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

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 Billing & Coding Compliance Consultant

Our client is seeking a Senior Billing & Coding Compliance Consultant to serve a...

Location

United States , Dallas

Salary:

Not provided

Medasource

Expiration Date

Until further notice

Requirements

High School Diploma or equivalent and six (6) years of experience in a professional billing environment with emphasis on coding, auditing, and/or compliance responsibilities
Certification as Certified Professional Coder (CPC), Certified Coding Specialist (CCS), or Certified Medical Coder (CMC) required
Must obtain Certified Professional Medical Auditor (CPMA) certification within 12 months of hire
Strong knowledge of CPT, HCPCS, and ICD-9-CM coding systems, medical record documentation standards, and accepted billing/coding standards
Ability to analyze medical records, billing history, payer rules, and other data to validate regulatory compliance and organizational billing integrity
Experience developing and conducting coding and compliance training and presentations for individuals and groups
Strong verbal and written communication skills
Ability to work independently and collaboratively as a team member
Proficiency in Microsoft Office (Word, Excel, PowerPoint)
Detail-oriented with strong organizational and prioritization skills

Job Responsibility

Serve as a billing integrity project leader for all service lines, developing and conducting individual or group presentations on coding, billing, and compliance topics
Develop and deliver standardized and specialty-driven coding and compliance training (“onboarding”) for new providers
Perform post-onboarding pre-bill reviews of professional charges for any service line
Assist in ensuring pending charges are reviewed and released in a timely manner
Independently review the adequacy of medical record documentation to support procedure, modifier, and diagnosis coding, identify compliance risks, and develop recommended solutions or action plans
Summarize findings and develop action plans for risk mitigation
Research and respond to coding, documentation, and reimbursement policy questions or problems
Support and/or conduct risk-based billing compliance audits and provide resulting education in coordination with the Compliance Office
Complete charge review and follow-up Epic work queue assignments for any service line
Provide training to new internal or contractor staff on audit software, Epic, audit plans, and work queue assignments

What we offer

Competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage
401k plan with company match
Paid time off, sick time, and paid company holidays
Employee Assistance Program (EAP) providing services like virtual counseling, financial services, legal services, life coaching

Software Engineer

Meta Platforms, Inc. (Meta), formerly known as Facebook Inc., builds technologie...

Location

United States , Sunnyvale

Salary:

190853.00 - 209000.00 USD / Year

Pharmacy Technician

We’re building a world of health around every individual — shaping a more connec...

Location

United States , Beckley

Salary:

16.00 - 24.00 USD / Hour

CVS Health

Expiration Date

May 30, 2026

Requirements

Must comply with any state board of pharmacy requirements or laws governing the practice of pharmacy, which includes but is not limited to, age, education, and licensure/certification
If the state board of pharmacy does not address or mandate a minimum age requirement, must be at least 16 years of age
If the state board of pharmacy does not address or mandate a minimum educational requirement, must have a high school diploma or equivalent, or be actively enrolled in high school or high school equivalency program
Regular and predictable attendance, including nights and weekends
Ability to complete required training within designated timeframe
Attention and Focus: Ability to concentrate on a task over a period of time
Ability to pivot quickly from one task to another to meet patient and business needs
Ability to confirm prescription information and label accuracy, ensuring patient safety
Customer Service and Team Orientation: Actively look for ways to help people, and do so in a friendly manner
Notice and understand patients’ reactions, and respond appropriately

Job Responsibility

Support the pharmacy team in delivering operational and service excellence within your store
Assist the pharmacy team to ensure that pharmacy operations run smoothly, our patients’ prescriptions are filled promptly, safely, and accurately, and we are providing caring service that exceeds patient expectations
Operate as part of the pharmacy team through consistent application of Standard Operating Procedures (SOPs), best practices, and effective communication
Living our purpose by following all company SOPs at each workstation to help our Pharmacists manage and improve patient health
Following pharmacy workflow procedures at each pharmacy workstation (i.e., production, pick-up, drive-thru, and drop-off) for safe and accurate prescription fulfillment
Contributing to positive patient experiences by showing empathy and genuine care: creating heartfelt and personalized moments while serving patients at pick-up, drive-thru, and over the phone
keeping patients healthy by offering immunizations and other services at the register and over the phone
and demonstrating compassionate care by solving or escalating patient problems
Completing basic inventory activities, as permitted by law, and as directed by the pharmacy leadership team, such as accurately putting away medication deliveries and completing cycle counts, returns-to-stocks, waiting bin inventories, etc.
Contributing to a high-performing team, embracing a growth mindset, and being receptive to feedback

What we offer

Affordable medical plan options
a 401(k) plan (including matching company contributions)
an employee stock purchase plan
No-cost programs for all colleagues including wellness screenings, tobacco cessation and weight management programs, confidential counseling and financial coaching
Benefit solutions that address the different needs and preferences of our colleagues including paid time off, flexible work schedules, family leave, dependent care resources, colleague assistance programs, tuition assistance, retiree medical access and many other benefits depending on eligibility

Parttime

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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