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

Senior Regulatory Affairs Specialist

Location

United States , St. Louis

Salary:

44.00 - 47.00 USD / Hour

Beacon Hill

Expiration Date

Until further notice

Requirements

Bachelor Degree in scientific discipline required or equivalent work experience
5 or more years of Regulatory experience or related field. RAC certification preferred
Cross functional interaction experience, coordinating activities, driving projects and initiatives to completion, and working to align communications with other departments is required
Project leadership or supervisory experience is preferred
Strong organizational skills, strong attention to detail, ability to problem solve and to work well with others and cross-functionally
Excellent written and oral communication skills
Use of software system to manage change controls
Strong background using Microsoft Office tools and Adobe Acrobat
Travel Time Required – up to 10%

Job Responsibility

Support of US FDA applications (NDAs, ANDAs, DMFs)
Plan/author/compile/submit statutory reports in eCTD format for marketed products per FDA requirements
Review, assess CMC regulatory impact and provide regulatory strategy for post-approval changes proposed at the manufacturing site
Act as the CMC regulatory lead to cross-functional teams on health authority requirements and preparation of information/technical data needed for support of post-approval changes
Author/compile/submit post-approval change supplements
Author/review updates to marketed product labeling
Maintain regulatory knowledge of current guidelines and regulations
Maintain current regulatory databases and produce various reports as needed
Utilize and support electronic document management system
Provides mentorship for entry-level and intermediate-level regulatory associates

Senior Regulatory Specialist

At GSK, we unite science, technology, and talent to get ahead of disease togethe...

Location

India , Bengaluru

Salary:

144750.00 - 241250.00 PLN / Year

GSK

Expiration Date

Until further notice

Requirements

Bachelor's degree in Chemistry, pharmacy or other related biological science or technical bachelor's degree
English language skills
Knowledge of drug development and manufacturing and supply processes
Knowledge of worldwide CMC post-approval regulatory requirements
Can identify areas for personal professional growth in global regulatory affairs with appropriate support from line manager
Service orientation, customer-focused

Job Responsibility

Responsible for the timely delivery of regulatory activities of multiple projects across dosage forms
Represents New Registration CMC, on Regulatory Networks and Matrix Teams providing guidance to Global Supply Chain (GSC), Commercial, Quality Assurance, 3rd Party Contract Management (via ESQ) and Office of the Chief Medical Officer (OCMO) to produce appropriate components for global regulatory dossiers
Will serve as a mentor/trainer for new team members
May act as a Subject Matter Expert for specific areas for consultation within the team/ department as well as externally outside the department
Independently and confidently executes agreed dossier strategy
Independently manages multiple project simultaneously
assignments will range in complexity but more complex work is expected
Independently completes data assessment to ensure dossier is fit for purpose
Identifies risks associated with submission data and information packages
Escalates issues with line manager that have business impact

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes
Annual bonus
Eligibility to participate in our share based long term incentive program

Fulltime

Lead Medical Writer

Our client is a global healthcare services and products company providing pharma...

Location

United States , Dublin

Salary:

80.00 - 95.00 USD / Hour

Medasource

Expiration Date

Until further notice

Requirements

Advanced degree in life sciences (PhD, PharmD, MD, or MS preferred)
5+ years of regulatory/medical writing experience in the pharmaceutical industry across several therapeutic areas
Proven ability to autonomously write and review clinical regulatory documents (e.g., CTD Module II summaries, CSRs, Clinical Overviews, Investigator brochures, and other regulatory submissions)
Strong knowledge of regulatory document requirements and guidelines
Experience contributing scientifically and strategically to submission teams
Ability to plan data analyses and review statistical analysis plans for CSRs
Excellent collaboration skills with cross-functional stakeholders
Well-developed medical writing skills with attention to quality and deadlines
Ability to mentor and develop junior medical writers
Ability to work independently and as part of a team

Job Responsibility

Autonomously write and review clinical regulatory documents, including CTD Module II summaries, Clinical Overviews, Clinical Study Reports (CSRs), and other regulatory submissions such as responses to health authority questions, briefing books, 120-day safety updates, pediatric investigational plans, and investigator brochures
Contribute scientifically and strategically to submission teams at the project and/or study team level, providing input on pooling strategy, content expertise, and guidance on regulatory requirements
Plan and review data analyses and presentations for CSRs
review statistical analysis plans and related documents
Collaborate effectively with cross-functional stakeholders, including Clinical Sciences, Clinical Pharmacology, Biometry, Drug Safety, Clinical Operations, CMC, and Regulatory Affairs
Work with in-house Documentation Specialists to produce high-quality final documents and ensure timely delivery
Mentor and develop junior medical writers, providing guidance and support as needed
Demonstrate advanced medical writing skills and maintain up-to-date knowledge of regulatory document requirements and guidelines
Work independently and as part of a team, managing multiple priorities and meeting challenging deadlines
Exhibit excellent interpersonal and presentation skills in all interactions

What we offer

Medical coverage
Dental coverage
Vision coverage
Health Savings Account
Dependent Care FSA
Supplemental coverage
401k plan with company match
Paid time off
Sick time
Paid company holidays

Fulltime

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

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

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

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CMC Project Management Specialist

Requirements

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CMC Project Management Specialist

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