Regulatory Associate Job Description
Regulatory associate
provides advice on regulatory requirements and compile and submit registration dossier for new product development and innovation and existing product registrations.
Regulatory Associate Duties & Responsibilities
To write an effective regulatory associate job description, begin by listing detailed duties, responsibilities and expectations. We have included regulatory associate job description templates that you can modify and use.
Sample responsibilities for this position include:
Publish regulatory documents for eCTD and similar submissions to the FDA, Health Canada, EMA and other health authorities
Preparation of US Federal Reserve regulatory reports
Reviews all responses to Requests for Proposals
Assist with the filing and management of documents in the document management system and Document Management Room
Participate in the validation of electronic systems
Assist in the conversion of paper files to electronic files
Participate, as requested, in team meetings and provide updates on the status of submissions
Maintain tracking of submission documents
Maintain up-to-date working knowledge of eCTD and paper submission requirements and provide that information to team members
Interact with and assist with the supervision of the eCTD vendor
Regulatory Associate Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Regulatory Associate
List any licenses or certifications required by the position: RAC, TSE/BSE, RS, RAPS, CCBCO, CRCM, CFA, ACRP, CIP, WIPP
Education for Regulatory Associate
Typically a job would require a certain level of education.
Employers hiring for the regulatory associate job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Science, Chemistry, Pharmacy, Engineering, Technical, Life Sciences, Biology, Education, Communication, Medical
Skills for Regulatory Associate
Desired skills for regulatory associate include:
Regulations pertaining to human subject protection
Regional and Global regulatory environment and how it impacts regulatory dossiers and registration
Submission processes and product life cycle management activities for various consumer product categories
NPD and dossier/technical file creation and global registrations
Federal
FDA
NCI
Institutional
OHRP
ICH GCPs
Desired experience for regulatory associate includes:
Complete documentation required by the eCTD vendor to facilitate publishing and submission activities
Prepare required regulatory submission forms
Perform quality control review of submissions
Support Regulatory Department team members in the completion of submissions and maintain regulatory documentation, both paper and electronic in format
Work with colleagues in resolving regulatory issues and/or problems
Archive and maintain all submissions in a systematic way
Regulatory Associate Examples
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Regulatory Associate Job Description
Job Description Example
Our innovative and growing company is hiring for a regulatory associate. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for regulatory associate
- Assisting stakeholders in preparing and updating performance indicator reporting to the Board
- Adding / maintaining procedures
- Acting as a liaison with other departmental stakeholders on hand-offs and analysis
- Support Volcker Metrics Reporting transferring from Legal to Regulatory Reporting
- Prepare and review regulatory workpapers to support filings
- Assist in the development, enhancement and maintenance of the regulatory control framework for daily, weekly, monthly, quarterly and annual reporting functions
- Assist with all aspects of the CM LLC & CMA FOCUS Report, Securities Haircuts, and other Capital Charges
- Proactively identify areas for improvement and automation to reduce operational risks and enhance the control environment
- Review and comply with Firm Policies applicable to your business activities and escalate operational risks and control deficiencies that you identify to your line manager
- Identifying, monitoring and analyzing regulatory developments, together with ongoing tracking of implementation status
Qualifications for regulatory associate
- University graduated with degree in Accounting and related subject
- Member of ICPA would be preferable
- Maintain the Material Risk Taker (MRT) identification and tracking databases, systems and operational processes including the maintenance of the MRT list
- Manage the MRT Allowance payment process across the region, working closely with HR Operations
- Contribute to matters relating to European regulators
- Highly numerate with advanced analytical and data presentation skills
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Regulatory Associate Job Description
Job Description Example
Our company is looking for a regulatory associate. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for regulatory associate
- Investigate regulatory history of similar products to assess approval implications
- Assist in monitoring and reporting project timelines
- Respond to regulatory information requests
- Monitor and utilize tracking and control systems
- Plays a lead role in staying current with the regulatory landscape as it pertains to a central lab
- Provide regulatory affairs consultative support, develop, and implement regulatory strategic plans
- Liaise with internal and external groups to collect necessary documents/information, and participate in the writing, review, and preparation of eCTD compliant submissions and regulatory filings related to Rx and OTC drugs (including biologics), cosmetics, medical devices, Natural Health Products and veterinary drugs, and associated amendments/supplements to Health Canada, EU, US, and other regulatory Agencies
- Review drug advertising and promotional material for US and Canada
- Recommend changes for labeling, manufacturing, and marketing for regulatory compliance
- Be responsible to initiate and manage regulatory affairs projects, within specified timeframes, ensuring accurate content, and quality control of each project
Qualifications for regulatory associate
- Regulatory reporting experience is beneficial, including experience with FR Y9C, Call Report
