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Manager Regulatory Affairs Cmc Jobs

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 Manager Jobs
By Korn Ferry At Boston, MA, United States
5+ years of experience in regulatory affairs environment in nutrition industry.
Excellent knowledge of US and Canada Food Law - Regulations.
Korn Ferry has partnered with our client on their search for the role, Regulatory Affairs Manager.
Ensure compliance of product, ingredients, and claims.
Supply regulatory support for safety files and clinical trials/protocols in order to support R&D.
Vetting and approval of all public materials, including labelling.
Regulatory Affairs Manager Jobs
By Jobot At New York, NY, United States
Strong knowledge of OTC drug and device regulations, including labeling requirements
Significant experience with U.S. drug and/or medical device regulatory submissions and maintenance; OTC preferred
Working knowledge of U.S. clinical research and claims support
Excellent written and verbal communication skills
6+ years of experience in U.S. and/or Canada pharmaceutical or medical device Regulatory Affairs
Drug or medical device submission and/or maintenance experience
Regulatory Affairs Manager Jobs
By Brunel At Dallas-Fort Worth Metroplex, United States
5+ years of progressive regualtory affairs experience
Submissions experience - EU and International markets
Oversee the regualtory function for full product portfolio, managing a team, department and budget
Coordinate regulatory submissions in US and OUS markets
Provide regulatory input/support for audits
Regulatory strategy for product development
Regulatory Affairs Manager Jobs
By DHL At , Westerville, 43082
Presentation and project management skills
Experience with regulatory licensing, regulatory agencies and quality management/systems, practical application a plus
Advisor to Senior Management and Customers on regulatory issues/initiatives, including problem-solving, business pursuits, strategic direction, and significant issues.
Verify and analyze regulatory metrics and create executive management reporting
Coaching support for site management
Experience and working knowledge of Quality Assurance principles and methodology
Regulatory Affairs Program Manager, Us
By ZEISS Group At Dublin, CA, United States

The Regulatory Affairs Program Manager US is responsible for developing and monitoring regulatory submission timelines for a variety of US medical device submissions (such as 510(k)s, IDEs and/or ...

