Regulatory Consultant Job Description
Regulatory consultant
provides senior management with data and analysis for business and regulatory reviews, strategic initiatives and new processes.
Regulatory Consultant Duties & Responsibilities
To write an effective regulatory consultant job description, begin by listing detailed duties, responsibilities and expectations. We have included regulatory consultant job description templates that you can modify and use.
Sample responsibilities for this position include:
Work with business lines to ensure that responses to customer complaints are well written, handled efficiently and account for risks
Identify and communicate issues and work with business line partners and other risk management professionals to support remediation efforts
Ensure compliance with standards for response drafting, timeliness, recordation and reporting
Remain current on regulatory and legal changes impacting bank products and services
Support a variety of other compliance projects and initiatives on an as-needed basis
The role will also have responsibility to author and manage the submission of clinical trial applications (INDs, IMPDs, CTAs), briefing documents, as they relate to CMC
Plan, manage, author and submit CMC content for clinical trial applications, amendments
Develop BOH communication materials as required, BOH meeting briefing documents, scientific advice requests
Design and delivery of regulatory training tailored to meet client's needs
Testing strategy (QSARs, in vitro, in vivo testing
Regulatory Consultant Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Regulatory Consultant
List any licenses or certifications required by the position: PMP, CRCM, CAMS, CFE, CPA, NSQIP, ACS, CCBCO, CISM, CISA
Education for Regulatory Consultant
Typically a job would require a certain level of education.
Employers hiring for the regulatory consultant job most commonly would prefer for their future employee to have a relevant degree such as University and Collage Degree in Business, Accounting, Finance, Economics, Engineering, Geoscience, Mathematics, Education, Law, Law School
Skills for Regulatory Consultant
Desired skills for regulatory consultant include:
Techniques for handling complaints and dealing with the public
Data and content
Drug development processes and regulatory submissions
Financial and statistical analysis and interpretation
Functions and drivers
Impact analysis and quantitative/data modeling methods
Medical Device and Diagnostics regulatory processes
440.05
Desired experience for regulatory consultant includes:
A minimum of a Bachelor's degree or equivalent qualifications in Biotechnology, Molecular Biology, immunology, Pharmacy or a related life science field.or a related life science field
Excellent scientific / technical knowledge of Biotechnology derived medicinal products
A minimum of 3 years experience in the pharmaceutical or related industry in CMC Regulatory Affairs
Good knowledge/background of the Drug Development process and regulatory process that apply to development products
Basic computer skills and relevant software packages
Interaction with many different departments within the company
Regulatory Consultant Examples
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Regulatory Consultant Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of regulatory consultant. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for regulatory consultant
- Manage complaints (from members and Regulators)
- Review Marketing material for compliance
- Manage various areas of Reporting
- Track and analyze new regulatory requirements pertaining to commercial lines of business
- GRAS determinations, relevant protocols, reports, general correspondence, and responses to US regulatory authorities
- Provides client program and/or portfolio oversight and senior level regulatory review/editing for NDA/BLA CTD Module 2 biopharmaceutics, clinical pharmacology and clinical efficacy and safety summaries and Module 5 CSR/ISE/ISS key messaging
- Expertly facilitates client and regulatory agency interfaces
- Provides leadership and oversight to a small clinical regulatory team
- Plays an active role in business development to expand portfolio of standalone regulatory and cross functional consulting projects
- Develops and executes on thought leadership strategy related to European regulatory advising
Qualifications for regulatory consultant
- Proficiency with FINRA rules and regulations
- Detailed understanding of asset management products, business and processes
- Proven attention to detail, with experience of documenting results and conclusions
- Analytical and communication skills required to review laws/regulations, and assess their impact
- Some experience interacting with regulators, and auditors
- Ability to negotiate, influence and collaborate with others in the assessment of compliance risks within NTAM
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Regulatory Consultant Job Description
Job Description Example
Our company is looking to fill the role of regulatory consultant. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for regulatory consultant
- To prepare and coordinate of regulatory deliverables for assigned projects in the Czech Republic and other countries, including close cooperation with regulatory authorities
- Communications lead for the department, with accountability for weekly status reporting, department web pages, and program team communications
- Works with department leads to create Steering Committee participants for each program, and works to maximize efficiency across programs and centralize / combine updates to particular executive audiences where appropriate
- Prepares more complex regulatory filings including the disclosure for prospectuses, Statements of Additional Information (SAIs), and supplements (“stickers”)
- Leads the process for maintaining, updating and organizing mutual fund registration documents and all exhibits, including routine and non-routine contracts
- Researches, evaluates and reports on regulatory matters related to mutual fund registration documents and fund financial statements
- Prepares SEC filings of funds and adviser and coordinates the EDGAR filing process for all fund SEC filings
- Serves as a resource and consults with internal/external stakeholders on a broad variety of matters related to SEC-registered investment funds and the Annual Update with the SEC of the registration statement for the funds
- Facilitates execution of routine quarterly and annual process for SEC filings
