CMC Regulatory Consultant Job at CK Group (Munich)

Director of Regulatory Affairs, CMC

Hemab is seeking a Director of Regulatory Affairs, CMC to lead global regulatory...

Location

Denmark , København og omegn

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Bachelor's degree in life sciences, chemistry, engineering, or related scientific discipline required
Advanced degree (MS, PhD, PharmD) preferred
8+ years of pharmaceutical/biotechnology industry experience with at least 5 years in regulatory affairs with significant CMC focus, or equivalent combination of technical CMC and regulatory experience
Demonstrated experience with biologics CMC regulatory submissions (INDs, BLAs) and successful health authority interactions
Track record of developing successful CMC regulatory strategies for complex biologics and/or peptides through various stages of development
Experience with preparing global regulatory submissions to FDA and EMA as well as ex-US/EU regulatory Agencies (e.g., PMDA, Health Canada)
Familiarity with submission requirements for Regulatory Agencies in Middle East, Latin America and Asia is highly desirable
Deep understanding of global CMC regulatory requirements and guidance documents for biologics, including ICH guidelines (Q5, Q6, Q8-Q11)
Strong scientific acumen with ability to understand and communicate complex technical CMC information
Demonstrated ability to think strategically while managing tactical execution

Job Responsibility

Lead the development and execution of global CMC regulatory strategies for biologic products, including gene therapies
Serve as the CMC regulatory representative on cross-functional project teams, providing strategic input and guidance
Author and/or review CMC sections of regulatory submissions including INDs, CTAs, BLAs/MAAs, and amendments
Collaborate closely with CMC technical teams (Process Development, Analytical Development, Manufacturing, Quality)
Lead CMC regulatory aspects of health authority interactions, including preparation of briefing documents, responses to agency questions, and participation in regulatory meetings
Proactively identify CMC regulatory risks and develop mitigation strategies
Provide regulatory assessment and strategic guidance for CMC changes throughout the product lifecycle
Oversee CMC regulatory activities conducted by external vendors and consultants
Monitor evolving global CMC regulatory landscape, guidelines, and precedents
Partner with Quality Assurance to ensure CMC activities align with GMP requirements and support regulatory inspections readiness

Fulltime

New

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

New

Senior Principal Scientist, Technical Operations

The Senior Principal Scientist will serve as the technical authority and strateg...

Location

United States

Salary:

175000.00 - 230000.00 USD / Year

Loyal

Expiration Date

Until further notice

Requirements

Ph.D. in Material Science, Chemical Engineering, or related physical science
10+ years of industry experience in preferably small molecule oral solid dosage formulation development, with demonstrated ownership of drug product strategy through clinical stage development
Proven experience leading development of novel molecular entities
Significant experience selecting, managing, and overseeing CDMOs for formulation development, technical transfer, scale-up, and GMP manufacturing
Deep expertise in preferably small molecule oral tablet formulation, process development, compaction fundamentals, and manufacturing science
Demonstrated experience authoring and defending CMC regulatory submissions
Significant hands-on experience designing and executing statistically sound development programs using DoE and data-driven decision frameworks
Experience supporting technical diligence and external partnership evaluations
Demonstrated ability to operate effectively in a dynamic, fast-paced startup environment

Job Responsibility

Own and lead the end-to-end drug product development strategy, including pre-formulation, formulation development, scale-up, and clinical manufacturing
Serve as the technical lead for all drug product activities with CDMOs, including selection, oversight and troubleshooting
Provide strategic guidance on raw material sourcing, manufacturability, product quality risk assessments, and lifecycle management considerations
Identify and proactively mitigate technical, regulatory, and supply risks
develop contingency strategies to ensure program continuity
Author, review, and approve drug product CMC sections for regulatory submissions (IND/CTA and amendments), and represent Drug Product CMC in regulatory agency interactions
Lead technical due diligence efforts, including CDMO evaluation, proposal review, data integrity assessments, and master batch record approval
Establish and implement robust experimental strategies, including design of experiments (DoE), to optimize formulation and process development
Mentor and provide scientific leadership to internal team members and consultants
elevate organizational capabilities in drug product development

What we offer

Full-coverage health insurance — medical, dental and vision — for you and your dependents
$1,000 home office equipment stipend
$1,200/year learning budget for books, courses, etc.
$250/month wellness budget for gym, cleaners, spa, food, etc.
All 3-day weekends are turned into 4-day weekends
Unlimited vacation and paid holidays
Paw-ternity leave — adopt a dog and get a day off with your new family member
Competitive salary
Company equity options grant for new hires

Fulltime

Program Strategy & Operations Director

Join Enveda as a Program Strategy & Operations Director and help us transform na...

