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

Supervising Social Worker

As a Supervising Social Worker, you will: Support and supervise foster carers to...

Location

United Kingdom , Swansea

Salary:

36.00 - 38.43 GBP / Hour

Randstad

Expiration Date

Until further notice

Requirements

Qualified Social Worker with a Social Work Degree or equivalent qualification
Registered with Social Care Wales
A minimum of 2 years' post-qualifying experience working with children and families in the UK
Experience in fostering or children's services, with the ability to work independently and start promptly
A current and valid DBS check

Job Responsibility

Support and supervise foster carers to ensure the highest standards of care for children and young people
Undertake assessments, reviews, and reports in line with fostering regulations and statutory guidance
Contribute to the ongoing development and delivery of the fostering service
Work collaboratively with colleagues across the Council and partner agencies
Manage a caseload effectively, combining office-based and remote work

What we offer

training and education
A full range of free training e-learning courses are available

Fulltime

New

Assistant Manager

We want you to join our team as an Assistant Manager. If you have the desire to ...

Location

United States of America , Aberdeen

Salary:

Not provided

Circle K

Expiration Date

Until further notice

Requirements

Ability to stand and/or walk for up to 8 hours
Lift and/or carry up to 30 pounds from ground to overhead up to 30 minutes in a shift
Occasionally lift and/or carry up to 60 pounds from ground to waist level
Push/pull with arms up to a force of 20 pounds
Bend at the waist with some twisting up to one hour a shift
Grasp, reach and manipulate objects with hands

Job Responsibility

Assist the Store Manager with oversight of the Stationstore operations
Hiring, supervising and working with the staff to accomplish daily tasks, bookkeeping and merchandising
Maintain high standards and provide fast and friendly service to customers
Provide regular and predicable onsite attendance

What we offer

Medical, Vision, Dental, & Life Insurance/Short & Long Term Disability
Flexible Schedules
Weekly Pay
Paid Vacations
Large, Stable Employer
Fast Career Opportunities
Work With Fun, Motivated People
Task Variety
Paid Comprehensive Training
401K With a Competitive Company Match

New

Senior Tax Associate

We are looking for an experienced Senior Tax Associate to join a small independe...

Location

United States , West Palm Beach

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

At least 5 years of public accounting experience with hands-on exposure to tax preparation and client service
Bachelor’s degree in Accounting or a closely related field
Active CPA license is required
Demonstrated experience preparing individual and business tax returns, along with strong overall tax compliance knowledge
Proficiency with QuickBooks and Microsoft Office applications, including Word and Excel
Familiarity with tax software such as CCH ProSystem fx, CCH ProSystem, UltraTax, or similar platforms
Strong analytical ability, sound judgment, and careful attention to detail
Effective written and verbal communication skills, with the ability to manage multiple priorities in a fast-paced setting

Job Responsibility

Prepare and review tax filings for individuals, corporations, partnerships, and trusts, including required foreign account reporting forms
Advise self-employed clients and business owners on practical tax planning strategies that support informed financial decisions
Complete quarterly and annual payroll tax filings accurately and within established deadlines
Oversee the timely preparation of recurring sales tax submissions on a monthly and quarterly basis
Record adjusting journal entries and assist with the assembly of year-end financial statements for client accounts
Support clients with QuickBooks-related needs, including account cleanup and improvement of financial report accuracy
Serve as a point of contact with federal and state tax authorities to address notices, inquiries, and compliance matters
Collaborate with clients and internal stakeholders to maintain organized records and ensure high-quality deliverables across engagements

What we offer

Medical, vision, dental, and life and disability insurance
company 401(k) plan

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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