deliverables
  • Oversee and monitor external CRO and CDMO activities, including planning, communication, and batch execution timelines
  • Develop and manage detailed CMC project plans, ensuring timely delivery through proactive communication and follow-up
What we offer
What we offer
  • 90% Medical, Dental, Vision
  • 401k Match
  • Flexible PTO
  • Adoption Assistance
  • Fulltime
Read More
Arrow Right

Senior Product Specialist, Regulatory Affairs

The Senior Regulatory Affairs Product Specialist serves as a key regulatory part...
Location
Location
United Kingdom , London
Salary
Salary:
Not provided
theramex.com Logo
Theramex
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Extensive experience with practical European Regulatory Affairs
  • Good understanding of MA lifecycle activities within DCP, MRP and National procedures (Post-authorisation variations, submission strategies, renewals, PSURs/PSUSAs)
  • Knowledge of CTD/eCTD documentation structure and lifecycle management
  • Knowledge of European regulations and related guidance documents for Regulatory submissions, Product Information authoring, CMC documentation, CTD and eCTD authoring
  • Able to perform other Regulatory Affairs activities with team support (e.g., PASS, PAMs, Centralised Procedure submissions)
  • Able to perform accompanying activities such as artwork reviews/approvals and Prescribing Information preparation
  • Good interpersonal skills and effective problem-solving capabilities
  • Proactive, adaptable and comfortable working across multiple projects while maintaining high standards
  • High attention to detail with excellent organisational and time-management skills
  • Excellent written and verbal communication skills in English
Job Responsibility
Job Responsibility
  • Preparation and submission of required regulatory packages for designated products/countries
  • Authoring/updating of key regulatory documentation including CTD components and Product Information
  • Development and implementation of regulatory strategy for required changes
  • Act as the contact within the business for regulatory advice and support related to designated products
  • Provide support and regulatory advice to key internal stakeholders
  • Identification of any gaps in the regulatory documentation and conduction of any remediation necessary to achieve compliance
  • Communication with external stakeholders, including regulatory agencies, CMO’s and third party service providers
  • Creation and maintenance of Regulatory Information Management systems and databases records and entries
  • Support of creation and maintenance of SOPs, working instructions describing regulatory and labelling processes and best practices to ensure compliance
What we offer
What we offer
  • 25 days holiday + 8 bank holidays
  • Private Health Insurance for employee and family members
  • Pension contribution: 10% company + 5% employee (auto-enrolled from day one)
  • Hybrid Working
  • Cycle to Work Scheme
  • Engaging employee experience to come together as a community: in-office events, shared learning and much more
  • Fulltime
Read More
Arrow Right

Drug Substance Senior Specialist – Biologics

We are seeking a Drug Substance Senior Specialist with strong experience in biol...
Location
Location
Denmark , København og omegn
Salary
Salary:
Not provided
life-science-talent-solutions.dk Logo
Life Science Talent
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Master’s degree in biotechnology, chemical engineering, pharmaceutical sciences, or related field
  • 8+ years of industry experience in biologics process development and validation, including collaboration with CDMOs
  • Proven experience with PPQ and process characterization for antibody drug substances
  • Solid understanding of ICH Q8–Q11 and global validation expectations
  • Practical knowledge of commercial-scale GMP operations, tech transfer, and regulatory submissions
  • Experience in early-stage process development and scale-up
  • Strong project management and organizational abilities
  • Excellent communication and technical writing skills for regulatory documentation
  • Collaborative mindset and ability to work effectively with external partners
  • Flexible, proactive, and comfortable operating in a fast-paced biotech environment
Job Responsibility
Job Responsibility
  • Support early-stage antibody programs by applying phase-appropriate development strategies
  • Collaborate with Quality, Regulatory, and Analytical teams to align on validation approaches
  • Provide technical input to CDMOs on process design, scale-up, and risk assessments
  • Plan and manage process performance qualification (PPQ) and characterization studies in partnership with CDMOs
  • Define and document CPPs, CQAs, and control strategies based on risk and data-driven insights
  • Ensure validation documentation (protocols, reports, summaries) complies with ICH Q8–Q11, FDA, and EMA expectations
  • Support implementation of continuous process verification (CPV) and lifecycle validation strategies
  • Oversee technology transfer to external manufacturing partners for commercial readiness
  • Contribute to CMC regulatory submissions (BLA/MAA) focusing on validation and control strategy
  • Coordinate comparability studies and process optimization activities with CDMOs
  • Fulltime
Read More
Arrow Right

