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Regulatory Affairs Associate Jobs in Union, Arkansas

Regulatory Data Associate Jobs
By Oscar Health At United States
3+ years of experience in project management for complex data requests
3+ years of experience partnering with stakeholders to understand requirements and translate into data insights
Ensure data governance best practices are developed and followed consistently in adherence to compliance and regulatory requirements.
3+ years of experience in critical execution of data requests with unclear parameters
Direct experience with BigQuery and python
Healthcare, Clinical Informatics, Banking, or Insurance experience
Associate, Regulatory Implementation Jobs
By Oscar Health At United States
Meet with stakeholders to discuss program status and goals applying project management skills most effective for the given implementation
3+ years of project management experience or operational experience
Experience reading regulations and identifying operational impact
PMP and/or Six Sigma Certification
Track a diverse range of regulatory change implementations using designated tooling
Make recommendations to improve processes and tooling
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 Associate Jobs
By Voltus At United States
Excellent project management skills. Must be incredibly efficient while also exercising judgment in allocating limited resources.
1-2 years experience in the energy sector preferred, with some working knowledge of the wholesale markets.
Master our business by working across the organization (Operations, Energy Markets, Engineering) and use that knowledge in advocacy.
Excellent written and verbal communication skills, effectively distilling complex ideas. Comfortable with basic data analysis.
Graduate degree (e.g., J.D. or Masters Degree) strongly preferred, or equivalent experience, with 0-2 years of post-degree work experience.
Work with cross-functional teams, especially Energy Markets, to develop these communications.
Associate Manager, Regulatory Technology
By BeiGene At United States
Working knowledge of drug development and submission requirements
Proficient in Document management and RIMS (Veeva RIM Suite Preferred)
Maintain up-to-date knowledge of global standards and procedures for regulatory submissions publishing processes
Bachelors degree or equivalent experience required
Experience in managing day-to-day administration of regulated systems
Excellent written, verbal, and interpersonal communication skills
Regulatory Affairs Associate Jobs
By Hilco Vision At United States
Possible expansion to assist with pre-market management of one or more product lines
You have a BS degree with 0 - 2 years of experience working with Regulatory and Compliance data
You have strong computer skills, including the MS Office suite, and have an aptitude to learn M3, or other ERP systems
You have a strong commitment to integrity, ethical business conduct, and legal compliance.
You’re familiar with researching legislation and regulatory guidance
You’re adept at managing sensitive and confidential information, and are able to balance multiple priorities and assignments when needed
Remote Regulatory Affairs Associate (Medical Device)
By The Fountain Group At United States
100% remote must be okay work PST hours.
1-2+ years of Regulatory affairs medical device experience (Must be post grad experience)
Global APAC regulatory submission (Japan /China experience) required
Post grad experience with regulatory submissions
Experience with IVDs is preferred
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
Associate Director Regulatory Affairs
By GQR Global Markets At United States
Manage submission plans and timelines to ensure approvals are timely and development objectives are met .
Manage regulatory data and information within systems .
Strong scientific background with at least five (5) years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries.
Proven ability to successfully manage major submissions and critical projects to deadlines.
Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects).
Represent and coordinate regulatory information as a team member, covering clinical, non-clinical, CMC, labeling, and post-approval change activities .
Regulatory Affairs Associate (Consumer Products)
By The Fountain Group At United States
Rate $40-45 an hour depending on experience.
100% remote – CST hours preferred.
A bachelor’s degree in a life science discipline and 3+ years of relevant regulatory experience, including FDA and Health Canada regulations.
Regulatory experiences on Class I Medical Device or Consumer Products or Cosmetic Products.
Provide regulatory support on Labeling and Ad Promo (Artwork/copy doc.) reviews and approvals.
Provide regulatory support with procedures/SOP development and continuous improvements.
Regulatory Affairs Associate Ii
By Integrated Resources, Inc ( IRI ) At United States
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• Manage the application and communication of all *** policies, procedures, and *** Way of Management.
• Effective personal time management.
LOCATION: Can be 100% Remote (or Hybrid/Plainsboro, NJ)
• Experience with submission work in VaultRim
• Experience with RA compliance reports including (NDA, BLA, ODD, DSUR, PBRER
Sr Regulatory Affairs Consultant
By Mittal Consulting LLC At United States
Manage multiple, parallel projects to successful completion
Experience with PMAs is required
Client centered focus and problem solving skills
Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously
Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
Minimum 5 years of related regulatory experience, including:
Regulatory Affairs Submissions Supervisor
By EPM Scientific At United States
Supervise submission management, labeling processes, RIMS, regulatory intelligence, certificates of pharmaceutical product, among reg. operational activities.
Work with project managers, reg. product managers, and/or content authors to discuss submission preparation.
Support labeling projects including: FDA labeling requirements, Structured Product Labeling (SPL), drug listing, and establishment registration activities.
Organize and ensure training on labeling process & technology - for labeling user communities, internal teams, vendors, partners, affiliates, stakeholders.
Regulatory Affairs Intern Jobs
By Flywheel.io At United States
Assist with researching regulatory compliance requirements, reviewing company policies, standards, procedures, and training material.
Other responsibilities as required and assigned by the Executive Director of Regulatory Affairs
A reliable self starter with exceptional computer and software skills
Experience with employee training programs for multiple compliance standards
Any compliance and regulatory functional experience in biomedical informatics supporting clinical trials both nationally and internationally
Assist in overseeing an employee regulatory compliance training program following a responsibility matrix while maintaining accurate training records.
Regulatory Affairs Associate I
By SPECTRAFORCE At United States
• Administrative and project management skills
What are your top three to five technical skill requirements?
• Maintain awareness of regulatory requirements and ensure continued learning
• Maintain regulatory files in a format consistent with requirements
• Interpersonal and communication skills
• Technical system skills (e.g. word processing, spreadsheets, databases, online research)
Summer Intern, Regulatory Affairs
By Planet Pharma At United States
Intern Qualifications and SkillsPursuing a bachelor’s, or graduate degree in life sciences
Ability to manage workload effectively including planning, organizing, prioritizing, and meeting deadlines
Ability to apply scientific and/or business knowledge to assigned projects
Effective writing skills, with high attention to detail
Review of Global Regulatory submission documents to obtain correspondence information and feedback between the company and the health authority agency
Prepare a final presentation on research, and overall learning through the internship project for the intern symposium
Regulatory Affairs Associate Jobs
By Agilent Technologies At California, United States
Compile materials required in submissions, license renewal and annual registrations and maintains updated information about national/regional/global regulatory requirements.
Maintain and updates information about global regulatory requirements.
4+ years of Regulatory Affairs experience
Post-graduate and/or certification/ license may be required.
Review product labeling and marketing materials for accuracy and compliance with regulations.
Respond to customers and/or authorities requests/inquiries dealing with regulations and product compliance.
Regulatory Affairs Associate Jobs
By Earth Animal At Southport, CT, United States
Identify claims issues and lead/offer alternatives to comply with regulatory guidelines while supporting business needs.
Must be a solution oriented, self-starter with demonstrated problem solving skills.
Skilled in Excel and demonstrate accuracy with collecting and analyzing data.
Responsibilities include but are not limited to:
Lead regulatory functions and collaborate with cross-functional partners in support of the marketing review and documentation proofing process.
Regulatory Claim Subject Matter Expert (Marketing Support and Review)
Regulatory Affairs Associate Jobs
By Aditi Consulting At Plainsboro, NJ, United States
Knowledge of FDA and Health Canada eCTD submissions lifecycle management and associated guidance’s/specifications/regulations.
Reports to labeling management in Regulatory Operations and Innovation.
Enters and monitors project and data in Regulatory Label Management systems (LIFT, SPL, ALiCE, novoGlow, etc.).
May be responsible for managing projects, processes, or programs with manager oversight.
Experience and/or Familiarity with Structured Content is preferred
Excellent verbal and written communication and skills.
Associate Iii, Regulatory Affairs
By Sandoz At , Princeton $97,600 - $146,400 a year
Effectively monitor and track information and requirement changes
Maintain compliance with regulatory requirements and regulatory databases for generic drugs for the US market.
Adhere to all health, safety & environmental (HSE) requirements in support of departmental and site HSE goals
Excellent oral and written communication skills
Pharmaceutical or generic drug experience in a regulatory capacity
Lab experience and familiarity with Abbreviated New Drug Application (ANDA) and/or Electronic Common Technical Document (eCTD)
Regulatory Affairs Associate Jobs
By Fred Hutchinson Cancer Center At , Seattle, 98109 $70,817 - $106,225 a year
Skilled in the use of clinical trials and electronic document management systems
Assure the proper management, retention, and version control of all applicable regulatory documentation including master files and amendments.
Assist with sponsor monitoring visits remotely and onsite as needed.
Perform other responsibilities as assigned.
Bachelor’s Degree in a related field or equivalent experience
Knowledge of US FDA regulations and guidelines that govern clinical research (GCP/ICH and IRB)

