CMC Project Manager Job at Life Science Talent (København)

Client Engagement Manager, CMC

Serve as a single point of contact for CCS (Connectivity Car Service) and Mobili...

Location

United States , Costa Mesa

Salary:

103170.00 - 158873.00 USD / Year

Hyundai AutoEver America

Expiration Date

Until further notice

Requirements

Bachelor's Degree or higher in a related field
5 + years of experience in a similar role such as client relationship/ key account management, preferably in the telematics, IT or automobile industry.
Consulting experience at a Big4 consulting company, highly desirable
Understanding of telematics services, fleet management, and connected vehicle solutions preferred.
Telecommunications experience preferred, with broad knowledge of various telecommunication products, services, networks, carriers, rate plans, contracts, and invoices
Ability to solve practical problems and deal with a variety of situations.
Ability to interpret difficult instructions, derive valid conclusions, and recommend reasonable courses of actions within the scope of the position.
Well organized with ability to pay close attention to details.
Strong interpersonal skills.
Able to collaborate effectively with cross-functional teams.

Job Responsibility

Serve as a single point of contact for CCS (Connectivity Car Service) and Mobility service-related inquiries and requests from clients and partners.
Facilitates and lead new service-related contract development / amendments with clients, HMG affiliates and partners.
Engage in all aspects of client and partner interactions, collaborate with the Procurement team to manage vendor contracts and relationships, creation/negotiation with client companies, coordinate with all internal departments for client proposal creation, and provide consulting service to client companies.
Lead various projects related to account management, client service, and partner management.
Create/manage customer pricing model align with company's strategic direction
Create/manage wireless usage forecast model based on new services and vehicle volume.
Manage subordinate Business Analysts, as applicable
Staying abreast of service implementation and business operation status, keep clients informed and stay up to date with their connectivity service status
Functions as a key advocate for Client Business Units (CBUs)
Serve as a single point of contact for connectivity service-related inquiries and requests from clients

Fulltime

Regulatory CMC Project Manager

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant field (e.g., Life Sciences, Regulatory Affairs, Project Management)
3+ years proven experience in regulatory affairs, particularly in CMC (Chemistry, Manufacturing, and Controls)
Strong project management skills with a track record of managing complex projects and meeting deadlines
Excellent organizational and communication skills
Excellent time management abilities
Proficient in Microsoft Office Suite
Proven experience with project management software ie. Smartsheet
Strong communication and interpersonal skills
Ability to work collaboratively in a fast-paced, dynamic environment
Must be able to work East Coast hours, regardless of physical location in Central or West Coast US time zones

Job Responsibility

Collaborative Coordination: Work closely with Regulatory CMC and Technical Development teams to prepare comprehensive tables of contents for CMC/Module 3 submission deliverables. This includes managing start/end timelines, identifying ownership, and tracking deliverables from authorship initiation through to approval, ensuring timely and high-quality submissions
Strategic Planning: Under the guidance of the Regulatory CMC Lead, develop and maintain a high-level global regulatory plan tracker. This tracker will illustrate the timing of key Regulatory CMC activities for the program, ensuring alignment with global regulatory requirements
Project Management: Serve as the project manager for meetings, adhering to best practices for meeting conduct and materials management. Ensure that all meetings are productive and that materials are well-organized and effectively managed
Regulatory Support: Assist in the preparation of materials for health authority engagements, ensuring that all documentation is thorough, accurate, and compliant with regulatory standards
Health Authority Engagement: Support the preparation of materials for health authority engagements

What we offer

Flexibility of working remotely
Part of a supportive and dynamic team
Supportive and inclusive environment
Opportunities for career growth
Flexible work arrangements
Diverse and global client exposure
Learn from experts

Cmc project manager i eds

ICON is looking for a CMC Project Manager I to join our Accelerated Pharmaceutic...

