Log In

Log In to Save

Sign Up to Save

Sign Up to Dismiss

or

The email and password you specified are invalid. Please, try again.

Email and password are mandatory

Forgot Password?

Don't have an account? Sign Up

reset password

Enter your email address and we will send you a link to reset your password.

Back to Log In

Become A Regulatory Affairs Associate

Where do you want to work?

To get started, tell us where you'd like to work.
Sorry, we can't find that. Please try a different city or state.

Working As A Regulatory Affairs Associate

  • Evaluating Information to Determine Compliance with Standards
  • Getting Information
  • Updating and Using Relevant Knowledge
  • Interacting With Computers
  • Communicating with Supervisors, Peers, or Subordinates
  • Mostly Sitting

  • $61,543

    Average Salary

What Does A Regulatory Affairs Associate Do At Abbvie

* Demonstrates ability to apply CMC, non-clinical and clinical understanding and disease state knowledge in a regulated environment.
* Identifies and communicates routine Health Authorities filing needs.
* Responsible (with manager’s oversight as needed) for educating internal customers on Regulatory issues including clinical development, non-clinical, Discovery, CMC, commercial, public affairs, legal and others who contribute to regulated communication or communications that could be regulated.
* Serve as the Regulatory Affairs representative on key sub-teams
* Maintains thorough knowledge of product data and key product issues across multiple programs.
* Prepares routine submissions in compliance with department and regulatory requirements and guidelines.
* Assists with larger or more complex submissions.
* Functions independently in decision making for routine issues.
* In conjunction with manager, reviews complex issues and problem resolution successes and setbacks to assist in future problem solving applications/options.
* Completes tasks and disseminates pertinent information to appropriate inter-departmental areas.
* Serves as department representative on cross-functional initiatives Responsible for supporting the department, division and company’s strategic direction and goals
* With management guidance participates in the problem solving process by monitoring issues and implementing strategies for resolution.
* Analyzes and interprets information, impacting regulatory decisions
* Consistently exercises good judgment in the application of policies and regulations.
* Works well with other individuals and departments in solving problems

What Does A Regulatory Affairs Associate Do At Kelly Services

* Maintain quality and regulatory document files.
* Gather necessary paperwork and documentation for regulatory filings.
* Create and maintain database of quality & regulatory documents.
* Assist with the annual registration of client's sites with the US FDA.
* Prepare correspondence for regulatory agencies.
* Compile and track changes and oversee regulatory requirements (regulations, guidelines, standards, USP, EP,...) pertaining to the client's products for pharma, food and medical device
* applications.
* Maintain Drug Master File for technical documents.
* Interact with regulatory personnel in different countries.
* Work in an interdisciplinary, intercultural environment

What Does A Regulatory Affairs Associate Do At System One Services

* Plans, coordinates and writes responses to inquiries from the FDA resulting from their review of the submissions.
* Submissions will include: ANDAs, Amendments, Supplements, Annual Reports, 505(b)(2) and 505(b)(1) files
* Reviews technical documents for accuracy and acceptability
* Independently authors, complies and reviews ANDAs, NDAs, Amendments, Supplements and Annual Reports.
* Reviews and signs-off on change control documentation.
* Translates and communicates regulatory requirements and strategies to team members and to internal/external business units

What Does A Regulatory Affairs Associate Do At Fresenius Medical Care North America

* Developing professional expertise; applies company policies and procedures to assist in the day-to-day procedures used to support regulatory submission (drugs and device) and publishing activities.
* Assists in the maintenance of an archiving/document management system.
* Responsible for producing and tracking FMCNA regulatory submissions and submissions-compliant documents in the electronic format (eCTD and eFiling).
* Responsible for assisting in implementing and maintaining various departmental guidelines, procedures and templates associated with the regulatory document management system, regulatory information system, and electronic submissions.
* Works with department and external groups as assigned.
* Participates in the evaluation and provide input for new department technologies and collaborate with intra-departmental resources to ensure adherence to infrastructure standards.
* Compiles, publishes, QC, and validates documents for FDA submission.
* Troubleshoots document issues in MS Word and Adobe Acrobat.
* Provides editing and formatting support.
* Supports the transition from legacy to electronic submissions.
* Coordinates with regulatory staff to compile regulatory submissions.
* Ensures that all required documents are received and formatted appropriately and in a timely manner.
* Demonstrates knowledge of electronic submission requirements and prepares for future initiatives and requirements.
* Participates in a document management system to align document access and storage with RA electronic submission needs.
* Assists in development of overall project timing.
* Works on problems of moderate scope where analysis of situation or data requires a review of a variety of factors.
* Exercises judgment within defined procedures and practices to determine appropriate action.
* Builds productive working relationships.
* Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
* Assists with various projects as assigned by direct supervisor.
* Other duties as assigned

What Does A Regulatory Affairs Associate Do At PPD

* Provides regulatory consulting and strategic advice to internal and external clients
* Provides project specific GRA strategy, technical expertise and co-ordination oversight for key client’s projects
* Liaises with PPD globally to support global projects, and ensures quality performance for key/managed projects
* Serve as key clients “Executive” contact person for all issues including attendance at Regulatory Authority meetings and other Public Relation functions
* Manages project budgeting/forecasting
* Assists business development and senior management in pricing and securing new business by making presentations to clients, developing and reviewing bid proposal texts and budgets and conducting contract negotiation through to closure
* Contributes to development & implementation of Global/regional function/plans
* LI-SH1

