CMC Regulatory Consultant Job at CK Group (Munich)

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

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

Regulatory Affairs Consultant

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

Location

United States , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

4–6 years of CMC regulatory experience in the pharmaceutical industry for a Consultant level role, 7+ years for a Senior Consultant
Proven success in preparing regulatory documentation for FDA, EMA, and Health Canada (IND, NDA, DMF)
In-depth understanding of drug development, manufacturing processes, GMP, and regulatory frameworks for small molecules and biologics
Strategic and proactive mindset with strong operational execution
Excellent analytical, problem-solving, and negotiation skills
Effective communicator with strong interpersonal, presentation, and leadership abilities
Ability to manage multiple projects independently in a matrixed, multicultural environment
Proficiency in Microsoft Office Suite and regulatory systems
Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or related field
Advanced degrees (Pharm.D., M.S., Ph.D.) in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology preferred

Job Responsibility

Provide regulatory strategy input for small molecule and biologic products
Support regulatory leads in developing contingency plans for CMC-related scenarios
Represent CMC Regulatory Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global regulatory leads
Prepare, coordinate, and review CMC and GMP-related documents for regulatory submissions
Develop CMC strategies for products across all phases—from early development to marketing applications and post-approval changes
Partner with manufacturing, quality, and external organizations to address CMC-related issues
Maintain collaborative relationships with internal stakeholders, affiliates, contract manufacturers, packagers, and suppliers
Support planning and execution of Health Authority meetings, including mock sessions
Identify and implement process improvements to enhance regulatory efficiency and readiness
Participate in monthly CMC Global Regulatory Team meetings to align strategies across functions

What we offer

Flexible work arrangements
Opportunities for career growth
Supportive and inclusive environment
Diverse and global client exposure
Learn from experts

Fulltime

Regulatory Affairs Consultant - CMC vax/bio (home or office based)

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

Location

United Kingdom

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

University-level education, preferably in Life Sciences, or equivalent by experience
Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry
Strong understanding of CMC and post-approval regulatory requirements
Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations
Knowledge of vaccines or biological processes - must
Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation
Understanding of qualification/validation principles
Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued
Team spirit, flexibility, accountability, and organizational skills
Fluent in English (written and spoken)

Job Responsibility

Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports
Assess change controls and provide regulatory assessments of quality changes in production and quality control
Review study reports from the quality control and production departments to ensure compliance with regulatory requirements
Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies
Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities
Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions
Identify, escalate, and mitigate risks associated with regulatory procedures and activities

What we offer

Flexible work arrangements

Fulltime

Regulatory Affairs Consultant

Join our team and start a new adventure in an international and dynamic environm...

Location

Italy , Latina

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

Experience in regulatory affairs with a focus on CMC for sterile pharmaceutical products
Experience in Quality Assurance, specifically in sterility assurance
Experience with Biotech products and API manufacturing is a plus
Experience in preparing and submitting CTD dossiers for the US market (BLA), minimum 10 years
Experience in international registrations (non-CTD) and GMP Clearances/PMF for Asia and Africa markets
Academic background: scientific degree (e.g., Pharmacy, Chemistry, Biology) preferred
Fluent English and Italian
You demonstrate strong analytical and communication skills

Job Responsibility

Prepare and review regulatory dossiers in CTD format for the US market (BLA)
Manage regulatory submissions and communications for sterile products, including Biotech and API manufacturing
Oversee international product registrations, including non-CTD formats and GMP Clearances/PMF for Asia and Africa markets
Ensure compliance with global regulatory requirements for sterile pharmaceutical products
Collaborate with Quality Assurance teams, focusing on sterility assurance
Support regulatory strategy development for new and existing products
Liaise with cross-functional teams to gather and validate documentation for regulatory submissions
Monitor and interpret changes in regulatory guidelines impacting sterile and biotech products

What we offer

An international community, bringing together 110+ different nationalities
An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
A robust training system with our internal Academy and 250+ available modules
A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)
At Mantu, sustainability is part of everything we do. You’ll have the opportunity to turn your ideas into action and make a tangible impact. Every day, our teams bring our ESG commitments to life, from reducing our footprint to driving positive change within our communities. Through our WeCare Together program, you’ll be empowered to design and lead projects that create real social or environmental impact, with the company’s full support

Fulltime

Regulatory Publishing Expert/Lead

As a Regulatory Publishing Expert/Lead at ProductLife Group, you will ensure com...

