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Regulatory Affairs Assistant Jobs

Director Regulatory Affairs Jobs
By Altasciences At United States
Critical thinking skills and ability to acquire and apply knowledge quickly;
Lead, manage and prepare clinical trial submissions;
Lead, manage, prepare, and submit meeting requests and meeting information packages to health agencies;
Lead, manage, prepare, and submit controlled correspondence to regulatory agencies;
8+ years of regulatory experience in an industry setting;
Strong knowledge of drug development and regulatory policy;
California Regulatory Affairs Analyst (Hybrid)
By California ISO At Folsom, CA, United States
Level of Education and Discipline:
Participate in paid on-call rotation and other job-related duties as assigned.
May perform related duties and activities as assigned.
Adheres to and supports the Core Values of the ISO.
Regulatory Affairs Consultant (Freelance)
By Alien Technology Transfer At United States
Provide training to company managers and other relevant team members in areas related to regulatory compliance and associated best practices;
Conduct thorough research and stay up-to-date with US regulatory requirements, guidelines, and industry best practices pertaining to healthcare products and pharmaceuticals.
Minimum of 5 years of experience as a Regulatory Affairs Consultant in the healthcare industry, with a focus on US regulations;
In-depth knowledge of US FDA regulations and guidelines for drug and medical device development and approval processes;
Exceptional research, analytical, and problem-solving skills;
Excellent written and verbal communication skills;
Assistant Director Of Regulatory Affairs
By NC Real Estate Commission At West Bend, NC, United States

Attorney needed to assist division director with supervisory and managerial responsibilities and to prosecute cases involving allegations of violations of Real Estate License Law and Commission ...

Regulatory Affairs Lead Jobs
By Bramwith Consulting At United States
Bachelors degree in a scientific discipline or relevant experience (post-graduate degree is preferred but not a requirement)
Experience working within US regulatory affairs within the pharmaceutical or healthcare industry
Experience of regulatory submissions and approvals, including new BLAs/NDAs
Experience with licensing including negotiating directly with the FDA
Salary - $150,000 to $160,000 plus excellent bonus and benefits
across their entire business. As part of this growth, the business is looking to hire an experienced
Regulatory Affairs Strategist Jobs
By Navitas Life Sciences At , Remote
Develop and manage day-to-day operations using project management and planning tools, create and maintain detailed project timelines
Support delivery in performing project management activities or as an individual contributor for a deliverable, managing relationships with all stakeholders
Sound understanding of regulatory information management concepts and tools needed to perform regulatory operations priorities in support of all business areas
Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements
There is a travel requirement of up to 10%
Knowledge of IND/NDA/BLA submissions and life cycle submissions for the US market
Regulatory Affairs Lead Jobs
By Bramwith Consulting At Massachusetts, United States
Ensure sustained quality and efficiency through modern artwork management systems
Extensive experience working with Healthcare/Pharmaceutical product labelling
Consistently drive continuous improvement related to global Pharmaceutical labelling
Work highly cross-functionally with wider global teams, and educate global stakeholders of labelling best practices
Strong understanding of Pharmaceutical Regulatory Bodies across a global remit
Degree from a leading college
Regulatory Affairs Analyst Jobs
By San Jose Water At San Jose, CA, United States
Required Knowledge Skills & Abilities
· Working knowledge of statistics, investments, budgeting, project management and computerized applications.
· The Regulatory Affairs Analyst requires substantial technical skill in finance, economics, and statistics.
· Utility rate-making methodologies and legal requirements.
· Excellent written and oral communication skills.
· A bachelor's degree or equivalent in finance, economics, accounting, engineering or a closely related field.
Regulatory Affairs, Noram Jobs
By Biocon Biologics At New Jersey, United States
Minimum 12 years relevant experience out of which more than 5 years of people manager role
Responsible for Noram regulatory strategy of both products approved and products under development.
Will serve as the point of contact for the Agency’s interactions and act as local regulatory representative
Supports development of Noram regulatory policy priorities, generates policy positions, develops action plans.
Responsible to prepare, review and approval of module 1 sections in partnering with GRL and make them available for NDS submission
Assist North America head on product development strategy and participate in building the regulatory strategy.
Regulatory Affairs Consultant - Usa Remote
By Alien Technology Transfer At ,
Provide training to company managers and other relevant team members in areas related to regulatory compliance and associated best practices;
Conduct thorough research and stay up-to-date with US regulatory requirements, guidelines, and industry best practices pertaining to healthcare products and pharmaceuticals.
Minimum of 5 years of experience as a Regulatory Affairs Consultant in the healthcare industry, with a focus on US regulations;
In-depth knowledge of US FDA regulations and guidelines for drug and medical device development and approval processes;
Exceptional research, analytical, and problem-solving skills;
Excellent written and verbal communication skills;
Regulatory Affairs Professional Jobs
By Sartorius At , Remote
Deep knowledge of the relevant Regulatory requirements
Opportunity for international career development: a global network offering seminars and training sessions, expert and manager career paths
8+ years relevant experience within the Regulatory Affairs discipline
Ability to develop innovative strategies and creative solutions within the Regulatory context and within the scope of requirements/available resources.
Proven analytical skill and technical/scientific competence.
Strong initiation and organizational skills
Regulatory Affairs Complaint Investigator (Fda)
By ZOLL LifeVest At , Pittsburgh, 15238
Experience with Microsoft Access Preferred
Strong knowledge of Microsoft Excel, Word, Outlook, and Adobe Acrobat software.
Location: Remote, PA, United States of America
Liaise with the distributor, service, and engineering departments in acquiring relevant information for complaint investigations.
Compile complaint investigation information for final RAE review and approval.
Provide administrative support during product recall notifications, advisory reports, and incident reports.
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
Regulatory Affairs Leader Jobs
By GE HealthCare At Chicago, IL, United States
Professional experience in regulatory project management/program management and regulatory agency interactions.
Demonstrated life-long learner; eagerness to obtain new skills and knowledge.
Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
Proved work experience in heavily regulated fields such as medical devices, pharmaceuticals, or biologics.
Professional experience in Regulatory Affairs / Quality Assurance.
Experience with Software as a Medical Device (SaMD), cybersecurity, and other non-device software products.
Regulatory Affairs Scientist – Nutritional Supplements
By Wellington Executive Search At Denver, CO, United States
Communicate to the Operations Manager, Director of Quality, or other Senior Management as appropriate any potential issue.
An experienced formulation and applications team
Prior experience working with documentation pertaining to nutritional supplements and ingredients
Good analytical problem-solving skills. Meticulous with follow-up
Good communication skills. Able to give clear directions to others.
Quality Assurance, Compliance, Labelling, Documentation, and Regulatory Requirements
Regulatory Affairs Consultant Jobs
By Life Science People At United States
Experience with prep and filing of the following applications: FDA IND/ANDA/NDA/BLA applications and maintenance submissions
Experience with leading cross-functional teams
As the roles can range, it would be ideal to have experience with the following:
5+ years in Regulatory Affairs (ex: generics, prescription drugs and biologics)
May require up to 10% travel
This would be a contract role, and they are open to either full-time or part-time capacity.
Regulatory Affairs Consultant Jobs
By Connect Life Science At Boston, MA, United States
Solid experience of software and SaMD regulatory requirements for medical devices
Familiarity with software development life cycle methodologies, risk management, and QMS.
Provide guidance and support to cross-functional teams in the interpretation and implementation of software regulatory requirements, standards, and guidelines
Remote/Hybrid with site visits to Boston, MA
Medical Device & IVD Experience
Liaise directly with FDA to ensure successful 510K and product clearance
Scientific And Regulatory Affairs
By Randstad USA At Chicago, IL, United States
Support regulatory change management by performing key ingredient searches in the database to evaluate the impact of regulatory change
Supportive management invested in your success
2-3 years of experience in regulatory affairs at a food, beverage, or consumer product company
Experience in International regulatory, Dragonfly/yellowfin, MS Office
What are your daily job duties:
Screen and approve new ingredients per the aligned service level agreement to ensure data accuracy
Regulatory Affairs Liaison Jobs
By EPM Scientific At United States
In-depth knowledge of relevant national and international regulatory requirements, guidelines, and standards, such as FDA, EMA, ISO, etc.
Proficient in using regulatory databases, document management systems, and other relevant software tools.
Familiarity with quality management systems (QMS) and regulatory compliance auditing is a plus.
Coordinate and manage regulatory submissions, including applications, registrations, notifications, and reports, ensuring completeness, accuracy, and adherence to specified timelines.
Conduct thorough research and analysis of regulatory requirements, guidelines, and industry best practices as needed – to ensure regulatory compliance.
Keep abreast of changes in regulatory requirements and communicate updates and potential impacts to relevant departments within the organization.
Regulatory Affairs Consultants Jobs
By Pharmatech Associates, a USP company At San Francisco, CA, United States
Develop, lead, and drive the execution of the regulatory strategy from pre-IND to launch, commercialization and product lifecycle management
Responsible for communicating business-related issues or opportunities to next management level
Plan and oversee activities in support of all regulatory submissions
Provide regulatory guidance to the Client across all areas of regulatory affairs throughout all stages from product development
Participate as part of internal regulatory team to define and execute the regulatory strategy
Support the preparation of briefing packages, and regulatory submission documents as needed , providing insight and expertise

