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Regulatory Cmc Jobs in Union, Arkansas

Cmc Junior Data Analyst
By Biotech Partners At United States
Perform data transcriptions, method qualification, method trending, and light analysis on data received from external testing facilities
3+ years of industry experience
Experience in large molecule release such as protein concentrations, SE-HPLC, sterility, and endotoxin
Experience with pre-filled syringe testing
Experience with light analysis on CDMO provided data
Our client is seeking a Remote CMC Junior Data Analyst!
Head Of Cmc Jobs
By Enveda Biosciences At United States
Develop and manage budgets for CMC operations, ensuring cost-effectiveness while maintaining high-quality standards
Forecast and manage the supply of drug product for clinical trials
A minimum of 10-12 years experience in pharmaceutical or biotechnology CMC development with regulatory interactions experience
Excellent cross-functional leadership, team building, and communication skills
Proven experience in tech transfer, manufacturing scale-up, and validation of biotechnology products
Hiring Manager Interview (45 minutes)
Regulatory Affairs Specialist Cmc
By Viatris At United States
Assist departmental management in providing regulatory guidance to other departments (QA, QC, Manufacturing, Technical Services, etc.) for planned changes.
Position functions autonomously and consults with departmental management on an as-needed basis.
Position is remote, but expected to be a normal office situation occurring during typical US business hours.
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
Regulatory Affairs - Chemistry Manufacturing Controls (Cmc)
By Keasis At United States
· Experienced in authoring of assessment reports and Part2/ Expert reports for Dossiers
· Knowledge ofregulatoryguidelines and relevant applications.
· Demonstrate effective leadership, communication, interpersonal skills, and soft skills.
Inviting applications for the role of CMC 3 Manager-RegulatoryAffairs !
Qualifications we seek in you!
• Proven and relevantregulatoryaffairs experience in pharmaceutical, vaccine, or biological products; or related fields
Data Analyst, Cmc Jobs
By EPM Scientific At United States
BS in a quantitative or scientific discipline with 4+ years of relevant data science/analytics experience in the pharmaceutical industry
Experienced with computer languages (R, Python, SQL, etc.) and statistical software packages (JMP, Statistica, Minitab, etc.) to manipulate and analyze data
Experienced with business informatics tools (e.g. Tableau, Power BI, Spotfire)
Prior experience working in a GMP environment and understanding of bioprocessing unit operations is a must
Drive and support data pipeline initiatives
Engage with the delivery of new process analytics tools cross-functionally
Senior Director, Cmc Regulatory Affairs
By Albion Rye Associates At United States
Knowledge or experience with regulatory requirements in other regions and familiarity with GMP regulations is a plus.
In-depth knowledge of ICH requirements and regulatory requirements in the US/EU.
Proficiency in authoring complex technical documents, including CTD M2 and M3 sections, and life cycle management.
8+ years of experience in regulatory CMC within the pharmaceutical or biopharmaceutical industry.
Excellent oral and written communication skills are essential.
Detail-oriented, self-motivated, and comfortable handling broad responsibilities in an entrepreneurial, fast-paced environment.
Associate Director, Cmc Project Manager (Remote) - 23-178
By Elevar Therapeutics At United States
Microsoft Project (or Smartsheet), PowerPoint, Excel skills are essential. SharePoint experience preferred
Create, manage, and facilitate regular meetings, including the development of agendas, issue written minutes, and follow up on action items
5 years of technical CMC small molecule experience in the biotechnology or pharmaceutical industry
Experience in a cGMP environment is required; drug substance and/or drug product manufacturing experience preferred
Excellent verbal and written communication skills. Demonstrated ability to influence peers and stakeholders in business and technical roles
This is a remote-based position located in the United States.
Associate Director/Director Regulatory Cmc
By TG Therapeutics, Inc. At United States
Maintains current knowledge of regulations and guidelines (FDA, ICH, and others as required).
5-10 years experience in regulatory CMC
Coordinate and lead the task of drafting responses to CMC-related questions from FDA or foreign health authorities.
Work with functional groups to provide timely responses to CMC questions from regulatory authorities.
Coordinates activities for meetings with FDA and other regulatory authorities.
Coordinates with cross-functional teams to define contributions to submissions.
Regulatory Affairs Cmc Jobs
By SAGE IT At United States
•Strong leadership qualities including strategic thinking, innovation, people management, project management and excellence in communication
Position - Senior Manager (SM) Regulatory Affairs CMC (Small molecules)
•Manage post approval changes where needed
Qualifications we seek in you!
•Prior experience in big (or mid-size) Pharma companies
•Robust communication and presentation skills
Senior Manager, Regulatory Affairs Cmc
By Agenus At United States
Participates with senior management to establish strategic plans and objectives.
Interacts with senior management, executives, and/or major customers which frequently involves negotiating matters of significance to the organization.
Directs the activities of a functional area or multiple integrated departments through lower management.
Ensures budgets and schedules meet corporate requirements.
Agenus is Delighted to Provide you With a Comprehensive Benefits Plan, Including Some of the Following:
Makes final decisions on implementation and ensures operational effectiveness.
Cmc Senior Project Manager
By SSi People At United States
Microsoft Project (or equivalent project management software) and Microsoft Office skills
At least 2-years of experience as a project manager
10-years of experience in the Pharmaceutical, Biotechnology or Biomedical related field, direct CMC experience is highly desirable
Facilitation and soft skills to work with cross functional teams
Critical thinking and problem-solving skills
Develop and use project plans and schedules to measure and report progress.
Cmc Project Manager Jobs
By SSi People At United States
Ensure teams active, aligned communication in functional and cross-functional management reviews and governance meetings
Job Title: CMC Project Manager - Remote
Establish and manage collaboration and team sites. Track delivery and create repositories for all PD deliverables
Assist PD in driving decision making and communication
Pay Rate: $70/hr to $75/hr
Remote In Ma: Regulatory Cmc Consultant (233298)
By Black Diamond Networks At United States