- Liquidity and regulatory reporting knowledge, including experience with LCR, FR Y9C, Call Report, FR Y-11, preferred
- Able to use relevant computer system applications (which may include spreadsheets, word Processors, databases, ) at an intermediate level
- Proactive towards regular job duties and procedural efficiency
- Experience with the Centers for Medicare and Medicaid Services Final Rule, 42 CFR Parts 447 and 455, for Medicaid Program
- Knowledge of equity trading practices and market structure issues gained at an investment dealer, regulator or marketplace
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Regulatory Associate Job Description
Job Description Example
Our innovative and growing company is looking for a regulatory associate. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for regulatory associate
- Create, update, and disseminate procedure(s) specific to the clients supported, and work with teams to ensure comprehension and follow through
- Serve as primary point of contact between the agency and the clients' MLR Review department, both to get information regarding submissions requirements and to answer procedural questions that arise during the MLR review process
- Consult, prepare and file investment adviser and broker-dealer applications with the Securities and Exchange Commission (SEC), FINRA and states
- May directly interact with regulatory agencies
- Understand the data model
- Integration/synchronization between in-house systems (MAESTRO, BDR and NCR)
- Business requirements provided to ITEC
- Contributing to building the regulatory strategy of OPER in the region
- Implementation of proper KPI’s in order to ensure a smooth hand-over of the improvements to the process owners
- Identification and definition of the specific problems related to the processes to be improved and controlled
Qualifications for regulatory associate
- Handle detailed tasks and prioritize them
- Think analytically and critically
- Review and analyze documentation
- Research and locate information on regulatory requirements and products
- Has general knowledge of technical alternatives and gain an understanding of their impact on the systems environment
- Apply business ethical standardsSearch Jobs US
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Regulatory Associate Job Description
Job Description Example
Our growing company is hiring for a regulatory associate. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for regulatory associate
- Responsible for acquiring, preparing and submitting information and data for reporting ZEV final MY submissions to state government agencies via the California Air Resource Board (CARB) - ZEV Credit Reporting and Data Tracking System (CRDTS)
- Manage Emission Related Parts Analysis to resolve High Priced Parts (HPP) for CA 7/70 Warranty
- Facilitate the process for developing, editing and/or introducing various forms of MBUSA service related literature including, but not limited to, Maintenance Sheets and Manuals, and the Warranty Booklets
- Assist in supporting the program for IACUC inspection of animal care and use facilities by participating in the facility inspection process
- Assist in supporting the program for IACUC review and approval during the life of animal use protocols by conducting administrative/regulatory reviews and facilitating resolution of questions/concerns by the IACUC with the principal investigators
- Develop and maintain good working business relationships with relevant government officials internal groups such as Legal, R&D, Marketing, Sales, and Customer Service
- Draft and edit multiple regulatory reports concurrently
- Work collaboratively with experts in other analytical disciplines to define integrated analytical solutions to problems
- Independently communicate problems with management and clients
- Clearly communicate technical information and project status to clients and internally through written and oral manner
Qualifications for regulatory associate
- Knowledge of and experience with United States food regulations
- Post-Marketing Commitments (PMCs) and Other Regulatory Commitments
- 4+ years of experience in the preparation of complex deliverables under tight deadline constraints
- Experience w/ Material & Device Master Files, regulatory documentation prep, submissions, filings
- 5+ years of Investment Adviser and/or Broker-Dealer Compliance experience
- Bachelor degree in life sciences desirable
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Regulatory Associate Job Description
Job Description Example
Our company is searching for experienced candidates for the position of regulatory associate. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for regulatory associate
- Execute and provide regulatory support and input
- Keep current with all relevant guidance
- Contribute to supporting a high quality and effective infrastructure to meet the regulatory requirements which support the launch of associated products
- Understand how the government operates and key touch points company can access to influence policy development
- Provide Regulatory Support for products and project
- Complete other duties as assigned by supervisor
- Execute US and international regulatory submissions to ensure timelines are met according to global strategic plans
- Support implementation of process and procedural improvements to drive efficiency within a growing digital health organization
- Review, draft, negotiate and process agreements and amendments in accordance with corporate guidelines
- Manage projects involving the collection and submission of data and information related to government audits, surveys and requests
Qualifications for regulatory associate
- Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area
- Relevant regulatory / clinical research document management experience in a pharmaceutical company/ CRO
- Must be strong in Microsoft Excel (Power User Level)
- Strong knowledge of various financial products (.i.e
- Certification in Clinical Research strongly preferred (CCRP, CCRC, CIP)
- Ensure that PRA regulatory outputs are produced on an accurate and timely basis in line with SLAs, including calculating and posting of all planned and ad hoc adjustments