Location

United States , San Antonio

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

A minimum of 1 year experience in clinical, laboratory or project management role
Background in project management, preferably in a pharmaceutical setting
Familiarity with GMP regulations and compliance requirements
Excellent communication and interpersonal skills
Ability to effectively manage resources and prioritize tasks to meet project deadlines
Detail-oriented with strong organizational and problem-solving abilities
Bachelor or advanced degree in a relevant scientific field preferred, e.g. medicinal chemistry, organic chemistry, pharmaceutical sciences

Job Responsibility

Lead and manage multiple CMC projects from early development through commercialization
Coordinate cross-functional teams, including Analytical, Formulation Development, Manufacturing, Regulatory, and Quality Assurance
Review and authoring of relevant method validation, pharmaceutical analysis, QC reports and other relevant GMP documentation and deliverables
Develop and maintain detailed project plans, timelines, and risk assessments
Ensure compliance with global regulatory requirements, including FDA, EMA, and ICH guidelines
Act as the primary liaison between clients, internal teams, and third-party vendors to ensure alignment and timely execution of project deliverables
Work with planning to ensure that appropriate resources are available to complete the study to timeline
Proactively identify and address potential project risks, implementing effective mitigation strategies
Provide clear, timely, and professional communication to stakeholders regarding project progress, milestones, and potential challenges
Monitor project budgets and resource allocation to ensure efficient and cost-effective project execution and draft change order budget when scope changes occur

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Project Manager (Cloud)

We are looking for a Project Manager (Cloud) to take full ownership of end-to-en...

Location

Vietnam , Hà Nội

Salary:

Not provided

CMC Global Company Limited.

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Information Technology, Project Management, or a related field
Minimum 3 years of experience in IT project management, preferably in Cloud-based projects (infrastructure deployment, migration, DevOps, etc.)
Hands-on experience with at least one major cloud platform (AWS, Azure, or GCP)
Experience working in Agile/Scrum environments is a strong plus

Job Responsibility

Manage the full project lifecycle for cloud-related initiatives, ensuring timely and high-quality delivery within scope and budget
Collaborate with stakeholders to gather requirements, define solutions, develop implementation plans, and monitor project progress
Work closely with technical teams (DevOps, Cloud Engineers, Security, Developers, etc.) to ensure effective coordination and smooth execution
Build and manage project timelines, resources, risks, budgets, and quality metrics
Lead regular meetings with clients and internal teams to review progress, address challenges, and maintain transparency throughout the project
Report project performance, progress, and outcomes to senior management and stakeholders
Ensure all project activities comply with security standards, technical policies, and quality procedures of both CMC Global and the client

What we offer

Attractive compensation package: 14-month salary scheme plus annual bonus and additional allowances
Annual bonus package tailored based on performance and contribution
Young, open, and dynamic working environment that promotes innovation and creativity
Ongoing learning and development with regular professional training and opportunities to enhance both technical and soft skills
Exposure to cutting-edge technologies and diverse real-world enterprise projects
Vibrant company culture with regular team-building activities, sports tournaments, arts events, Family Day, and more
Full compliance with Vietnamese labor laws, plus additional internal perks such as annual company trips, special holidays, and other corporate benefits

Fulltime

Director, Global Regulatory Affairs (Submission Project Management)

The Director of Global Regulatory Affairs (Submission Project Management) is res...

Location

United States , Waltham

Salary:

175000.00 - 230000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

10+ years (8+ with advanced degree) of regulatory affairs and/or project management experience
Proven track record managing global submissions (NDA, BLA, MAA)
Deep expertise in the integrated drug development process, ensuring seamless progression from discovery through commercialization
Collaborated effectively across multidisciplinary teams to identify innovative solutions and alternatives, driving positive business outcomes
Expertly assessed and mitigated risk within a highly regulated environment, maintaining compliance while advancing critical projects
Strong project management skills (PMP certification a plus), with proficiency in Microsoft Project, SmartSheet, or Planisware
Excellent communication, organizational, and leadership abilities
Ability to thrive in a fast-paced, deadline-driven environment
Demonstrated negotiation and influence skills
Bachelor’s degree with regulatory and/or project management experience in the pharmaceutical industry