Specialist I/II, Regulatory Affairs

The Regulatory Specialist will participate in the preparation of documentation p...
Location
Location
United States , Cambridge
Salary
Salary:
130000.00 - 160000.00 USD / Year
beamtx.com Logo
Beam Therapeutics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum BA/BS degree in a scientific/engineering discipline
  • 6+ years’ experience in the biotech industry
  • 8-10+ years’ experience in Regulatory CMC, or related experience (e.g., manufacturing, analytical, quality assurance) as a strong dossier preparation contributor for IND/CTA/MF and BLA/MAA submissions
  • Comprehensive knowledge of regulatory (FDA. EMA, and ICH) guidelines
  • with a demonstrated ability to articulate and apply these principles to regulatory CMC strategies for novel products
  • Strong experience with CTD format and content regulatory filings
  • Excellent organizational, written/oral communication, and time management skills
  • ability to communicate complex issues in a succinct and logical manner
  • strong listening skills
  • Experience with related CMC disciplines (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving
Job Responsibility
Job Responsibility
  • Able to prepare documentation packages for global regulatory submissions (including IND, CTA, Briefing Books, Scientific Advice, etc.) to the FDA and global regulatory agencies
  • Compiles documentation for submissions to FDA and global regulatory agencies
  • Support the development of regulatory strategies, risks and key issues in an evolving regulatory landscape
  • Support the develop regulatory processes and procedures of regulatory submissions
  • Develops and maintains collaborative partnerships with key internal and external stakeholders
  • Participate in regulatory intelligence activities, monitor regulatory guidelines and trends as they pertain to global regulations and guidance, and provide regulatory advice to project teams regarding the applicability/impact on internal programs
  • anticipate and communicate possible regulatory paradigm shifts
  • Fulltime
Read More
Arrow Right
New

Shift Supervisor

We're building a world of health around every individual — shaping a more connec...
Location
Location
United States , Houston
Salary
Salary:
16.50 - 24.00 USD / Hour
https://www.cvshealth.com/ Logo
CVS Health
Expiration Date
July 11, 2026
Flip Icon
Requirements
Requirements
  • Deductive reasoning ability, analytical skills and computer skills
  • Advanced communication skills and supervision skills
  • Ability to work a flexible schedule, including some early morning, overnight and weekend shifts, to work overtime as needed, and to respond to urgent issues at the store when they arise
  • High School diploma or equivalent preferred but not required.
Job Responsibility
Job Responsibility
  • Work effectively with store management and store crews
  • Supervise the store's crew through assigning, directing and following up of all activities
  • Effectively communicate information both to and from store management and crews
  • Assist customers with their questions, problems and complaints
  • Promote CVS customer service culture (Greet, offer help, and thank)
  • Handle all customer relations issues in accordance with company policy and promote a positive shopping experience for all CVS customers
  • Maintain customer/patient confidentiality
  • Price merchandise
  • Stock shelves
  • Execute the displays, sign and inventory of weekly, promotional, and seasonal merchandise
What we offer
What we offer
  • Dental
  • Vision
  • Wellness resources
  • Employee discounts
  • Access to certain voluntary benefits
  • Parttime
Read More
Arrow Right
New

Store Associate

Retail Store Associates play a meaningful role within the CVS Health family. At ...
Location
Location
United States , Mission Viejo
Salary
Salary:
16.90 - 23.90 USD / Hour
https://www.cvshealth.com/ Logo
CVS Health
Expiration Date
July 11, 2026
Flip Icon
Requirements
Requirements
  • At least 16 years of age
  • Previous experience in a retail or customer service setting
Job Responsibility
Job Responsibility
  • Providing differentiated customer service by anticipating customer needs, demonstrating compassion and care in all interactions, and actively identifying and resolving potential service issues
  • Focusing on the customer by giving a warm and friendly greeting, maintaining eye contact and offering help locating additional items, when needed
  • Accurately perform cashier duties - handling cash, checks and credit card transactions with precision while following company policies and procedures
  • Maintaining the sales floor by restocking shelves, checking in vendors, updating pricing information and completing inventory management tasks as directed by store manager
  • Supporting opening and closing store activities, when needed
  • Providing customer support to all departments, including photo and beauty, ensuring departments are fully stocked and operational while remaining current with all updated services and tools
  • Assisting pharmacy personnel when needed, including working regular shifts in the pharmacy as part of opportunities for growth and career development
  • Embracing and advocating for new CVS services and loyalty programs that support our purpose of helping people on their path to better health
What we offer
What we offer
  • Dental
  • Vision
  • Wellness resources
  • Employee discounts
  • Access to certain voluntary benefits
  • Other programs
  • Parttime
Read More
Arrow Right
New

