Regulatory CMC Project Manager Job at Parexel

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

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

Regulatory Program Manager

Looking to oversee Regulatory Programs that could revolutionize the future of me...

Location

France , Paris

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Project management experience in the pharmaceutical industry
Strong understanding of CMC activities and interactions with regulatory and industrial teams
Ability to coordinate cross-functional teams

Job Responsibility

Leading product lifecycle management projects
Coordinating CMC, Regulatory, Supply, and Industrialization functions
Monitoring project milestones and cross-functional dependencies
Facilitating core team meetings, steering committee meetings and progress reporting

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

Associate Director, CMC Regulatory Affairs

Associate Director, CMC Regulatory Affairs (RA) who will work closely with our m...

Location

Canada , Vancouver

Salary:

141000.00 - 170000.00 CAD / Year

AbCellera Biologics

Expiration Date

Until further notice

Requirements

Deep understanding of CMC regulatory requirements, eCTD structure, and Module 3 preparation (BLAs/NDAs/NDSs) for biologics and combination products
Ability to navigate regulatory requirements for CMC submissions for biologics and combination products
Thorough understanding of Health Canada, FDA, and EMA regulations
Ability to efficiently oversee independent contractors and vendors
Skilled regulatory writer with effective oral communication skills
Detailed oriented, highly organized, and thrives in fast paced environments while managing multiple priorities
Relevant post-secondary degree(s) in biological, pharmaceutical, chemical, engineering sciences or a related field
About 12 years of relevant work experience

Job Responsibility

Serving as the primary CMC regulatory representative in project meetings and with regulatory agencies
Preparing CMC regulatory submissions including briefing documents, IND submissions, and CTA filings
Overseeing the preparation of responses to regulatory authority queries
Managing critical CMC regulatory timelines, working with team members to navigate the pathways for manufacturing and analytical development, working in close partnership with the CMC and Quality teams
Staying on top of detailed knowledge of the global regulatory environment relevant for biologics, communicating changing regulatory agency requirements, and supporting pertinent regulatory intelligence per needs of programs
Collaborating with external consultants, CDMOs, and CROs to provide regulatory guidance
Evaluating regulatory CMC program risks and establishing mitigation strategies pertinent to product development
Partnering with CMC, Discovery, and Clinical Development teams to innovate strategies to accelerate submission timelines

What we offer

Equity
Annual bonus dependent on team and company performance
6% (non-match) RRSP contribution
CAD $1,500 annual Active Lifestyle Allowance
Annual vacation
Professional development opportunities
Comprehensive health benefits
Scientific and technical mentorship

Fulltime

Director of RA CMC

About company: A pre-IPO biotech

Location

China , Shanghai

Salary:

1000000.00 - 1400000.00 CNY / Year

Randstad

Expiration Date

June 03, 2026

Requirements

Advanced degree (Ph.D. preferred, M.S. required) in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a related field
Minimum of 10 years of combined experience in CMC development (process, analytical, formulation) and Regulatory Affairs CMC within the pharmaceutical industry
Experience with device-drug combination products is a plus
Proven track record of successfully developing and implementing global CMC regulatory strategies from Phase 1 through approval
Extensive experience authoring CMC sections for major filings (IND/NDA) and leading health authority interactions
Comprehensive knowledge of US, EU, and ICH CMC guidelines
Must understand the scientific and technical nuances of oligonucleotide synthesis, purification, analytics, and stability
Outstanding written and verbal communication skills in English are mandatory
Demonstrated ability to think strategically, anticipate regulatory challenges, and develop innovative solutions
Strong leadership presence with the ability to influence and align cross-functional teams without direct authority

Job Responsibility

Regulatory CMC Strategy: Develop and execute comprehensive, proactive global CMC regulatory strategies for assigned programs from early development through marketing application and post-approval
Regulatory Submission Leadership: Serve as the Regulatory CMC Lead for major filings. Author, review, and critically assess high-quality CMC sections for all global regulatory submissions
Health Authority Interactions: Lead the preparation, coordination, and execution of all CMC-focused interactions with global health authorities
Expert Guidance on Complex Products: Act as the in-house subject matter expert on global regulatory CMC requirements for complex oligonucleotide-based products, including device-drug combination products
Strategic Liaison & Collaboration: Serve as the primary regulatory liaison between the CMC department and the broader Regulatory Affairs team

Fulltime

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

Senior Clinical Supplies Project Manager

Senior Clinical Supplies Project Manager ICON plc is a world-leading healthcare ...

Location

United Kingdom , Reading

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

3 - 4 years experience of working within a Clinical Supplies Project Management role
Degree ideal
Open to office, remote or hybrid working

Job Responsibility

Provides scientific, technical and regulatory support to projects that have significant Pharmaceutical Supply Management, Chemistry, Manufacturing and Control (CMC) activities associated with them
act as the lead on appropriate project teams
Manage global pharmaceutical supply for all phases and pharmaceutical development activities on-going at contract facilities with respect to technical, quality, timing and cost standpoint on behalf of our clients
Oversee labelling, packaging and distribution activities of CMO including review and approval of labelling/packaging records and distribution plans
Oversee recall, returns and destruction activities, as appropriate
Oversee the procurement of marketed drug product, such as comparators performed by an approved vendor and ensuring together with GRA/SSU that all study specific regulatory requirements are met
Perform Batch Record Review and Approval, as applicable
Manage temperature deviation, product complaints and recalls, as delegated by the client
Gap analysis of processes relating to pharmaceutical supplies for applicable project teams
Participates in the discussions of objectives and scope of prospective projects with potential clients

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

Fulltime

Regulatory CMC Project Manager

Parexel

Location:
United States

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 09, 2026

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