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 Manager Jobs
By Keystone Industries At Gibbstown, NJ, United States
Demonstrated knowledge of current Good Manufacturing Practices (cGMP) and Quality Management Systems (QMS).
Collaborate with QA to ensure the quality management system (QMS) complies with relevant regulations and standards.
Oversees the implementation of risk management processes. Work with cross-functional teams to identify and address potential risks associated with regulated products.
Assesses the impact of regulatory changes on the company's products and processes and ensures compliance with these requirements.
Advise project teams on premarket regulatory requirements.
Advise on export and labeling requirements.
Regulatory Affairs Specialist Cmc
By Viatris At , Remote $41,000 - $93,000 a year
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.
Key responsibilities for this role include:
The minimum qualifications for this role are:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Regulatory Affairs Manager Jobs
By Roche At , Carlsbad, 92008
Analyzes, monitors and provides trending of Recall and Adverse Event Reporting data for Quality Management Review Meeting (QMR).
Other duties as assigned by management.
Experience with Microsoft and Google based applications and general knowledge of PC functions necessary
Experience developing field action processes complaint with global regulatory requirements
Manages the creation and review of Standard Operating Procedures and policy guidelines for the regulatory affairs department.•
5 years of Regulatory Affairs experience. Specific experience with IVD device experience is preferred.
Regulatory Affairs Manager Jobs
By Kelly At Kansas City Metropolitan Area, United States
Prepare regulatory assessments for project teams, line management, and key stakeholders as requested. Includes support for due diligence evaluations.
Degree(s) in a relevant scientific field (BS/MS/Ph.D.) from an accredited institution with appropriate certification in Regulatory Affairs.
High-level knowledge of registration dossier preparation for US FDA/CVM. Including development, drawing conclusions, and the effect of changes.
Proactively monitor, evaluate, and communicate existing and new US regulations impacting products and projects. Assess the potential impact and/or opportunities.
Interface with regulatory authorities on new product development and registration programs, as well as industry associations.
Coordinate technical input for preparation/review of FOI summary and label language for assigned projects.
Regulatory Affairs Manager ( Registered Nurse)
By University of Washington At , Seattle, 98195, Wa $9,000 - $12,840 a month
$ 9,000 - $12,840 per month
Who we are looking for a leader who understands:
This position serves as an expert resource and partner on:
Some of what you will do:
To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 or [email protected].
Cmc Project Manager (Manager/Senior Manager)
By Atalanta Therapeutics At Boston, MA, United States
A minimum of 7-10 years of professional work experience in CMC project management within the Biotechnology or Pharmaceutical field.
Establish and lead cross-functional teams in the operational management of CMC activities to support Atalanta’s pipeline.
Implement CMC project management best practices that optimize pharmaceutical development and analytical services within Atalanta
Ability to work independently and implement Project Management tools, methodologies, and best practices.
Experience with oligonucleotides and/or nucleic acid therapeutics is a plus.
In-depth knowledge of chemical synthesis, process development, analytical development, and quality control concepts
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
Regulatory Affairs Manager Jobs
By DHL At Westerville, OH, United States
Presentation and project management skills
Experience with regulatory licensing, regulatory agencies and quality management/systems, practical application a plus
Advisor to Senior Management and Customers on regulatory issues/initiatives, including problem-solving, business pursuits, strategic direction, and significant issues.
Verify and analyze regulatory metrics and create executive management reporting
Coaching support for site management
Experience and working knowledge of Quality Assurance principles and methodology
Associate Director, Regulatory Affairs Cmc
By GSK At Collegeville, PA, United States
Project management experience with excellent interpersonal, presentation and communication skills.
Three or more years complex worldwide CMC regulatory strategies/requirements and demonstrated ability to influence the global internal/external regulatory environment. 
Two or more years of experience managing and directing multiple projects/teams in a high matrix environment.
One or more years of experience fulfilling a key role in major filing activities.
Experienced in supervising and training junior staff and the ability to motivate and lead others.
Managing the global CMC regulatory activities for multiple projects/teams simultaneously and respond readily to changing events and priorities.
Regulatory Affairs Cmc Specialist (Remote)
By Navitas Life Sciences At Boston, MA, United States
8 to 12 years’ experience working in a regulated, life science environment with Strong project management interpersonal skills.
Experienced in defining Organizational Strategy, Process and Change Management, KPIs and Metrics, Project Management, Resource Forecasting.
Develop and manage day-to-day operations through the use of project management and planning tools, create and maintain detailed project timelines.
Responsible for Product lifecycle management & plan for global regulatory filings and assessments as required by the individual project.
Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements.
Should have demonstrated ability to manage the product life cycle submissions in key regulated markets like US, Canada, UK & EU.
Regulatory Affairs Manager Jobs
By USK Technologies At New York City Metropolitan Area, United States
You will report to the Senior Manager, Quality, Safety and Regulatory Affairs.
Product development experience strongly preferred
Skin and personal care including OTC claim review experience strongly preferred
Track record adhering to compliance requirements (i.e. FDA, Health Canada, EPA, FTC, cGMP, ISO, etc.)
Strong written communication skills, especially detail oriented and technical material
Experience communicating with cross-functional teams and customers including verbal presentations
Manager Of Regulatory Affairs
By Connect Life Sciences At Washington DC-Baltimore Area, United States
Strong management and leadership skills; experience leading/managing a team/project and/or supervising staff preferred.
Works closely with project management to mitigate/resolve issues and/or deviations from target timelines.
Provides regulatory and project management support for projects as needed.
Superior organizational skills and customer service abilities.
Strong working knowledge of Microsoft office; experience with SharePoint a plus.
Supervises and manage Regulatory Team staff members, as assigned.

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