CMC Project Management Specialist Job at Enveda

CMC Project Management Specialist

Join Enveda as a CMC Project Management Specialist in a remote capacity and help...

Location

United States

Salary:

95000.00 - 115000.00 USD / Year

Enveda

Expiration Date

Until further notice

Requirements

B.S./M.S./Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or similar degree
1-2+ years of CMC project management experience in biotech or pharma, with exposure to drug substance and drug product development
Ability to manage cross-functional projects and communicate technical details clearly
Experience working with external CROs and CDMOs

Job Responsibility

Lead cross-functional planning and execution of CMC development activities across drug substance and drug product
Partner with internal and external teams to define and track development strategies, timelines, and deliverables
Oversee and monitor external CRO and CDMO activities, including planning, communication, and batch execution timelines
Develop and manage detailed CMC project plans, ensuring timely delivery through proactive communication and follow-up

What we offer

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

Fulltime

New

Senior Regulatory Affairs Product Specialist

The Senior Regulatory Affairs Product Specialist serves as a key regulatory part...

Location

Poland , Warsaw

Salary:

Not provided

Theramex

Expiration Date

Until further notice

Requirements

Advanced experience with practical European Regulatory Affairs, including a good understanding of the following MA lifecycle activities within DCP, MRP and National procedures (preferably also other than URPL): post-authorisation variations impacting CMC, Safety and Product Information
different submission strategies (e.g. single, grouping, SuperGrouping, WorkSharing)
other RA activities such as renewals and PSURs/PSUSAs
CTD/eCTD documentation structure and lifecycle management
Knowledge and understanding of the following areas, European regulations and related guidance documents (e.g. management of documents, submissions, requirements): regulatory submissions across different markets and procedures, including the Centralised Procedure
Product Information authoring, editing and management
CMC documentation requirements
CTD and eCTD authoring, editing and lifecycle management
Able to perform other Regulatory Affairs activities with team support (e.g. PASS, PAMs, Centralised Procedure submissions)
Able to perform accompanying activities such as Artwork reviews/approvals and Prescribing Information preparation

Job Responsibility

Preparation and submission of required regulatory packages for designated products/countries, including variations and lifecycle activities
Authoring/updating of key regulatory documentation including CTD components and Product Information and leading review of other technical documents to ensure regulatory compliance
Development and implementation of regulatory strategy for required changes
Act as the contact within the business for regulatory advice and support related to designated products
Provide support and regulatory advice to key internal stakeholders including MS&T, Quality, Pharmacovigilance, Supply and other teams
Identification of any gaps in the regulatory documentation and conduction of any remediation necessary to achieve compliance
Communication with external stakeholders, including regulatory agencies, CMO's and third party service providers
Creation and maintenance of Regulatory Information Management systems and databases records and entries
Support of creation and maintenance of SOPs, working instructions describing regulatory and labelling processes and best practices to ensure compliance

What we offer

A fast-paced environment with broad exposure, giving you opportunities to develop professionally - even outside your core area of expertise
A culture that supports learning, celebrates success, and recognizes performance
Opportunities for driven and talented professionals to contribute to our exciting journey

Fulltime

Senior Product Specialist, Regulatory Affairs

The Senior Regulatory Affairs Product Specialist serves as a key regulatory part...

Location

United Kingdom , London

Salary:

Not provided

Theramex

Expiration Date

Until further notice

Requirements

Extensive experience with practical European Regulatory Affairs
Good understanding of MA lifecycle activities within DCP, MRP and National procedures (Post-authorisation variations, submission strategies, renewals, PSURs/PSUSAs)
Knowledge of CTD/eCTD documentation structure and lifecycle management
Knowledge of European regulations and related guidance documents for Regulatory submissions, Product Information authoring, CMC documentation, CTD and eCTD authoring
Able to perform other Regulatory Affairs activities with team support (e.g., PASS, PAMs, Centralised Procedure submissions)
Able to perform accompanying activities such as artwork reviews/approvals and Prescribing Information preparation
Good interpersonal skills and effective problem-solving capabilities
Proactive, adaptable and comfortable working across multiple projects while maintaining high standards
High attention to detail with excellent organisational and time-management skills
Excellent written and verbal communication skills in English

