CMC Manager Job at Alliance Medical Ltd (Guildford)

Senior Manager - CMC Regulatory Affairs Biopharm Development Projects

This position is responsible for leading CMC regulatory activities for investiga...

Location

United States; Belgium; Italy; United Kingdom , Collegeville; Wavre; Durham; Siena; London; Waltham

Salary:

144375.00 - 240625.00 USD / Year

GSK

Expiration Date

Until further notice

Requirements

Bachelor's degree in Life Sciences or related field
Four or more years of experience in drug development and manufacturing and supply processes and may have a specialized area of expertise
Four or more years of experience interpreting and executing complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment
Two or more years of experience completing project management tasks.

Job Responsibility

Drives the CMC strategy coordinates the timely preparation and authors, as needed, technical (CMC) regulatory documents to support development/registration/lifecycle maintenance submission content, in accordance with the applicable regulatory & scientific standards, and taking into account the evolving regulatory requirements
Identifies risks to the business associated with submission data and information packages and provides and communicates well defined risk mitigation strategies
Mentors or trains staff
May have direct line management responsibility
Manages project activities for multiple complex projects and teams simultaneously, including those for reporting staff as appropriate
Provides strategic direction, data assessment and conclusions within and across departments
Able to establish organisational networks (internal and external understanding departmental constraints/pressure within a highly complex organisation
Engages and may lead CMC Subject Matter Expert activities, both internally (for increased compliance, harmonisation and efficiency) and externally (external advocacy and shaping the regulatory environment)
May deliver CMC regulatory strategy to support major inspections (e.g. PAI's) or quality incidents (PIRCs)
Has accountability for submission content

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes
Health care and other insurance benefits (for employee and family)
Retirement benefits
Paid holidays
Vacation

Fulltime

Regulatory Affairs Manager (CMC)

The RA CMC Manager is responsible for execution and/ or coordination of global r...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree OR Master’s degree and 3 years of directly related experience OR Bachelor’s degree and 5 years of directly related experience
Experience in manufacture, testing (QC/QA or clinical), or distribution
Regulatory CMC experience

Job Responsibility

Generate and execute global and country-specific regulatory strategies
Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments
Develop global dossiers for CMC content for initial submissions, variations and amendments
Support change management activities
Develop response strategy and respond to health authority questions
Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans
Liaise with local regulatory teams to align on filing strategy
Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current
Maintain submission information according to the Regulatory Information Management (RIM) system
Follow established department regulatory processes to ensure cross-product alignment

Fulltime

Senior CMC Manager, MSAT (Biologics)

Hansa Biopharma is seeking an experienced Manufacturing Science & Technology exp...

Location

Sweden , Lund

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

M.Sc (or equivalent) in Pharmaceutical Sciences, Biochemistry, Biotechnology, Chemistry, Engineering, or related life science field
Typically, 8+ years of experience in GMP manufacturing of biologics
Demonstrated in-depth scientific understanding of biologics manufacturing processes (e.g., recombinant proteins, enzymes, monoclonal antibodies or similar)
Extensive experience supporting both clinical development and commercial manufacturing
Solid hands-on experience working within GMP-regulated quality systems
Proven track record in oversight of CDMOs/CMOs in a virtual or outsourced manufacturing structure
Experience interacting with global health authorities and supporting regulatory inspections
Strong understanding of regulatory expectations for biologics throughout the product lifecycle
Excellent communication skills in English

Job Responsibility

Act as the recognized internal SME for CMC Quality related to biologics and GMP compliance for biological drug substance and drug product manufacturing
Strengthen and continuously improve CMC quality systems, promoting a proactive, science-based, and compliance-driven quality culture while identifying process improvement opportunities
Coordinate and manage deviation investigations, change controls, CAPAs, and risk assessments
Contribute to, and support, interactions with regulatory authorities (e.g., FDA, EMA)
Review and approve Master Batch Records, protocols, validation documentation, and technical reports
Provide robust quality oversight of CDMOs, CMOs, and CROs, including supplier qualification, performance monitoring (KPIs), and continuous improvement initiatives
Act as vendor responsible and perform periodic Vendor review
Contribute to the establishment and maintenance of Quality Agreements

Fulltime

Senior Global CMC Manager (Development & Lifecycle)

Karo Healthcare, a dynamic and growing personal-care retail company, is all abou...

