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Regulatory Affairs Associate Jobs

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
Senior Regulatory Affairs Associate/Specialist
By SciPro At San Diego, CA, United States
Be able to provide support to regulatory management and project teams and implement regulatory strategy while delivering documentation on time.
Maintain and manage databases containing regulatory information, submissions, and correspondence.
BS in life sciences with a minimum of 3 years of experience in Regulatory Affairs
Experience submitting IND filings utilizing eCTD formatted submissions highly desirable.
Independently plan daily work to complete time-sensitive assignments while following general instructions for project completion.
Review documents necessary for the regulatory site documentation related to the shipment of drug products to clinical sites.
Regulatory Affairs Associate (Remote)
By Gardner Resources Consulting, LLC At Princeton, NJ, United States
• Experience with submission work in VaultRim
• Experience with RA compliance reports including (NDA, BLA, ODD, DSUR, PBRER annual reports)
Qualified applicants will have the following expertise:
Associate Regulatory Affairs Specialist
By McKesson At Irving, TX, United States
Ability to use project management tools, including Smartsheet & SharePoint
Advanced MS Office (Word, PowerPoint, Excel) skills
Strong communication and collaboration skills
Demonstrated ability to manage multiple work streams
Prior experience in a compliance or regulatory function preferred
Typically, a minimum of 1-3 years of relevant experience. May have a degree or equivalent
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.
Regulatory Affairs Associate Jobs
By Inari At West Lafayette, IN, United States
Track and manage documentation for the Regulatory Project Plans including agency consultation,
Support variety registration when applicable and verify data needs and generation. Manage filing
Support Regulatory Intelligence activities and tracking evolution of data requirements and
Monitor Regulatory competitor activities and access to information where available. Manage the
Solid experience in biological sciences, preferably agricultural sciences, or related disciplines;
3-5 years of work experience in agricultural or microbial biotechnology
Regulatory Affairs Associate Jobs
By CellCarta At Naperville, IL, United States
Detail-oriented with good organization and time management skills.
Make decisions related to work processes or operational plans and schedules in order to achieve program objectives established by senior management.
Develops regulatory processes and procedures aligned with global regulatory requirements and train key personnel in accordance with these processes and procedures.
Develops and maintains product labeling (e.g. technical information summaries, instructions for use etc.), advises team on labeling requirements.
Utilize technical regulatory skills to propose strategies on complex issues.
Determine submission and approval requirements.
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.
Clinical Regulatory Affairs Associate
By Compliance Group Inc At Plano, TX, United States
EDUCATION AND EXPERIENCE YOU’LL BRING
Strong organizational and follow-up skills, as well as attention to detail.
Experience writing clear and concise technical documents.
Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
May interface directly with FDA and other regulatory agencies.
Work with cross-functional team to support product release process.
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 Jobs
By Intellectt Inc At Alameda County, CA, United States
May require an advanced degree and 5-8 years of direct experience in the field.
Recent experience with Class III implantable medical devices
Knowledge of FDA PMA guidance documents and CFR regulations.
Relies on extensive experience and judgment to plan and accomplish goals.
Typically reports to a manager or head of a unit/department.
knowledge of FDA PMA guidance documents and CFR regulations.
Regulatory Affairs Associate Jobs
By Mindlance At Plano, TX, United States
Science (biology, chemistry etc.) preferred. (Or Equivalency, special qualifications, certifications, licenses, etc.)
Specific Responsibilities Receive documents from various sources and review for completeness and suitability for submission to FDA.
Review regulatory documents to assure FDA requirements are met and are ready for submission
With the manager's guidance, prepares new IND, NDA and SNDA submissions, amendments and supplements.
Needs to be able to organize and prioritize tasks and work independent of manager.
With more complex tasks/submissions, work with the manager to accomplish goals/tasks.
Regulatory Affairs/Compliance Assistant
By CitiStaffing At New York City Metropolitan Area, United States

Provide administrative support to the COO/Head of Trading Surveillance, Regulatory Affairs & Compliance.

Associate Director, Regulatory Affairs, Supply Chain
By Avanos Medical At California, United States
Provide leadership to maintain compliance with domestic and international regulations as well as management of the Avanos Mexico facilities’ State Licenses.
Continue to increase education/knowledge in the area of Regulatory Affairs.
Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do;
Eight to ten years experience in Regulatory Affairs.
Exceptional written and verbal communication skills.
Team player with excellent organizational skills.
Senior Regulatory Affairs Associate, Fsp
By Parexel At , Remote
Management Strong management with depth of experience working for global health authorities.
Experience with project lifecycle and management
Strong management with depth of experience working for global health authorities.
Interacts with the assigned Project Assistant (PA) to ensure accurate financial management and for general project support.
Interacts professionally at multiple levels including senior management within a client organization.
Successfully penetrates executive management levels or other business units within a client organization.
Regulatory Affairs Associate Jobs
By ABBVIE At , , Il
NOTE: Higher education may compensate for years of experience. Years of experience may also compensate for lower education
Liaises with vendors to communicate and coordinate legalization of documents in accordance with country requirements.
Receives projects from manager but has responsibility for managing own projects with oversights
Reviews project progress with manager on a regular basis and escalates issues
Required Education: Bachelor’s Degree in life sciences
Required Experience: 2 years pharmaceutical or industry related experience
Regulatory Affairs Associate Jobs
By BioSpace At North Chicago, IL, United States
NOTE: Higher education may compensate for years of experience. Years of experience may also compensate for lower education
Liaises with vendors to communicate and coordinate legalization of documents in accordance with country requirements.
Receives projects from manager but has responsibility for managing own projects with oversights
Reviews project progress with manager on a regular basis and escalates issues
Required Education: Bachelor’s Degree in life sciences
Required Experience: 2 years pharmaceutical or industry related experience
Regulatory Affairs Associate Jobs
By Institutional Shareholder Services At , Rockville, 20850, Md
Bachelor’s degree with a strong academic record. Relevant internship or professional (e.g., public policy, economics, finance) experience.
We are proud to offer the following featured benefits
Excellent communication, both written and oral, and analytical skills.
FSA and Commuter benefit programs
Working with members of the ISS Regulatory Affairs team and internal stakeholders to identify policy risks and opportunities.
Tracking, synthesizing, and summarizing legislative and regulatory developments and proceedings, including for non-technical audiences.
Regulatory Affairs Associate - Remote
By UnitedHealth Group At , Eden Prairie, 55344, Mn $22.45 - $43.89 an hour
Proven organized and solid time management skills
2+ years of direct Medicaid and Medicare pharmacy licensing/enrollment experience
Experience with interacting and collaborating with a variety of stakeholders and in a team setting
Ability to comprehend state and federal requirements and regulations
Experience in a pharmacy or clinical setting
Proven solid problem solving and analytical skills

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