Job Responsibility

Preparation and submission of required regulatory packages for designated products/countries
Authoring/updating of key regulatory documentation including CTD components and Product Information
Development and implementation of regulatory strategy for required changes
Act as the contact within the business for regulatory advice and support related to designated products
Provide support and regulatory advice to key internal stakeholders
Identification of any gaps in the regulatory documentation and conduction of any remediation necessary to achieve compliance
Communication with external stakeholders, including regulatory agencies, CMO’s and third party service providers
Creation and maintenance of Regulatory Information Management systems and databases records and entries
Support of creation and maintenance of SOPs, working instructions describing regulatory and labelling processes and best practices to ensure compliance

What we offer

25 days holiday + 8 bank holidays
Private Health Insurance for employee and family members
Pension contribution: 10% company + 5% employee (auto-enrolled from day one)
Hybrid Working
Cycle to Work Scheme
Engaging employee experience to come together as a community: in-office events, shared learning and much more

Fulltime

Drug Substance Senior Specialist – Biologics

We are seeking a Drug Substance Senior Specialist with strong experience in biol...

Location

Denmark , København og omegn

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Master’s degree in biotechnology, chemical engineering, pharmaceutical sciences, or related field
8+ years of industry experience in biologics process development and validation, including collaboration with CDMOs
Proven experience with PPQ and process characterization for antibody drug substances
Solid understanding of ICH Q8–Q11 and global validation expectations
Practical knowledge of commercial-scale GMP operations, tech transfer, and regulatory submissions
Experience in early-stage process development and scale-up
Strong project management and organizational abilities
Excellent communication and technical writing skills for regulatory documentation
Collaborative mindset and ability to work effectively with external partners
Flexible, proactive, and comfortable operating in a fast-paced biotech environment

Job Responsibility

Support early-stage antibody programs by applying phase-appropriate development strategies
Collaborate with Quality, Regulatory, and Analytical teams to align on validation approaches
Provide technical input to CDMOs on process design, scale-up, and risk assessments
Plan and manage process performance qualification (PPQ) and characterization studies in partnership with CDMOs
Define and document CPPs, CQAs, and control strategies based on risk and data-driven insights
Ensure validation documentation (protocols, reports, summaries) complies with ICH Q8–Q11, FDA, and EMA expectations
Support implementation of continuous process verification (CPV) and lifecycle validation strategies
Oversee technology transfer to external manufacturing partners for commercial readiness
Contribute to CMC regulatory submissions (BLA/MAA) focusing on validation and control strategy
Coordinate comparability studies and process optimization activities with CDMOs

Fulltime

Specialist I/II, Regulatory Affairs

The Regulatory Specialist will participate in the preparation of documentation p...

Location

United States , Cambridge

Salary:

130000.00 - 160000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Minimum BA/BS degree in a scientific/engineering discipline
6+ years’ experience in the biotech industry
8-10+ years’ experience in Regulatory CMC, or related experience (e.g., manufacturing, analytical, quality assurance) as a strong dossier preparation contributor for IND/CTA/MF and BLA/MAA submissions
Comprehensive knowledge of regulatory (FDA. EMA, and ICH) guidelines
with a demonstrated ability to articulate and apply these principles to regulatory CMC strategies for novel products
Strong experience with CTD format and content regulatory filings
Excellent organizational, written/oral communication, and time management skills
ability to communicate complex issues in a succinct and logical manner
strong listening skills
Experience with related CMC disciplines (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving

Job Responsibility

Able to prepare documentation packages for global regulatory submissions (including IND, CTA, Briefing Books, Scientific Advice, etc.) to the FDA and global regulatory agencies
Compiles documentation for submissions to FDA and global regulatory agencies
Support the development of regulatory strategies, risks and key issues in an evolving regulatory landscape
Support the develop regulatory processes and procedures of regulatory submissions
Develops and maintains collaborative partnerships with key internal and external stakeholders
Participate in regulatory intelligence activities, monitor regulatory guidelines and trends as they pertain to global regulations and guidance, and provide regulatory advice to project teams regarding the applicability/impact on internal programs
anticipate and communicate possible regulatory paradigm shifts