- Serves as primary technical expert and liaison with fund’s financial printer and prospectus system
Qualifications for regulatory consultant
- 5+ recent experience in Human Resources, Compliance or HRIS
- Experience working with Applicant Tracking Systems, HRIS Applications, EEO Reporting Applications preferred
- Prefer JD degree from an accredited university
- Prior bank or credit union industry experience a plus
- Ability to successfully perform fieldwork for bank compliance engagements
- Ability to travel nationwide up to 75% of the time
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Regulatory Consultant Job Description
Job Description Example
Our company is searching for experienced candidates for the position of regulatory consultant. 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 consultant
- Collaborates with appropriate stakeholder to ensure compliance in tracking new laws, regulations and industry developments and communicates developments and new procedures to internal stakeholders
- Prepares board materials for quarterly fund and adviser board meetings
- Analyzes trends for assigned area(s) or responsibility, assess the impact, and collaborates with management to incorporate new trends and developments in current and future solutions
- Manages, conducts and/or participates in more complex projects for his/her assigned area(s)
- Provides effective and open communication with internal/external stakeholders to ensure transparency and consistency of regulatory filings
- Prepares, updates and/or files more complex applicable reports, forms, and/or contracts for his/her assigned area(s) of responsibility
- Produce organized work papers
- Lead life sciences customers in the rapid configuration and implementation of software to support regulatory affairs and regulatory operations content and data in the form of the Vault RIM suite (Vault Registrations, Vault Submissions, Vault SubmissionsArchive)
- Define strategies and implementation program(s) for deploying Vault RIM across an organization globally
- Content management/registration data solution design, prototyping, configuration and documentation
Qualifications for regulatory consultant
- Bachelors degree with a concentration in Chemistry, Biology, Environmental Science, or related sciences
- Bachelor’s degree in Accounting, Finance, or Business with 7 years of related experience
- 5 years or more experience of adult learning in a corporate setting
- Minimum of 5 years hands-on multi-line claims administration experience with specific experience in Property & Casualty Insurance, Health Insurance and/or Business Interruption
- Advanced knowledge and attention to detail in insurance coverage and contracts, investigating mid- level to severe claims, setting timely and accurate reserves
- Advanced degree (PhD, PharmD, MD or MS) required
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Regulatory Consultant Job Description
Job Description Example
Our company is looking to fill the role of regulatory consultant. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for regulatory consultant
- Participate in projects at life sciences R&D companies
- Rapidly configure and implement the Vault RIM suite (Vault Registrations, Vault Submissions, Vault Submissions Archive) which is used to manage regulatory affairs and regulatory operations content and data in the cloud
- Lead requirements workshops, design, prototype, configure and document content management/registration data solutions
- Undertaking policy research, analysis and evaluation
- An ability to develop and convey expertise on a topic
- An ability to think through the methodological challenges of approaching a topic
- A good grasp of the strengths and weaknesses of various qualitative and/or quantitative methods
- A good understanding of regulatory policy at national and EU level
- A degree / higher degree, typically (but not exclusively) in political science, public administration, sociology, economics
- An ability to write quickly and to communicate with others in excellent English (additional European languages would be an asset)
Qualifications for regulatory consultant
- BSc in Life Sciences, advanced degree is an asset
- Candidates with a CRCM certification strongly preferred
- CAMS / CIA / CFE certifications also highly desired
- Minimum seven years of progressive experience in regulatory compliance within the banking industry
- Bachelor's degree in Business or a combination of education and experience providing equivalent knowledge
- Five years experience in fleet administration
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Regulatory Consultant Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of regulatory consultant. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for regulatory consultant
- Previous experience of working on environment or food related topics would be an asset
- Previous experience of bid writing (consultancy proposals or research grant applications), managing budgets, tasks, or client interactions would be an asset
- Actively participate in the development, implementation, and maintenance of the operational compliance program within OptumCare Claims in order to ensure that we are meeting company guidelines and regulatory
- Researches report requirements, prepares documents and tracks regulatory reporting compliance information and report submissions
- Assesses and evaluates progress to meet reporting deadlines
- Consults with oversight agencies on issues of non-compliance
- Facilitates resolution of non-compliance with internal associates
- Reports issues of non-compliance to management
- Ensures business unit complies with legislative and regulatory requirements for assigned states
- Maintains working knowledge of laws and regulations which affect reporting in assigned states
Qualifications for regulatory consultant
- Extensive knowledge of DOT, federal, state and local laws pertaining to fleet operations
- 2+ years of financial institution experience, including credit review, consumer lending, personal banking and/or credit administration experience is required
- Bachelor’s degree in Finance, Accounting, or related business field is preferred
- Prior bank industry experience and/or bank regulatory experience and knowledge of controls and processes are preferred
- Ability to travel an average 25-35% annually is required
- 3 - 5+ Years’ experience with mutual funds, investment advisers and/or service providers to mutual funds that directly aligns with the specific responsibilities for this position