Job Description: Our biotech client needs a Regulatory CMC Consultant. Job is Part-time. Some CAR-T experience is wanted for this. Some other projects are gene therapy which are on the backburner ...

Cmc Regulatory Technical Writer - Remote
By Synectics Inc. At United States
Excellent oral and written communication skills for effectively interfacing with higher levels of management and departments within the company
Support BLA/MAA/ROW (emerging markets) expansion effort for a biologics project, including compilation of market-specific requirements and leading information request response preparation.
Ad hoc RA CMC support to line manager.
Good writing skills for technical writing
***Compensation is based on experience***
Track submission activities and change controls for RACMC and ensure visibility to cross-functional CMC stakeholders.
Director, Regulatory Affairs Cmc
By Agenus At United States
Participates with senior management to establish strategic plans and objectives.
Interacts with senior management, executives, and/or major customers which frequently involves negotiating matters of significance to the organization.
Directs the activities of a functional area or multiple integrated departments through lower management.
Ensures budgets and schedules meet corporate requirements.
Agenus is Delighted to Provide you With a Comprehensive Benefits Plan, Including Some of the Following:
Makes final decisions on implementation and ensures operational effectiveness.
Sr Director Regulatory Affairs Cmc
By Discover International At United States
Extensive knowledge of global regulatory requirements and guidelines for CMC in drug development.
Provide strategic guidance on CMC requirements for drug development programs.
Strong leadership skills, with a track record of managing high-performing teams.
Excellent communication and interpersonal skills for effective collaboration.
Strong problem-solving and strategic thinking abilities.
Develop and implement global regulatory CMC strategies aligned with corporate objectives.
Regulatory Cmc Jobs
By Discover International At United States
Strong project management skills, with the ability to manage multiple projects simultaneously.
Develop and implement CMC regulatory strategies for new product development and product lifecycle management.
Knowledge of regulatory requirements and guidelines, including FDA and EMA regulations
Manage and oversee the preparation and submission of regulatory documents, including INDs, BLAs, and amendments.
Provide guidance and support to cross-functional teams on regulatory CMC requirements and strategies.
Stay up to date with changes in regulatory requirements and industry trends that may impact product development and regulatory submissions.
Sr. Director Of Cmc
By EPM Scientific At Greater Boston, United States
Past Management Experience is a MUST
Will work and manage in-house and outsourced lab activities
Experience working amongst CMC leaders such as Regulatory, Analytical, and Quality
Experience overseeing outsourced vendors (CMOs/CDMOs)
Experience overlooking multiple drug candidates within the company's pipelines
M.S. or Ph.D. in Pharmaceutical Sciences or a related scientific field with ideally 10-15 years of industry experience
Associate Director Of Drug Product Cmc
By EPM Scientific At Greater Boston, United States
• Interpret raw data, organize results, generate/review reports, and communicate findings to project teams and management
• Extensive experience from Discovery, Pre-formulation, Formulation to Commercialization
• Experienced in formulation design, scale-up, tech transfers, & Quality by Design (QbD) studies.
• Past experience overseeing outsourced vendors (CROs/CMOs/CTLs/CDMOs) – highly coveted
• Experience authoring CMC sections for IND, BLA & MAA is highly sought after
Associate Director/Director - Formulations(Drug Product)
Cmc Lvn Jobs
By CUERO REGIONAL HOSPITAL At , Cuero, 77954 $24.34 an hour
Clinical experience and great customer service skills.
Medical knowledge in pediatric patients and vaccines.
The LVN is responsible for the direct and indirect care of the clinic patients.
The LVN assists the physician and/or mid-level provider providing care to patients.