Register
Recruit Create CV

Regulatory Affairs Associate Jobs in San Francisco, California

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
Corporate Affairs Associate Jobs
By Arlite At San Francisco, CA, United States
Conducting thorough research on clients to understand their business needs and requirements.
Conducting industry research to identify trends and opportunities that may benefit the company.
Exceptional communication and writing skills
Conducting deal sourcing activities to identify potential business opportunities for the company.
Reaching out to potential clients and maintaining communication with existing clients to build relationships.
Drafting and preparing accurate and effective written documents, including emails, reports, and proposals.
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.
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 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.
Vp, Regulatory Affairs Strategy
By Exelixis, Inc. At , Alameda, 94502, Ca $313,000 - $363,000 a year
Monitor current and proposed regulatory issues and trends and advise management on events of significance for Exelixis’ business interests.
Equivalent combination of education and experience.
Deep knowledge and understanding of the drug development process and regulatory requirements and environment
Strong interpersonal skills and the ability to skillfully and appropriately manage, develop and mentor personnel in a matrix environment
Provide Regulatory assessment to due diligence teams in terms of risks, requirements, and opportunities associated with potential in-licensed assets
Bachelor’s degree in related discipline and a minimum of twenty-one years of related experience; or,
Regulatory Affairs Associate Jobs
By Select Source International At Alameda, CA, United States
Experience with global regulations and/or CE marking beneficial.
Relies on experience and judgment to plan and accomplish goals. Performs a variety of tasks.
Typically reports to a manager.
May lead and direct the work of others.
A wide degree of creativity and latitude is expected.
Job Title: Regulatory Affairs Associate
Summer Associate - Regulatory
By Rare Beauty At El Segundo, CA, United States
Strong time management skills with ability to effectively prioritize tasks
Updating internal project trackers and project management systems
Strong written and verbal communication skills
Assist with day-to-day regulatory operations (formula review, filings, formula testing, sample shipping, document organization, etc.)
Help collect formulas and documents from manufacturers to support the product safety and regulatory review process
Assist with international product registrations and global compliance reviews
Associate Director, Global Regulatory Sciences, Oncology
By Bristol Myers Squibb At San Diego, CA, United States
Ph.D., M.D., PharmD. , MS or commensurate experience
Significant experience in regulatory affairs (e.g. 3-5 years)
Direct experience in developing strategy and leading teams through interactions with FDA.
Extensive experience in initiating and conducting successful interactions within FDA.
Develop strategic direction and provide leadership for all regulatory interactions with FDA/global regulatory authorities
Provide strategic direction (and content input) on US Labeling
Global Regulatory Affairs Coordinator
By CooperVision At , San Ramon, Ca $62,285 - $83,046 a year
Interfaces with management and department.
Complies with management direction. Seeks assistance from supervisor in identifying and reporting problems or concerns relating to job functions.
Conducts self in a professional manner with colleagues, management, customers, and others. Models the corporate values.
Maintains contracts and invoice coordination with respect to Regulatory requirements.
No significant travel. Occasional requirements to attend offsite meetings.
Have attention to detail with organizational skills
Staff Software Regulatory Affairs Analyst (Remote)
By BD At , San Diego, 92130, Ca
Direct experience with Medical Device Software regulations IEC 62304 / 82304, IEC 60601.
5+ year's validated experience with regulated medical device development.
Validated understanding of QMS, demonstrating experience in supporting QMS process implementation using methodologies that promote compliant and agile software development practices.
Minimum of 5 years’ validated experience working with US 510(k)/PMA and CE Tech Files including software-driven medical devices and related products.
Knowledge of hardware-based device development, compliance testing, and documentation (i.e., traceability, integration, verification) a plus.
Certifications (RAC, CQA, CQM, etc.) preferred.
Sr Associate Regulatory Affairs - Cmc - (Open To Remote)
By Amgen At , Los Angeles, Ca $83,292 - $104,433 a year
Developed project management and organizational skills
Document and archive CMC submissions and related communications in the document management system
Regulatory CMC specific knowledge and experience
Lead the organization and preparation of the CMC sections of global annual notifications to meet regulatory requirements
Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development
Strong and effective oral and written communication skills
Regulatory Affairs Associate Jobs
By Intellectt Inc At Santa Clara, CA, United States
May require an advanced degree and 5-8 years of direct experience in the field.
Knowledge of FDA PMA guidance documents and CFR regulations.
Monitoring changing regulations (emerging regulatory issues, trends) in rest of the world geographies and translating regulatory requirements into the quality system.
Driving implementation of new international regulatory requirements, ensuring procedures are current and regulatory requirements and guidelines are met.
Review/approval of engineering study protocols/reports and validation study protocols/reports.
Review and approval of manufacturing changes for Class III implantable medical devices.
Counsel, Privacy & Regulatory Affairs
By TikTok At San Jose, CA, United States

Responsibilities Company Introduction TikTok is the leading destination for short-form mobile video. Our mission is to inspire creativity and bring joy. TikTok has global offices including Los ...