Technology Third-Party Management, Senior Technical Business Analyst

The Technology Third-Party Management Senior Technical Business Analyst (IT Busi...
Location
Location
United States , Tampa
Salary
Salary:
Not provided
https://www.citi.com/ Logo
Citi
Expiration Date
May 22, 2026
Flip Icon
Requirements
Requirements
  • 6+ years of relevant experience
  • Hands-on experience with SaaS application configuration, including environment setup, role-based access, integrations, and ongoing optimization
  • Experience with Third-Party Management, Supplier Risk and Due Diligence controls
  • Knowledge of AI concept in the context of SaaS Applications
  • Comprehensive experience with both Agile deliveries using Jira, as well as all phases of the Software Development Life Cycle
  • Ability to handle a high volume of demands with flexibility
  • Experience participating in global team working
  • Specific ability to successfully produce in a functional systems organization is desirable
  • Knowledge of Citi policies and processes as it pertains to Third Party Management and Supplier Risk systems is a plus
  • Ability to develop strong relationships, negotiate areas of difference and build consensus across the global organization as well as with external suppliers, as appropriate
Job Responsibility
Job Responsibility
  • Oversight for delivery and enhancement, playing a key role in the implementation of part of the enterprise third party management platform, ARAVO
  • Responsible for the operational implementation, and management across integrated platforms, of business processes and appropriate automations, improvements to data quality, end-to-end systems integrations, and support the delivery of meaningful metrics
  • Design and implement appropriate controls in line with the Technology methodology
  • Carry out all required systems operations to ensure that the Technology System's objectives and goals are met
  • Develops and implements information management solutions to support ongoing systems operations and approved investment programs
  • Oversees components of the systems, such as data sourcing, data migration, data quality, solution design, team cross-functional training, user and centralized reporting, and implementation testing
  • Enhance system usability and overall user experiences through user support, hypercare, training and communication
  • Assist the business in process re-engineering, to yield throughput and productivity saves
  • Contribute to technical and business direction and strategic decisions as a technical expert in all development and implementation phases, providing in-depth and sophisticated analyses to define problems and develop innovative solutions
  • Establish relationships with stakeholders and mid-level management in various businesses to understand complex business drivers and provide system and metric/reporting support
What we offer
What we offer
  • medical
  • dental & vision coverage
  • 401(k)
  • life, accident, and disability insurance
  • wellness programs
  • paid time off packages, including planned time off (vacation), unplanned time off (sick leave), and paid holidays
  • discretionary and formulaic incentive and retention awards
  • Fulltime
Read More
Arrow Right
New

Store Associate

We’re building a world of health around every individual — shaping a more connec...
Location
Location
United States , Murrells Inlet
Salary
Salary:
15.00 - 18.00 USD / Hour
https://www.cvshealth.com/ Logo
CVS Health
Expiration Date
July 13, 2026
Flip Icon
Requirements
Requirements
  • At least 16 years of age
  • Remaining upright on the feet, particularly for sustained periods of time
  • Lifting and exerting up to 35 lbs of force occasionally, up to 10 lbs of force frequently, and a negligible amount of force regularly to move objects to and from, including overhead lifting
  • Visual Acuity - Having close visual acuity to perform activities such as: viewing a computer terminal, reading, visual inspection involving small parts/details
Job Responsibility
Job Responsibility
  • Providing differentiated customer service by anticipating customer needs, demonstrating compassion and care in all interactions, and actively identifying and resolving potential service issues
  • Focusing on the customer by giving a warm and friendly greeting, maintaining eye contact and offering help locating additional items, when needed
  • Accurately perform cashier duties - handling cash, checks and credit card transactions with precision while following company policies and procedures
  • Maintaining the sales floor by restocking shelves, checking in vendors, updating pricing information and completing inventory management tasks as directed by store manager
  • Supporting opening and closing store activities, when needed
  • Providing customer support to all departments, including photo and beauty, ensuring departments are fully stocked and operational while remaining current with all updated services and tools
  • Assisting pharmacy personnel when needed, including working regular shifts in the pharmacy as part of opportunities for growth and career development
  • Embracing and advocating for new CVS services and loyalty programs that support our purpose of helping people on their path to better health
What we offer
What we offer
  • dental
  • vision
  • wellness resources
  • employee discounts
  • access to certain voluntary benefits
  • other programs
  • Parttime
Read More
Arrow Right