Fulltime

New

Senior Eng, Test

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

India , Bengaluru

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelors / Masters in Computer Science, Computer Engineering, Electrical Engineering, Software Engineering or related field and 7+years of related experience
A demonstrated track record in regulated software development, preferably medical devices or other highly regulated products such as aviation software
Experience working in medium to large VnV teams
Experience in executing verification strategies including and not limited to functional, non-functional, reliability, performance
Experience in defining or re-defining test architecture and test automation frameworks
Working knowledge of enterprise software architecture nuances
Excellent knowledge of enterprise software automation tools
Knowledge of medical device software development & verification is highly preferred including knowledge of standards such as IEC 62304, ISO 14971
Experience working in an Agile/Scrum development process
Understands nuances of small to medium scaled enterprise software

Job Responsibility

Clearly understand the scope and execute test strategy independently
Clearly document the test cases, test data management
Design the test workflows, protocols and test data and clearly documents test case in test suites
Plan and execute system integration activities to minimize issues in systems verification
Assist in the documentation of traceability from requirements to verification activities, and from requirements to design entities
Develop and maintain an effective and corroborative working relationship with internal and external development partners
Provide leadership to effectively define, communicate and execute test strategy to ensure product quality and delivery are maintained
Lead and collaborate with verification team to drive improvements to test execution, quality and delivery
Well versed with various test design techniques like Pair Wise Testing, Orthogonal Array Testing to design test protocols with optimized test coverage
Well versed with test metrics to define efficiency, effectiveness, quality and performanceof software testing technique

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

New

Speech Language Pathologist

As our Speech Language Pathologist, you will help evaluate and treat patients wi...

Location

United States , Tacoma

Salary:

45.26 - 67.32 USD / Hour

American Nursing Care

Expiration Date

Until further notice

Requirements

Masters in Speech-Language Pathology required
Three months of recent experience (three-month internship may apply) in the field of Speech-Language Pathology in a hospital or rehabilitation setting with an emphasis in adult neurological services that demonstrates attainment of the requisite job knowledge skills/abilities.

Job Responsibility

Perform patient assessment/data collection and formulates treatment plans for individuals with disorders of cognition, communication and swallow
Reviews goals and treatment plan with patient and/or caregiver
Review medical record/documentation prior to initial evaluation to familiarize self with patient’s history and obtains necessary information to perform a thorough, quality assessment
Develop Speech Language Pathology plan of care to meet established goals and individualized needs of patient/client
Select and administers assessment tools according to standards as established by profession and department
Complete functional swallow/communication assessment related to patient’s individual needs within the designated service area
Demonstrate clinical skills for differentially diagnosing communication and cognitive skills
Demonstrate clinical skills for differentially evaluating and diagnosing swallowing and obtains baseline swallow status, assesses risks for aspiration, determines diet level
Perform video swallow studies and FEES to evaluate, diagnose and treat swallowing issues
Communicate status, needs and treatment plan with the patient and designated caregiver(s)/staff in an effective manner

What we offer

Medical
Prescription drug
Dental
Vision plans
Life insurance
Paid time off (full-time benefit eligible team members may receive a minimum of 14 paid time off days, including holidays annually)
Tuition reimbursement
Retirement plan benefit(s) including, but not limited to, 401(k), 403(b), and other defined benefits offerings
$10,000.00 Sign On Bonus if offered 6.20.26

Fulltime

New

Associate Marketing Manager

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

India , Bengaluru

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree in marketing, business, or science/technology field required
MBA is a plus
8-12 years of professional experience, including at least 1 year in MedTech, pharma, or healthcare
Experience with global or regional markets preferred
Strong capability in market sizing, forecasting, and scenario modeling
Proficiency with Excel, Power BI, Tableau, and analytics tools
Proven success managing complex cross-functional initiatives
Strong stakeholder influence and leadership skills in matrixed environments

Job Responsibility

Lead marketing analytics and new market expansions for the Infusion Therapies & Technologies (ITT) division
Serve as the upstream marketing lead for our pharmacy tools portfolio
Partner with global commercial teams, finance, R&D, project management, and manufacturing strategy to execute assigned projects
Approximately 80% of the role is focused on market expansion strategy, analytics, and cross-functional workstream management
20% dedicated to upstream marketing leadership for the pharmacy tools portfolio

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

CMC Project Management Specialist

Enveda

Location:
United States

Category:
Research and Development

Contract Type:
Not provided

Salary:

Requirements:

Additional Information:

Job Posted:
February 17, 2026

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Job Posted:February 17, 2026

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