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Manager Regulatory Affairs Cmc Jobs

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.
Regulatory Affairs Sr/Mgr (Cmc)
By Biopeptek Pharmaceuticals LLC At Malvern, PA, United States
80% employer-paid MEDICAL HMO plan
80% employer-paid DENTAL PPO plan
We are in works to add 100% employer-paid Basic Life/AD&D + ST Disability
We will eventually also add a Medical PPO plan
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 Manager Jobs
By Mira At Washington, 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
Regulatory Affairs Manager Jobs
By Ardelyx, Inc. At Fremont, CA, United States
Develop and maintain knowledge of regulatory requirements and industry trends independently and with line manager.
Ability to interpret and understand regulatory and cGXP requirements and apply to regulatory submissions and job duties.
Experience in FDA CMC submissions utilizing eCTD format and electronic submissions.
Proficient in Microsoft Suite products, experience with VEEVA RIM preferred.
Ability to independently manage timelines in a project team environment.
Maintain awareness of and expertise in FDA and ICH guidelines related to regulatory topics.
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
Regulatory Affairs Cmc Scientist 1/Manager
By Daiichi Sankyo, Inc. At Basking Ridge, NJ, United States
5-8 years pharmaceutical industry experience with 2+ years direct or related CMC regulatory experience
Basic knowledge of regulations/guidance documents and pharmaceutical development process.
Strong oral and writing skills. Able to compile early/simple submission under supervision.
B.S. in a scientific discipline, graduate degree in a scientific discipline preferred
Join a Legacy of Innovation 110 Years and Counting!
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.
Senior Manager, Cmc Program Management
By Alexion Pharmaceuticals, Inc. At Boston, MA, United States
Strong track record in executing effective program management skills in cross-functional matrix organizations.
Demonstrated success in creating and managing complex program plans, including experience with global teams, budgetary management, resource planning, and risk management.
Provides key updates on program risks, progress and mitigation plans to management as needed.
Responsible for program/project level budgeting and resource management
Leads operational project management for CMC alliance or co-development programs, including contributing roles on alliance sub-committees and steering committees.
Prepares and manages governance interactions in partnership with the CMC Lead.
Associate Director, Regulatory Cmc
By BioSpace At San Diego, CA, United States
Strong sense of planning and prioritization, and the ability to work with all levels of management.
Ensure that CMC content is complete, well-written, and meets all relevant requirements.
Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP/quality investigations throughout development.
Biologics experience required; cell or gene therapy experience strongly preferred. Medical device experience also preferred.
Excellent interpersonal skills to communicate difficult concepts and persuade others.
Strategic thinking and strong problem-solving skills with outstanding attention to detail.
Associate Director Global Regulatory Cmc - Cell Therapy
By Shepherd Regulatory Search At Greater Philadelphia, United States
Leads interactions with FDA and other Health Authorities for CMC-related topics (including management of regulatory deliverables and commitments).
Provides CMC Regulatory leadership, serving as an expert for global regulatory CMC requirements and emerging trends for cell therapy products.
Plans, execute, and manages regulatory CMC submissions, including BLA/MAA, INDs, CTAs/IMPDs, briefing documents, and responses to queries.
Minimum of 10 years of pharmaceutical/biotech experience, including five years of Global Regulatory Affairs (CMC) experience.
Experience as a RA CMC product lead.
Experience in Cell or Gene Therapy.
Associate Director Global Regulatory Cmc - Cell Therapy
By Shepherd Regulatory Search At Greater Boston, United States
Leads interactions with FDA and other Health Authorities for CMC-related topics (including management of regulatory deliverables and commitments).
Provides CMC Regulatory leadership, serving as an expert for global regulatory CMC requirements and emerging trends for cell therapy products.
Plans, execute, and manages regulatory CMC submissions, including BLA/MAA, INDs, CTAs/IMPDs, briefing documents, and responses to queries.
Minimum of 10 years of pharmaceutical/biotech experience, including five years of Global Regulatory Affairs (CMC) experience.
Experience as a RA CMC product lead.
Experience in Cell or Gene Therapy.
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
Cmc Project Manager Jobs
By Integrated Resources, Inc ( IRI ) At Warren, NJ, United States
Apply project management expertise across the portfolio for standard and complex projects, managing multiple projects in parallel.
Strong knowledge of biopharma industry. Familiarity/experience with end-to-end CMC drug development.
Report on project progress, offer viable solutions and opportunities as they arise
Work with internal and external stakeholders to manage project deliverables, e.g., CMOs, Supply Chain, etc.
Excellent interpersonal, communication, and presentation skills.
Strong leadership skills and executive presence; ability to positively influence outcomes.
Senior Manager Regulatory Affairs
By Smith Hanley Associates At Chicago, IL, United States
Senior Manager, Regulatory Affairs (Advertising & Promotion)
Assures timely and accurate review of advertising and promotional material to meet internal timelines and requirements.
5+ years of pharmaceutical experience with 3+ years of pharmaceutical advertising and promotion experience.
Knowledge of the pharmaceutical industry, Regulatory Affairs for prescriptions drugs.
Knowledge of the pharmaceutical product NDA and labeling processes.
Strong interpersonal skills with the ability to influence others.
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 ...

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