Location

Sweden , Stockholm

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

University degree in Life Sciences
Strong understanding of regulatory requirements and applicable legal frameworks for pharmaceutical products
Proven CMC expertise covering the full product lifecycle, including post-approval development and manufacturing-related changes
Extensive experience in variation management, including the development and execution of regulatory and CMC strategies
Experience with EU regulatory procedures (primarily national, as well as DCP and MRP), with exposure to additional markets considered an advantage
Demonstrated experience working at the interface between Regulatory CMC, R&D CMC, and Manufacturing for commercialised pharmaceutical products
Hands-on experience with CMC Module 3 authoring, review, and lifecycle maintenance
Solid understanding of pharmaceutical manufacturing processes, formulation principles, APIs, and CMO-based supply models
Proven ability to work cross-functionally with Regulatory Affairs, Quality, Manufacturing, Supply Chain, Commercial functions, and external partners
Experience interacting with regulatory authorities and maintaining effective professional relationships

Job Responsibility

Act as global CMC Module 3 owner throughout the product lifecycle, ensuring scientific consistency and alignment with the actual manufacturing processes, formulation, APIs, control strategies, and implemented post-approval changes
Manage and maintain the CMC (Module 3) components of global and local dossiers, including technical preparation and compilation of CMC documentation to support regulatory submissions and lifecycle maintenance, with particular responsibility for legacy products
Ensure timely implementation of approved CMC changes within defined scope, including verification that Module 3 documentation and internal systems reflect Health Authority approvals
Assess and lead regulatory CMC evaluation of proposed changes, including technical impact assessment, variation classification, and identification of required documentation in alignment with applicable EU and relevant market requirements
Review and approve regulatory CMC documentation for submissions and lifecycle changes in compliance with applicable regulatory requirements and internal regulatory information and document management systems
Initiate and maintain CMC-related regulatory events and documentation within the regulatory information management system (e.g., Veeva RIM) in accordance with internal procedures
Maintain a current understanding of relevant CMC-related regulations, guidelines, and standards, as well as established and emerging manufacturing and development practices applicable to commercialised pharmaceutical products
Lead CMC strategy development for assigned products across development and lifecycle phases, providing aligned CMC input to regulatory strategy discussions, technical risk assessments, gap analyses, and the evaluation and implementation of lifecycle changes
Apply in-depth knowledge of CMC Module 3 as a practical lifecycle tool to support and drive technical and regulatory decision-making related to manufacturing and post-approval development activities
Act as a technical and regulatory CMC counterpart towards manufacturing CMOs, developing a sound understanding of their manufacturing operations and providing appropriate scientific input, guidance, and challenge as required

What we offer

Opportunity to create, grow, and encourage
Apart from a competitive salary pack, there are lots of growth opportunities to meet your personal ambitions
Flexible schedule, hybrid model with the primary work place in the office, and life-work balance
Responsibility for exciting and challenging projects that have a direct, visible impact on our customers and the industry
Very positive work environment in a dynamic, international, and motivated team
Start-up spirit while being a part of the large international organization with strong values

Fulltime

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

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

CMC Development Manager

As a CMC Development Manager, you'll take full ownership of CMC (Chemistry, Manu...

Location

Sweden , Stockholm

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

MSc or PhD in Pharmaceutics, Chemistry, Chemical Engineering, Biology, or related field
5+ years of experience in pharmaceutical formulation, process development, or CMC project management
Deep understanding of API characteristics, QbD principles, and GMP/ICH standards
Proven ability to lead cross-functional CMC workstreams and manage external partners (CMOs/CDMOs)
Strong experience in global regulatory submissions (EU
US is a plus)
Excellent technical writing, communication, and stakeholder management skills
Experience in lean or virtual pharma models and post-approval lifecycle management preferred
Curious, proactive, and collaborative - able to thrive in an agile, fast-moving international environment

Job Responsibility

Lead the end-to-end execution of CMC projects for topical and oral solid dosage forms — from formulation and process design to scale-up and lifecycle management
Translate API properties into formulation and process design criteria
Develop, optimize, and troubleshoot robust formulations and manufacturing processes
Oversee scale-up, validation, and tech transfer activities with CMOs and CDMOs
Author and review CMC documentation including development reports, process descriptions, and validation summaries
Own and ensure scientific integrity of CTD Module 3 content, supporting global submissions and lifecycle variations
Partner with Regulatory Affairs to define submission strategies, timelines, and responses
Drive cross-functional alignment with QA, RA, Supply Chain, and CMOs to ensure timely and compliant CMC delivery
Manage CMC project plans, risk registers, and key milestones for assigned product portfolios

What we offer

Opportunity to create, grow, and encourage
Apart from a competitive salary pack, there are lots of growth opportunities to meet your personal ambitions
Flexible schedule, hybrid model with the primary work place in the office, and life-work balance
Responsibility for exciting and challenging projects that have a direct, visible impact on our customers and the industry
Very positive work environment in a dynamic, international, and motivated team
Start-up spirit while being a part of the large international organization with strong values

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

Select Country

CMC Manager

Job Description

Job Responsibility

Requirements

What we offer

Looking for more opportunities?

CMC Manager

Senior Manager - CMC Regulatory Affairs Biopharm Development Projects

Regulatory Affairs Manager (CMC)

Senior CMC Manager, MSAT (Biologics)

Senior Global CMC Manager (Development & Lifecycle)

Client Engagement Manager, CMC

Senior Manager, CMC Operations

CMC Development Manager

Regulatory CMC Project Manager

Our AI answers in your language