Show More

Show Less

Regulatory Affairs Associate jobs

Add To My Jobs
Job type you want
Full Time
Part Time
Internship
Temporary

Real Regulatory Affairs Associate Salaries

Job Title Company Location Start Date Salary
Regulatory Affairs Therapeutic Area Associate Director Novartis Institutes for Biomedical Research, Inc. Cambridge, MA Mar 08, 2016 $140,000
Principal Regulatory Affairs Associate-Pharma Fresenius USA Marketing, Inc., A Fresenius Medical Care Na Company Waltham, MA Jan 10, 2016 $127,502
Senior Regulatory Affairs Associate Thoratec Corporation Pleasanton, CA Sep 14, 2015 $112,000 -
$123,600
Regulatory Affairs Associate II Devices Fresenius USA Marketing, Inc., A Fresenius Medical Care Na Company Waltham, MA Apr 01, 2016 $105,000
Global Regulatory Affairs Associate, Senior Genzyme Corporation Cambridge, MA Jul 25, 2016 $101,067 -
$102,566
Regulatory Affairs Associate II Fresenius USA Marketing, Inc., A Fresenius Medical Care Na Company Waltham, MA Aug 10, 2015 $100,000
Regulatory Affairs Publishing Associate Vividstarts LLC Cambridge, MA May 16, 2016 $100,000
Regulatory Affairs Associate Principal Genzyme Corporation Cambridge, MA Jul 09, 2016 $98,924 -
$148,386
SR. Regulatory Affairs Associate Gilead Sciences, Inc. Seattle, WA Sep 10, 2015 $97,000
Senior Regulatory Affairs Associate Stealth Biotherapeutics Inc. Newton, MA Aug 31, 2015 $92,000 -
$102,000
Regulatory Affairs Associate III Anchen Pharmaceuticals, Inc. Irvine, CA Dec 17, 2015 $91,354 -
$110,000
Regulatory Affairs Associate Edwards Lifesciences LLC Irvine, CA May 07, 2016 $91,354
Regulatory Affairs Associate Bonita Pharmaceuticals, LLC Westland, MI Jan 08, 2016 $90,000
Regulatory Affairs Associate Alvogen, Inc. Brookfield, NJ Feb 29, 2016 $78,000
Regulatory Affairs Associate II Amneal Pharmaceuticals LLC Piscataway, NJ Mar 10, 2016 $78,000
Senior Regulatory Affairs Associate DR. Reddy's Laboratories, Inc. Princeton, NJ Jan 10, 2016 $78,000
Senior Regulatory Affairs Associate Lannett Company, Inc. Philadelphia, PA Oct 23, 2015 $77,210
Regulatory Affairs Associate TEVA Pharmaceuticals USA, Inc. Parsippany-Troy Hills, NJ Jun 12, 2016 $76,000
Senior Regulatory Affairs Associate Lupin Pharmaceuticals, Inc. Baltimore, MD Feb 12, 2016 $75,863
Associate 2, Regulatory Affairs International Biomarin Pharmaceutical, Inc. San Rafael, CA Aug 26, 2015 $75,000
Regulatory Affairs Associate Alkermes, Inc. Waltham, MA Jan 25, 2016 $75,000 -
$85,000
Regulatory Affairs Associates Novel Laboratories, Inc. Somerset, NJ Jan 10, 2015 $62,000
Senior QA Regulatory Affairs Associate Dxterity Diagnostics Inc. East Rancho Dominguez, CA Sep 23, 2015 $62,000 -
$70,000
Regulatory Associate III Amneal Pharmaceuticals LLC Piscataway, NJ Sep 07, 2015 $62,000
Regulatory Associate II Amneal Pharmaceuticals LLC Piscataway, NJ Sep 14, 2015 $62,000
SR. Regulatory Affairs Associate Novel Laboratories, Inc. Somerset, NJ Aug 26, 2016 $61,693 -
$71,000
SR. Regulatory Affairs Associate Amneal Pharmaceuticals of Ny, LLC Hauppauge, NY May 01, 2016 $61,069
Senior Regulatory Affairs Associate Amneal Pharmaceuticals LLC Piscataway, NJ Feb 09, 2015 $61,053
Regulatory Affair Associate Global Pharma TEK LLC Sunrise, FL Sep 22, 2015 $60,000

No Results

To get more results, try adjusting your search by changing your filters.

Show More

Top Skills for A Regulatory Affairs Associate

FDARegulatoryComplianceNDARegulatoryAffairsMedicalDevicesAnnualReportsINDProceduresRegulatoryDocumentsDataEntrySafetyReportsRegulatorySubmissionsCMCRegulatoryStrategyRegulatoryRequirementsClinicalTrialProtocolAmendmentsEnsureComplianceRegulatoryAgenciesInvestigatorBrochures

Show More

Top Regulatory Affairs Associate Skills

  1. FDA
  2. Regulatory Compliance
  3. NDA
You can check out examples of real life uses of top skills on resumes here:
  • Assisted in the preparation and submission of abbreviated new drug applications and annual reports to FDA.
  • Created and reviewed Standard Operating Procedures for the department to ensure Regulatory Compliance.
  • Review incoming proposals, research organizations, assist in recommendations for funding and communicate fund disposition to organizations.
  • Assist in managing regulatory complaints and regulatory affairs databases.
  • Prepare documentation for medical devices and OTC product registration.

Top Regulatory Affairs Associate Employers

Regulatory Affairs Associate Videos

Designing Your Career as a Regulatory Professional

Career Pathways: Breaking into the Business of Regulatory Affairs & Biotechnology

4.2 Regulatory Affairs Basics - Medical Devices

×