Location

United States

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

Bachelor’s degree (BA/BS) in Life Sciences or related field (advanced degree a plus)
8–10+ years of hands-on regulatory publishing experience in pharma/biotech or consulting (global programs
NDA/BLA/MAA experience a plus)
Proficiency with electronic publishing software (e.g., Lorenz DocuBridge, EXTEDO), including configuration, software updates, and user administration
Deep familiarity with eCTD standards, GxPs, current regulatory guidance/legislation, and industry trends impacting submissions
High proficiency in Microsoft Word, Excel, Project, PowerPoint, and Adobe Acrobat Pro (templates, styles, bookmarking/hyperlinking, forms, advanced PDF)
Strong command of eCTD validation tools and agency gateways/portal processes

Job Responsibility

End-to-end eCTD/electronic submission publishing for initial and life-cycle submissions (e.g., INDs, NDAs, BLAs, DMFs), including structure build, validation, finalization, and dispatch to agencies/portals
Operational ownership of publishing platforms (e.g., Lorenz DocuBridge, EXTEDO)—version upgrades, user acceptance testing (UAT), license/access administration, and vendor liaison
Maintenance of validated systems: change control, periodic review, and documentation to ensure continuous inspection readiness (QMS, SOPs, WI, templates)
Workload planning & delegation across internal publishers and PLG partners/contractors
balancing priorities and reallocating work to hit critical milestones
People leadership of direct reports (Publishers): onboarding, coaching, capability building, and performance management (goals, feedback, development plans)
Quality oversight: enforce GxP and publishing best practices
lead pre-submission QC, eCTD validation, and issue resolution for complex/variable factors
Cross-functional collaboration with Regulatory Affairs, CMC, Clinical, QA, and external clients to drive on-time, right-first-time submissions
Business development support: participate in client-facing BD meetings, provide scope inputs, and support contracting for new, renewal, and extension work

Fulltime

Senior Regulatory Affairs Consultant

ProductLife Group (PLG) is a global life sciences consulting and outsourcing par...

Location

United States

Salary:

170000.00 - 210000.00 USD / Year

Product Life Group

Expiration Date

Until further notice

Requirements

Bachelor’s degree (BA/BS) in a relevant scientific discipline
10–15 years of Regulatory Affairs experience, with strong U.S. FDA exposure
Proven experience in independent development and execution of U.S. FDA regulatory strategies
Proven experience in authoring and leading INDs, NDAs, BLAs, amendments, and HA meeting packages
Proven experience in direct Health Authority interactions as Sponsor Representative
Strong working knowledge of FDA regulations and guidance
Strong working knowledge of ICH guidelines
Strong working knowledge of global regulatory frameworks
Demonstrated cross-functional regulatory leadership
Experience across multiple development stages (early development through registration)

Job Responsibility

Provide regulatory strategic and tactical leadership for biotech and pharma programs across development stages
Serve as Regulatory Lead / Advisor and project or program leader for multiple client engagements
Lead cross-functional teams (Clinical, CMC, Nonclinical) across multiple indications and product types
Develop and drive regulatory strategies, integrated development plans, and key regulatory documents
Coordinate, author, review, and manage Health Authority meeting packages
Coordinate, author, review, and manage special designation requests
Coordinate, author, review, and manage regulatory submissions (INDs, NDAs, BLAs, amendments)
Lead and represent clients in formal FDA interactions, including acting as Authorized Sponsor Representative
Lead and represent clients in formal FDA interactions, including preparing and coaching clients for Health Authority meetings
Interpret and apply FDA regulations, ICH guidelines, and global regulatory frameworks

Fulltime

Consultant - Peptide DS Manufacturing & Formulation Development

Are you ready to make a groundbreaking impact in the world of biotechnology? Joi...

Location

France , Paris

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Significant experience (10+ years) in peptide drug development, including leading DS/DP programmes and managing CDMOs
Deep expertise in synthetic peptides (chemical synthesis) and strong working knowledge of peptide process development and scale up
Strong background in formulation development for preclinical/clinical studies, including support for GLP tox and clinical readiness
Strong understanding of regulatory and quality frameworks (GMP
quality systems), with proven ability to produce high quality technical/regulatory documentation
Fluent French & English (onsite team integration and cross functional working are essential)
Able to work minimum 3 days/week onsite in the Paris area and travel to CDMO sites as needed

Job Responsibility

Lead process transfer, process development and optimisation for a synthetic peptide drug substance intended for non clinical and clinical use
Oversee scale up and ensure appropriate GMP alignment as the programme transitions into clinical supply
Define and drive formulation strategy and execution for injectable peptide formulations (with exposure to liquid and/or freeze dried (lyophilised) options)
Guide stability strategy (including degradation pathways), excipient/pack compatibility and delivery considerations
Identify, evaluate and select suitable CDMOs (DS, DP and, if needed, analytical/QC partners)
Lead CDMO relationships to ensure delivery to timeline, quality and regulatory expectations
run regular governance and risk management
Drive analytical method development/validation strategy supporting identification, characterisation and quantification in DS/DP
Propose specifications and acceptance criteria for GLP tox / stability batches and GMP clinical batches
ensure documentation is inspection ready

What we offer

expenses (travel to site and CDMOs)

Fulltime

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CMC Regulatory Consultant

CK Group

Location:
Germany , Munich

Category:
Pharmacy

Contract Type:
Employment contract

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
February 20, 2026

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