Head Of Regulatory Affairs
By Compass Life Sciences At San Francisco Bay Area, United States
8+ years of regulatory experience in the CRO, pharmaceutical, or biotech industry.
Experience working in a small biotech environment is highly preferred
Subject matter expert knowledge of US regulations
Bachelor’s or more advanced degree in a scientific discipline
You should be able to demonstrate the following;
+44 (0) 2394 311075, + (1) 98 444 9942
Regulatory Strategist, Global Regulatory Affairs
By Kite Pharma At , Santa Monica, Ca $94,690 - $122,540 a year
Good project management skills, as evidenced by ability to manage multiple assignments simultaneously without compromise to timelines or quality.
Knowledgeable with the drug development process, cell therapy industry, and Regulatory practices; eCTD submission experience highly preferred
Helps expedite and improve regulatory administrative activities by training and advising new or less experienced colleagues.
Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
Master’s and 2+ years of relevant experience OR
Bachelor’s and 4+ years of relevant experience OR
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)
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 Jobs
By Revlon At Edison, NJ, United States
Regulatory experience in the cosmetic industry, with a particular focus of EU fragrance allergens is a plus.
IT Skills (Microsoft Office, SAP, etc.)
Analytical skills and understanding technical scientific information
Strong written and oral communication skills are required. Strong interpersonal skills are important for working in fast-paced and matrix driven environment
Gathering, generating, and managing technical fragrance information
Provide Regulatory guidance, and support, including but not limited to:
Regulatory Affairs Associate Jobs
By Mindlance At Plymouth, MN, United States
Skills: Knowledge of US and/or Canadian regulation relating to product and/or device clearance
Communicates issues to management through project management tracking and issue briefings.
Minimum of 3 years’ experience
Ability to manage and track broad and strategic projects.
Responsible for effective communication of regulatory requirements to project teams and internal customers.
Position is highly visible to internal and external stakeholders.
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
Associate Director, Regulatory Affairs Cmc
By GSK At Collegeville, PA, United States
Project management experience with excellent interpersonal, presentation and communication skills.
Three or more years complex worldwide CMC regulatory strategies/requirements and demonstrated ability to influence the global internal/external regulatory environment. 
Two or more years of experience managing and directing multiple projects/teams in a high matrix environment.
One or more years of experience fulfilling a key role in major filing activities.
Experienced in supervising and training junior staff and the ability to motivate and lead others.
Managing the global CMC regulatory activities for multiple projects/teams simultaneously and respond readily to changing events and priorities.
Regulatory Affairs Associate Jobs
By eTeam At Deerfield, IL, United States
• Serves system administrator for the client's US Regulatory electronic document management system
Location: Deerfield IL Or 100% Remote
Job Title: Publishers (US Submissions)
Pay Range: $25.00/hr to $30.00/hr on W2
• He/she will serve as the primary publisher of US Regulatory submissions (Drug and Device)
Associate, Regulatory - Legal Us
By PIMCO At Austin, TX, United States
Able to generate solutions and appropriately escalate to management
Minimum 3 years of law firm / in-house paralegal or regulatory compliance experience
Financial product and/or securities law knowledge is a plus
Strong analytical skills and meticulous attention to detail
Able to take initiative in learning and applying new skills
Coordinate responses to various information requests, including 3rd party, client, and investor requests related to various legal / regulatory topics
Associate Regulatory Specialist Jobs
By Ecolab At St Paul, MN, United States
Support Free Trade Agreements program - perform qualifications for Free Trade and provide suggestions for cost savings opportunities
1 or more years of previous experience within Global Trade and/or Regulatory Affairs field
Good written and verbal communication skills
Experience with excel, VBA code, and SAP
Americans With Disabilities Act (ADA)
The ability to make an impact and shape your career with a company that is passionate about growth
Regulatory Associate Jobs
By Charter Research At The Villages, FL, United States
7. Report protocol deviations and serious adverse events to the IRB according to protocol and IRB requirements.
2. Exceptional planning/organizational skills and attention to detail.
3. Strong verbal and written communication skills.
1. 1 year of clinical research experience preferred.
1. Prepare regulatory documents for new study submissions to the IRB and sponsor.
Track the status of new submissions and inform clinical operations of relevant updates for study activation planning.
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
Regulatory Associate Jobs
By Pharmaron At Baltimore, MD, United States
2+ years of experience in a clinical research environment.
Perform initial and subsequent IRB submissions.
Create and maintain the Investigator Site File for all studies awarded to Pharmaron CPC.
Generate all essential documents (i.e., Form FDA 1572, Financial Disclosure Forms, etc.) for submission to sponsor.
Report deviations/violations and Serious Adverse Events to the IRB.
Ensure IND safety reports are submitted to the PI and IRB for review.
Regulatory Operations Associate Jobs
By Elsevier At Philadelphia, PA, United States
Provide training on eCTD publishing processes and requirements related to the preparation, publishing and life-cycle management of electronic submissions.
Providing Electronic Document Management System (EDMS) user support for team members.
Electronic Document Management System (EDMS)
Representing Reed Tech and address the client’s business requirements and needs.
Experience with DocuBridge and Veeva Vault RIM preferred.
Excellent Word and Adobe Acrobat skills required.
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.

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