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Regulatory Project Manager Jobs

Regulatory Manager Jobs
By altafiber At Cincinnati, OH, United States
Special Knowledge, Skills and Abilities:
Strong analytical skills and demonstrated problem-solving abilities
Good working knowledge of Company operations, processes, products and services Solid PC Skills, including Excel, Word, PowerPoint
Develops and implements regulatory guidance strategies for new and existing product and service offerings to meet business objective. (20%)
Strong interpersonal skills in order to interact professionally with Commission Staff, Industry Associations/Coalitions, internal departments and other external stakeholders as required.
Knowledge of current regulatory issues, rules and environment (Federal and State)
Manager, Member Regulatory Communications
By Oscar Health At New York, NY, United States
Promoting cross-training, knowledge management, and problem-solving across the organization.
5+ years of experience in program management, design, implementation or ongoing operations management
Experience in a client facing/vendor management role
Assist the Sr. Manager with project management for cross-functional initiatives.
(A bachelor's degree or commensurate 4 years of experience
5+ years of work experience in health insurance, consulting, healthcare, and operations
Project Manager (With Regulatory Compliance)
By Ameex Technologies At Los Angeles, CA, United States
Manage overall project organization to ensure requirements and project deliverable dates can be clearly communicated.
Provide ongoing program and project management support.
Expert communication, status reporting, plan management and execution.
Create project timelines, and manage creative, development milestones and deliverables.
Create/manage project plans in Microsoft Project, drive all tasks, holding stakeholders accountable
Minimum of 10 years’ experience leading projects within a strong Regulatory and Compliance experience.
Regulatory Manager Jobs
By CHT Group At Cassopolis, MI, United States
EDUCATION, TRAINING AND EXPERIENCE REQUIREMENTS
• Provide research, interpretation, and summary of regulatory requirements relevant to regulated substances.
• Provide education and training on product compliance with regulations for sales, Client Development, and Business Development.
• Author CHT USA Safety Data Sheets to ensure full compliance with US and other country requirements.
o 5-7 years of industrial chemistry experience
o 2-3 years of regulatory experience preferred
Regulatory Manager Jobs
By OPIS At United States
Manage all the databases, as per local regulation (e.g. EudraCT European database and EudraCT number request, ClinicalTrials.gov)
If necessary, directly manage ethical/administrative submissions
Conduct with his/her direct Manager annual performance review for his/her staff and provide career development opportunities
Degree level education is a plus preferably in pharmacy, medicine, or biological sciences
Minimum of 3 years professional experience, including previous experience in Regulatory or Start-up functions at a local/country level
At least 1 years of hands-on experience in the submission of clinical trial applications
Senior Regulatory Project Manager
By Amotec Inc. At Clearwater, FL, United States
Provide strategic project management insights on short and long term global regulatory projects
Must have medical device experience and knowledge (Class 1 and/or Class 2 a plus)
Bachelor's Degree with 3-5 years of regulatory experience or Master's degree/PhD with 2-3 years of regulatory experience
Supplying regulatory advice and updates to both internal and external stakeholders
Lead post approval submission amendments and yearly reporting for regulatory compliance
Develop new systems to continuously improve and drive change
Regulatory Project Manager Jobs
By Black Diamond Networks At United States
Assist to ensure roles and responsibilities for project team members are clearly documented.
Assist submission working group cross functional meetings to drive decision making and project execution.
Ensure creation of agendas, meeting minutes, and tracking/resolution of action items.
Proactively provide status updates to designated stakeholders via dashboards and milestone reports, and ensure leadership is aware of critical considerations
Assist to ensure overall regulatory project timelines are aligned cross-functionally and support the coordination of timely regulatory submissions.
IND / BLA / MAA / CTA
Regulatory Project Coordinator Jobs
By Entegee At Minneapolis, MN, United States

Ensures timely and quality completion of regulatory data forms verifying data as well as identifying

The Company will consider qualified applicants with arrest and conviction records.

Regulatory Project Coordinator Jobs
By Redbock - an NES Fircroft company At United States
Manages schedules, reviews status of projects, and prepares status reports on an ongoing basis
4 years of administrative/project support experience
MDR- Project Coordinator III (Regulatory) (Through end of April 2024 // REMOTE, team based in MA):
Ensures timely and quality completion of regulatory data forms verifying data as well as identifying, managing, and resolving data discrepancies
Tracks project timeline and global regulatory submission data
Maintains file-specific correspondence and other required documentation
Regulatory Manager / Director Jobs
By Healcisio Inc. At San Diego, CA, United States

Working knowledge of ISO 13485 and Internal & External Auditing

Experience with Machine Learning (ML), artificial intelligence (AI) and Software as a Medical Device (SaMD)

Remote: Backfill- Regulatory Project Manager (233243)
By Black Diamond Networks At United States

Job Description Our client is looking for a 2-5 year Regulatory Project Manager to support their growing regulatory team on multiple drug submissions. This role oversees the management, tracking ...