Location

United States , Boulder

Salary:

215000.00 - 230000.00 USD / Year

Enveda

Expiration Date

Until further notice

Requirements

Experienced in biotech or pharma program management, portfolio or asset strategy, management consulting, or operations
Demonstrated ability to synthesize information across disciplines and propose clear, data-driven strategic options
Bias for action and ability to move fast and collaboratively to resolve gaps
Excellent communication skills and ability to craft compelling data-driven slides, write crisp summaries, and lead discussions that drive decisions
Leverage AI and digital tools effectively to organize complexity, analyze data, accelerate workflows, and sharpen decision-making
Experience enabling contribution to high-level, long-term strategic decision-making and willingness to execute tactically
Thrive in ambiguity and move fluidly between strategic vision and tactical execution
Display emotional intelligence, humility, and integrity, leading through collaboration
Bring intellectual curiosity, analytical rigor, and a sense of optimism

Job Responsibility

Translate complexity into clarity by distilling scientific, clinical, regulatory, and operational inputs into actionable insights and forward-leaning decisions
Own program execution end-to-end, identifying obstacles and keeping the program moving
Operate as a strategic thought partner to your Asset Entrepreneur, anticipating inflection points and modeling alternative scenarios
Bring rigor and readiness to every forum, from Board updates to investor discussions
Maintain disciplined documentation and operational clarity
Contribute to Enveda’s institutional intelligence
Partner directly with the Asset Entrepreneur to define and evolve the development plan from IND-enabling studies through clinical development
Work shoulder-to-shoulder with functional experts in clinical, translational, regulatory, and CMC
Manage relationships with CROs, consultants, and strategic partners
Contribute to the growing body of operational knowledge

What we offer

90% Medical, Dental, Vision
401k Match
Flexible PTO
Adoption Assistance

Fulltime

Senior Scientist, Drug Formulation and Process Development

At Hemab you will join a clinical-stage biotech company on an exciting journey t...

Location

Sweden , Malmö

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Master’s degree or equivalent in e.g. pharmaceutical sciences, chemical engineering, biotechnology or biology
Minimum 5 years of industrial experience with complex subcutaneous therapeutics
Experience in early and late-stage development has been an integral part in developing and steering products through to market. Preferably with a demonstrated innovative approach
Possess expert knowledge in patient-centric liquid and lyophilized formulations, vial, syringe and combination product development, stability and in-use studies, specifications and justification of specification, process development, GMP fill and finish, technical transfer, and commercial stage manufacturing of complex products
Proven ability to work with outsourcing and managing of CMOs
Experience serving as CMC drug product responsible for multiple programs including drug delivery and combination products is a plus
Experience with regulatory and quality documentation according to cGMP practice
Negotiation, influence, and strong project management and interpersonal communication skills that facilitate collaboration across functions and with consultants and CMOs
A motivated self-starter who is resilient, capable of hitting the ground, running and excelling in a high-growth, entrepreneurial business environment. Proven ability to take initiative in a technical, multicultural global working environment, leading by example while having an inclusive, collaborative style

Job Responsibility

Deliver subcutaneous formulations and drug and combination product manufacturing processes that meet the target product profile
Manage drug product cGMP clinical and commercial manufacturing for various modalities e.g peptides, siRNAs and biologics (antibodies notably), including formulation, process development, technology transfer, quality and life cycle management aspects
Contribute to the selection and management of CMOs for drug product formulation and process development, cGMP manufacture and supply of drug and drug-device combination products
Collaborate with cross-functional R&D partners to develop strategy and execute on activities
Lead, supervise and coordinate the work of CMOs, material suppliers, consultants and vendors as applicable to meet manufacturing development goals
Contribute to ensure that CMOs follow relevant regulatory standards
Support and write regulatory documentation and support interactions with Health Authorities
Other duties as assigned

Fulltime

Senior Scientist, Drug Formulation and Process Development

At Hemab you will join a clinical-stage biotech company on an exciting journey t...