Are you looking for an exciting opportunity to join a growing Regulatory Affairs team? We are looking for a Regulatory Affairs Associate to join our team and help us ensure compliance with regulatory requirements. You will be responsible for preparing and submitting regulatory documents, monitoring regulatory changes, and providing guidance on regulatory requirements. If you have a passion for regulatory affairs and are looking for a challenging and rewarding role, this could be the perfect job for you!

A Regulatory Affairs Associate is responsible for ensuring that a company’s products comply with all applicable laws and regulations. This includes researching and interpreting regulations, preparing and submitting regulatory documents, and providing regulatory support to other departments.

What is Regulatory Affairs Associate Skills Required?

• Knowledge of applicable laws and regulations
• Excellent research and analytical skills
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Ability to manage multiple projects and prioritize tasks
• Attention to detail
• Proficiency in Microsoft Office

What is Regulatory Affairs Associate Qualifications?

• Bachelor’s degree in a related field such as biology, chemistry, or engineering
• Regulatory Affairs Certification (RAC) is preferred

What is Regulatory Affairs Associate Knowledge?

• Knowledge of FDA regulations and guidelines
• Knowledge of international regulatory requirements
• Knowledge of Good Manufacturing Practices (GMPs)

What is Regulatory Affairs Associate Experience?

• Previous experience in a regulatory affairs role is preferred
• Experience in the pharmaceutical or medical device industry is a plus

What is Regulatory Affairs Associate Responsibilities?

• Research and interpret applicable laws and regulations
• Prepare and submit regulatory documents
• Monitor changes in regulatory requirements
• Provide regulatory support to other departments
• Maintain regulatory records
• Liaise with regulatory agencies
• Ensure