Are you looking for an exciting opportunity to join a dynamic Regulatory Affairs team? We are looking for a Regulatory Affairs Assistant to join our team and help us ensure that our products meet all applicable regulatory requirements. This is a great opportunity to gain valuable experience in the regulatory field and make a real impact on our business.

A Regulatory Affairs Assistant is responsible for providing administrative and technical support to the Regulatory Affairs department. This role involves ensuring that all regulatory requirements are met, and that all regulatory documents are accurate and up-to-date.

What is Regulatory Affairs Assistant Skills Required?

• Excellent organizational and communication skills
• Ability to work independently and as part of a team
• Proficiency in Microsoft Office Suite
• Knowledge of regulatory requirements and processes
• Attention to detail
• Ability to multitask and prioritize tasks

What is Regulatory Affairs Assistant Qualifications?

• Bachelor’s degree in a related field such as Regulatory Affairs, Science, or Business Administration
• Relevant experience in a regulatory affairs role

What is Regulatory Affairs Assistant Knowledge?

• Knowledge of FDA, EU, and other international regulatory requirements
• Knowledge of Good Manufacturing Practices (GMP)
• Knowledge of medical device regulations

What is Regulatory Affairs Assistant Experience?

• Previous experience in a regulatory affairs role
• Experience in medical device or pharmaceutical industry

What is Regulatory Affairs Assistant Responsibilities?

• Assist in the preparation and submission of regulatory documents
• Monitor regulatory changes and ensure compliance
• Maintain regulatory databases
• Assist in the preparation of regulatory reports
• Liaise with regulatory authorities
• Review product labeling and advertising materials for compliance
• Assist in the