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Manager Regulatory Affairs Cmc Jobs in Union, Arkansas

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.
Manager/Senior Manager Regulatory Affairs
By RBW Consulting At United States
Knowledge/experience with regulatory requirements for other regions is desirable.
Independently plan and manage regulatory activities related to assigned projects, covering areas such as clinical, non-clinical, and CMC, with minimal supervision.
Manage the preparation, review, and timely submission of regulatory dossiers required for investigation and registration of products in relevant markets.
BA/BS degree or equivalent experience in a pharmaceutical or health science field is required.
Minimum of 7 years of related experience in regulatory affairs is required.
Familiarity with CTD/eCTD and experience in publishing documents using Adobe Acrobat Professional.
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
Regulatory Affairs Manager Jobs
By Mackenzie Stuart At United States
Bachelor's degree in scientific discipline or equivalent experience
5+ years' working experience in pesticide regulatory experience
Experience with registrations with US EPA and/or other regulatory authorities
Knowledge of EPA regulatory process – specifically, FIFRA 40 CFR part 158
Regulatory Manager for crop protection products (North America)
Overseeing regulatory activities and submissions for crop protection chemicals
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.
Senior Manager Regulatory Affairs
By Athletic Greens At United States
Minimum of 8+ years of demonstrated Regulatory Affairs experience and in-depth knowledge of regulatory requirements in the Dietary Supplement industry.
Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
Bachelor's Degree in Science, Nutrition or related field preferred, or a combination of education and equivalent work experience.
Review and approve new and/or revised labels and ensure labeling content and product documentation is developed in accordance with regulatory requirements.
Review formula, raw material and finished product specifications to ensure compliance with regulatory requirements.
Prepare and process documentation required for product registrations, notifications and certifications in applicable international markets
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.
Regulatory Affairs Manager - Consumer Medical Devices
By Mira At United States
Ensure all regulatory requirements are met throughout the product development lifecycle
Review advertising and marketing materials, ensure appropriateness and compliance to FDA regulatory requirements
Maintaining current knowledge of FDA and international regulation and standards, as applicable to company products
Experience in 510k submission and MDR cases is required
Should have experience in working with startups
Strong analytical and strategic skills are required

Are you looking for an exciting opportunity to join a dynamic team and make a real impact in the field of Regulatory Affairs CMC? We are looking for a Manager Regulatory Affairs CMC to join our team and help us shape the future of our company. You will be responsible for developing and implementing regulatory strategies for CMC activities, ensuring compliance with applicable regulations, and providing regulatory guidance to internal and external stakeholders. If you have a passion for regulatory affairs and a drive to make a difference, this is the job for you!

Overview:

The Manager Regulatory Affairs CMC is responsible for providing regulatory guidance and support to the organization in the development and maintenance of CMC (Chemistry, Manufacturing, and Controls) regulatory strategies. This role will ensure that the organization is compliant with all applicable regulations and guidelines, and will provide guidance on CMC regulatory activities.

Detailed Job Description:

The Manager Regulatory Affairs CMC will be responsible for developing, implementing, and maintaining CMC regulatory strategies for the organization. This role will provide regulatory guidance and support to the organization in the development and maintenance of CMC regulatory strategies. The Manager Regulatory Affairs CMC will be responsible for ensuring that the organization is compliant with all applicable regulations and guidelines, and will provide guidance on CMC regulatory activities. This role will also be responsible for preparing and submitting regulatory documents to the relevant regulatory authorities, and for monitoring and responding to regulatory changes.

What is Manager Regulatory Affairs Cmc Job Skills Required?

• Knowledge of CMC regulatory requirements and guidelines
• Excellent written and verbal communication skills
• Ability to work independently and as part of a team
• Ability to manage multiple projects simultaneously
• Strong organizational and problem-solving skills
• Ability to work in a fast-paced environment

What is Manager Regulatory Affairs Cmc Job Qualifications?

• Bachelor’s degree in a related field
• 5+ years of experience in a regulatory affairs role
• Knowledge of CMC regulatory requirements and guidelines
• Experience in preparing and submitting regulatory documents
• Knowledge of FDA and other regulatory requirements

What is Manager Regulatory Affairs Cmc Job Knowledge?

• Knowledge of CMC regulatory requirements and guidelines
• Knowledge of FDA and other regulatory requirements
• Knowledge of pharmaceutical development processes
• Knowledge of Good Manufacturing Practices (GMP)

What is Manager Regulatory Affairs Cmc Job Experience?

• 5+ years of experience in a regulatory affairs role
• Experience in preparing and submitting regulatory documents
• Experience in developing and maintaining CMC regulatory strategies
• Experience in monitoring and responding to regulatory changes

What is Manager Regulatory Affairs Cmc Job Responsibilities?

• Develop, implement, and maintain CMC regulatory strategies for the organization
• Provide regulatory guidance and support to the organization in the development and maintenance of CMC regulatory strategies
• Ensure that the organization is compliant with all applicable regulations and guidelines
• Prepare and submit regulatory documents to the relevant regulatory authorities
• Monitor and respond to regulatory changes