Job Responsibility

Contribute to and lead the execution of submission strategies in alignment with corporate objectives and regulatory requirements
Provide guidance on evolving global regulatory landscapes, including guidelines, regulations, and other factors related to regulatory filings
Lead and manage cross-functional submission team meetings and workstreams (Regulatory, Clinical, Quality, CMC, Medical Writing)
Oversee project team delivery of the marketing authorization applications
Liaising with regulatory operations department to ensure all components are identified on the submission content plans and submissions meet technical, formatting, and compliance standards
Develop and manage marketing authorization project timelines and deliverables
Identify risks and manage operational risks, implementing mitigation/contingency strategies to ensure submission success
Track progress and report status updates to executive leadership
Establish best practices and SOPs as needed for marketing application related submission processes
Ensure adherence to ICH, FDA, EMA, and other global regulatory regulations/guidelines

What we offer

Comprehensive health coverage
Flexible time off
Paid holidays
Year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Tuition reimbursement
Commuter benefits
Disability and life insurance
Annual bonus opportunities

Fulltime

Sr. CMC Project Manager

We are seeking a Sr. CMC Project Manager to join the Technical Operations Progra...

Location

United States

Salary:

160000.00 - 175000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree in science
5+ years of experience in biotech or pharmaceutical industry
3+ years of biologics development and manufacturing experience required
2+ years of Technical Operations/CMC experience
Experience working with clinical stage candidates across all phases of Clinical Development (e.g., Ph 1 to Ph 3)
Good technical knowledge of CMC development (Upstream, Downstream, Analytical), Supply Chain, CMC Regulatory Affairs, Quality, GMP requirements
Extensive knowledge of Smartsheet and Microsoft Timeline a must
Highly organized with meticulous attention to detail
Ability to multi-task and keep pace with a fast-moving organization
Ability to participate in calls across multiple international time zones

Job Responsibility

Lead the documentation flow between Tech Ops and our partners (CDMOs, external vendors) and maintain project documentation on SharePoint
Maintain and communicate a current overview of Tech Ops documentation status and issues, including weekly dashboards to present to the upper management
Responsible for migration of relevant Tech Ops documentation into the Veeva Quality System
Work with various Tech Ops teams to identify resource constraints, risks, and conflicts that could impact the team’s bandwidth
Provide Project Management support for one or more CMC programs, including building and maintaining the CMC timelines by interfacing with our external partners and facilitating cross-functional collaboration with the Tech Ops
Collaborate closely with the cross-functional Program Management team to ensure integration of Tech Ops activities into overall program plans, monitor project deliverables and ensure tasks are on track
Responsible for purchase order initiation in NetSuite, review and approval of vendor accruals and invoices
Responsible for tracking all outsourced activities

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Senior Manager, CMC Operations

Reporting to the Senior Director, CMC Operations, the Senior Manager, CMC Operat...

Location

United States , Waltham

Salary:

136000.00 - 170000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

8+ years of experience in pharmaceutical drug development and track record of success supporting multiple projects or programs simultaneously
Excellent communication/presentation skills and proficiency in Smartsheet software
Proven track record of creativity, problem solving, and productivity
Demonstrated success working in interdisciplinary and cross-functional teams
Comfortable working in a dynamic, interactive, fast-paced, and entrepreneurial environment
Bachelor’s degree in a scientific discipline

Job Responsibility

Drive Tech Ops, Quality, and Regulatory teams to ensure project priorities are clearly documented and communicated
Manage the CMC vendors to ensure all work is occurring according to the contracted scope, schedule, and budget
Responsible for the tracking of program budget and finances for CMC functions
Create and independently maintain project communication tools, such as CMC team meeting minutes, action tracking, and timeline plans
Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant stakeholders
Define and monitor progress on deliverables and provide timely updates to key stakeholders on project target dates and progress against goals
Actively manage relationships and communication between Kailera and external partners or service providers as required

What we offer

comprehensive health coverage
flexible time off
paid holidays
year-end shutdown
monthly wellness stipend
generous 401(k) match
tuition reimbursement
commuter benefits
disability and life insurance
annual bonus opportunities

Fulltime

Regulatory Project Manager

At GSK, we’re constantly developing new products and improving our established m...