Location

Denmark , København og omegn

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Master’s degree or equivalent in e.g. pharmaceutical sciences, chemical engineering, biotechnology or biology
Minimum 5 years of industrial experience with complex subcutaneous therapeutics
Experience in early and late-stage development has been an integral part in developing and steering products through to market. Preferably with a demonstrated innovative approach
Possess expert knowledge in patient-centric liquid and lyophilized formulations, vial, syringe and combination product development, stability and in-use studies, specifications and justification of specification, process development, GMP fill and finish, technical transfer, and commercial stage manufacturing of complex products
Proven ability to work with outsourcing and managing of CMOs
Experience serving as CMC drug product responsible for multiple programs including drug delivery and combination products is a plus
Experience with regulatory and quality documentation according to cGMP practice
Negotiation, influence, and strong project management and interpersonal communication skills that facilitate collaboration across functions and with consultants and CMOs
A motivated self-starter who is resilient, capable of hitting the ground, running and excelling in a high-growth, entrepreneurial business environment. Proven ability to take initiative in a technical, multicultural global working environment, leading by example while having an inclusive, collaborative style
You work hard and are not afraid to have a little fun while you do so

Job Responsibility

Deliver subcutaneous formulations and drug and combination product manufacturing processes that meet the target product profile
Manage drug product cGMP clinical and commercial manufacturing for various modalities e.g peptides, siRNAs and biologics (antibodies notably), including formulation, process development, technology transfer, quality and life cycle management aspects
Contribute to the selection and management of CMOs for drug product formulation and process development, cGMP manufacture and supply of drug and drug-device combination products
Collaborate with cross-functional R&D partners to develop strategy and execute on activities
Lead, supervise and coordinate the work of CMOs, material suppliers, consultants and vendors as applicable to meet manufacturing development goals
Contribute to ensure that CMOs follow relevant regulatory standards
Support and write regulatory documentation and support interactions with Health Authorities
Other duties as assigned

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

New

GTM Enablement Manager, Client Success

This role acts as the single point of accountability for preparing Customer Succ...

Location

Canada; United Kingdom; Ireland; Spain; Portugal; Italy

Salary:

Not provided

Deel

Expiration Date

Until further notice

Requirements

3+ years of relevant experience in enablement, program management, Customer Success, Sales, or a related role
Strong understanding of Customer Success motions, with at least 2 years of experience working in or closely with CS, Onboarding, or a revenue-impacting role
Experience designing and delivering enablement programs for global, distributed teams
Ability to translate complex product, process, or domain knowledge into clear, actionable learning
Excellent project management and organizational skills
able to balance multiple priorities in a fast-paced environment
Confident facilitator, coach, and communicator with strong presentation skills
fluent in English
Highly collaborative, able to build trust and influence across CS, Product, Enablement, and cross-functional teams
Data-informed and outcomes-focused, with experience defining and tracking enablement KPIs

Job Responsibility

Contribute to the development, delivery, and continuous improvement of Deel’s core global Customer Success enablement programs
Translate business priorities (adoption, retention, expansion, efficiency) into structured, outcome-driven enablement programs for CS roles
Act as a thought partner to CS leadership on capability gaps, readiness needs, and skill development priorities
Design and deliver blended enablement programs, combining live remote sessions, e-learning, self-serve resources, and practical application
Partner with Subject Matter Experts, Product Enablement, and Instructional Design to create high-quality, role-specific learning experiences
Ensure programs are practical, scenario-based, and directly applicable to real client conversations and workflows
Enable CSMs to confidently drive product adoption, value realization, and renewal readiness
Partner with Product and Customer Education to reinforce best practices for ongoing client enablement
Use customer insights, CS feedback, and performance data to identify adoption or retention gaps and design targeted enablement interventions
Define program milestones and success metrics aligned to CS and GTM goals

What we offer

Stock grant opportunities dependent on your role, employment status and location
Additional perks and benefits based on your employment status and country
The flexibility of remote work, including optional WeWork access

Fulltime

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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