Project Manager, Food Contact Regulatory (Remote)
By RemoteWorker US At Boca Raton, FL, United States

Position: Project Manager, Food Contact Regulatory Location : Remote Who We Are and What We Do? Intertek Assuris provides consultation and research services to global, brand-name companies involved in ...

Associate Regulatory Manager Jobs
By BODYARMOR Sports Nutrition At Queens, NY, United States
Base pay offered may vary depending on geography, job-related knowledge, skills, and experience.
Oversee all product certifications that include Kosher, NSF, SQF, etc.
Manage raw and pack supplier and material approvals to ensure safe, quality materials are always used.
Oversee the improve the regulatory claims and certification process for accuracy to support continuous processes and performance of BODYARMOR products.
4 years’ experience in Regulatory Affairs in the food or beverage industry required
4 years’ experience in Quality roles ideally in supplier quality or food safety in the food or beverage industry required
Manager, Regulatory Strategy Jobs
By bluebird bio At United States
Preparing submission plans and manage timelines for regulatory submissions
2+ years of regulatory experience in a biotech/pharma company, preferably in biologics
Knowledgeable in FDA and ICH guidelines
Knowledge of Good Clinical Practice and current Good Manufacturing Practices (GMP) preferred
Assisting in coordination and preparation for regulatory agency meetings and associated briefing document preparation,
Managing regulatory submission process, documentation, submission logs and archiving
Wireless Regulatory And Real Estate Project Manager
By Verizon At , Irvine, 92618, Ca $81,000 - $151,000 a year
Project Management Professional (PMP) Certification.
Experience in Project Management/Reporting Tools (Fuze SPM, Tableau, etc.)
Bachelor's degree or four or more years of work experience.
Three or more years of relevant work experience.
Six Sigma Green Belt or Black Belt Certification.
Experience in project leadership, including successful project/program launches and conclusions.

Are you looking for an exciting opportunity to manage regulatory projects and help shape the future of the industry? We are looking for a Regulatory Project Manager to join our team and help us develop and implement innovative solutions to regulatory challenges. You will have the chance to work with a diverse team of professionals and make a real impact on the industry. If you are passionate about regulatory compliance and have the skills to lead projects, then this is the job for you!

Overview:

Regulatory Project Managers are responsible for managing the regulatory aspects of projects in the pharmaceutical, biotechnology, medical device, and other related industries. They are responsible for ensuring that projects are compliant with all applicable regulations, and for providing guidance and support to project teams.

Detailed Job Description:

Regulatory Project Managers are responsible for managing the regulatory aspects of projects in the pharmaceutical, biotechnology, medical device, and other related industries. They are responsible for ensuring that projects are compliant with all applicable regulations, and for providing guidance and support to project teams. Regulatory Project Managers must have a thorough understanding of the regulations and standards that apply to their projects, and must be able to interpret and apply them to ensure compliance. They must also be able to identify potential risks and develop strategies to mitigate them. Regulatory Project Managers must be able to communicate effectively with project teams, regulatory authorities, and other stakeholders, and must be able to manage multiple projects simultaneously.

What is Regulatory Project Manager Job Skills Required?

• Knowledge of applicable regulations and standards
• Ability to interpret and apply regulations and standards
• Ability to identify potential risks and develop strategies to mitigate them
• Excellent communication and interpersonal skills
• Ability to manage multiple projects simultaneously
• Strong organizational and problem-solving skills
• Ability to work independently and as part of a team

What is Regulatory Project Manager Job Qualifications?

• Bachelor’s degree in a related field
• At least 5 years of experience in a regulatory role
• Knowledge of applicable regulations and standards
• Experience in project management
• Excellent communication and interpersonal skills

What is Regulatory Project Manager Job Knowledge?

Regulatory Project Managers must have a thorough understanding of the regulations and standards that apply to their projects, and must be able to interpret and apply them to ensure compliance. They must also be able to identify potential risks and develop strategies to mitigate them.

What is Regulatory Project Manager Job Experience?

At least 5 years of experience in a regulatory role is required for this position.

What is Regulatory Project Manager Job Responsibilities?

• Ensure compliance with applicable regulations and standards
• Identify potential risks and develop strategies to mitigate them
• Provide guidance and support to project teams
• Communicate effectively with project teams, regulatory authorities, and other stakeholders
• Manage multiple projects simultaneously
• Monitor project progress and provide updates to stakeholders