Location

Poland , Poznan; Warsaw

Salary:

236250.00 - 393750.00 PLN / Year

GSK

Expiration Date

Until further notice

Requirements

Advanced degree (Master's or above) in Pharmacy, Biotechnology, Biology, Chemistry/Biochemistry or other closely related medical/life science field
Strong experience in CMC Regulatory Affairs within pharmaceutical industry or research organization
Extensive expertise in regulatory strategy planning, dossier preparation (CTD Module 1-3), technical dossier review and in all associated CMC regulatory aspects
Sound understanding of the pharmaceutical industry, drug development environment, regulatory processes and ICH guidelines and requirements, including EU regulatory framework
Exceptional flexibility, analytical thinking and growth mindset
Excellent interpersonal skills
including clear and effective written and verbal communication, and the ability to build strong relationships across a diverse, large organization
English writing skills
Excellent organizational skills, ability to handle multiple tasks, prioritize effectively and deliver high quality output under imposed deadlines, with a strong attention to detail (with emphasis on accuracy and completeness)

Job Responsibility

Take ownership for multiple complex CMC regulatory submissions, including planning, coordination and execution, to support applications for marketing authorizations, lifecycle activities and maintenance of registered products across Vaccines portfolio, in accordance with the applicable regulatory and scientific standards
Manage multiple project assignments simultaneously, including CMC variations and handling Health Authority Questions (HAQs) for Finished Products, Intermediates, and Active Pharmaceutical Ingredients for Vaccines products (i.e. largely involving updates to the CTD Module 3, Quality section of the dossiers)
Identify risks associated with submission data and information package
and support the development of mitigation strategies
Collaborate closely with cross-functional teams, such as Global Regulatory Lead’s team, Global Supply Chain (GSC), Quality Assurance (QA), Local Operating Companies (LOCs), and third Parties to build regulatory CMC submissions and maintain strong relationships, including with senior stakeholders
Identify improvement opportunities for CMC Regulatory processes, policies, instructions and systems, developing and implementing simplified working practices and procedures to enhance efficiency and quality
Serve as Subject Matter Expert (SME) for CMC Regulatory Affairs, mentoring and guiding team members, while sharing best practices to build capability and knowledge within the CMC Regulatory teams and other impacted functions

What we offer

private healthcare
additional paid days off
life insurance
private pension plan
fully paid parental leave & care of family member leave

Fulltime

CMC Project Manager

Life Science Talent

Location:
Denmark , København

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 25, 2026

Expiration:
February 09, 2026

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

Similar Jobs for CMC Project Manager

Client Engagement Manager, CMC

Regulatory CMC Project Manager

Cmc project manager i eds

Project Manager (Cloud)

Director, Global Regulatory Affairs (Submission Project Management)

Sr. CMC Project Manager

Senior Manager, CMC Operations

Regulatory Project Manager

CMC Project Manager

Life Science Talent

Location:Denmark , København

Category:Research and Development

Contract Type:Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:January 25, 2026

Expiration:February 09, 2026

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

Similar Jobs for CMC Project Manager

Client Engagement Manager, CMC

Regulatory CMC Project Manager

Cmc project manager i eds

Project Manager (Cloud)

Director, Global Regulatory Affairs (Submission Project Management)

Sr. CMC Project Manager

Senior Manager, CMC Operations

Regulatory Project Manager

Location:
Denmark , København

Category:
Research and Development

Contract Type:
Not provided

Job Posted:
January 25, 2026

Expiration:
February 09, 2026