Regulatory Advisor Job Description
Regulatory Advisor Duties & Responsibilities
To write an effective regulatory advisor job description, begin by listing detailed duties, responsibilities and expectations. We have included regulatory advisor job description templates that you can modify and use.
Sample responsibilities for this position include:
Regulatory Advisor Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Regulatory Advisor
List any licenses or certifications required by the position: RAC, CIPP, CRCM, PMP, CFA, FRM, KGMP, ISO, EU, US
Education for Regulatory Advisor
Typically a job would require a certain level of education.
Employers hiring for the regulatory advisor job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and University Degree in Engineering, Business, Science, Finance, Education, Economics, Accounting, Law, Technical, Public Policy
Skills for Regulatory Advisor
Desired skills for regulatory advisor include:
Desired experience for regulatory advisor includes:
Regulatory Advisor Examples
Regulatory Advisor Job Description
- Actively participate in the implementation of new regulatory account requirements and assess the impact to the Utility’s current regulatory reporting procedures
- Support business development proposals when required
- Serve as the primary representative of the San Francisco office to internal stakeholders on your portfolio of issues and lead and coordinate the development of communication materials from those teams for use externally
- Provide coaching and mentoring to Regulatory Affairs staff and internal case team members
- Maintain contact with inter- and intra-department personnel, managers and directors
- Conduct tier 2 and 3 (Subject Matter Expert) support of analytical products
- Providing guidance and support on the Investigators questions and concerns, providing advice as required day to day support
- The development of robust processes for monitoring, logging and ensuring closure of all regulatory requirements giving a high degree of confidence in our ability to comply with regulatory requirements across the business
- Successful management of information, advice, guidance and training across the business which address regulatory concerns and queries and ensure a cycle of continuous improvement
- Regular reporting of monitoring and analyses to relevant departments, with the aim of improving products and services and delivering a high degree of compliance in business processes and practices
- Be an authority on the European Regulatory Framework of human and veterinary medicinal products including keeping up to date with relevant legislation and regulatory guidance and sharing same with colleagues
- Must have excellent written/oral communication skills
- 6+ years of Western Canada oil and gas regulatory experience
- 6+ years of revenue regulatory experience preferred
- Revenue audit or ONRR experience preferred
- Advanced knowledge of professional accounting principles, theories, concepts and terms
Regulatory Advisor Job Description
- Professional, customer focused services and effective representation of the team and division
- Manage a high volume of member calls and emails on a daily basis in a fast paced work environment
- Ensure the outcome of negotiations with key clients are appropriately documented and incorporated into project documentation to enable effective project delivery
- Support novation of contracts or development of shadow contracts to CATO
- Provide advice and support to the wider project team in relation to the legal and regulatory issues
- Prepare regulatory assessments and plans for new products and design changes
- Prepare or direct the preparation of regulatory submissions for product approval/clearance, including 510(k) premarket notifications
- Support Investigational Device Exemption submissions
- Participate on product development Core Teams assisting with regulatory assessments and planning
- Review labeling, training, and promotional materials for compliance with claims and applicable regulations
- At least 5 years experience of human medicinal product regulatory affairs in the Pharmaceutical Industry
- Medical writing (clinical writing) experience essential
- Review, assessment and critique of clinical documentation
- Advanced knowledge of spreadsheets, database software and the automated accounting system used in the department
- Advanced knowledge of current Federal and State regulations
- Knowledge in working with SAP
Regulatory Advisor Job Description
- Support US and international product registrations
- Support post-market regulatory compliance activities for US and international products
- Preparation, QC and submission of national dossiers and licence maintenance applications to the local Health Authority (HPRA)
- Facilitate approval of new product licences, indications and dosage strengths for the Irish market
- Support the regulatory activities relating to product launches
- Maintain compliance of existing assigned Product Licences with European and national legislation
- Maintain local RA databases and Global compliance tracking systems to record local licence information (new indications, changes in indications, changes in product specifications, changes in licensing, new products and progress with development of new products)
- Review and update all product labels and leaflets for consistency with the licence for implementation according to required timelines
- Foster good relations with the HPRA
- Assist in the review of promotional material for consistency with the licence
- Ideal candidates would have experience with quality data (core measures and The Joint Commission) and the electronic transmission od data using hospital EHR systems
- Mutual fund regulatory and compliance (i.e., SEC filings, prospectus drafting and filing, preparing Board materials, attending Board meetings, portfolio compliance)
- To be the main point of contact in providing advice and guidance on specific areas of regulation
- 3-5 years healthcare consulting, healthcare quality data/informatics, operations management or patient-facing role or healthcare software implementation/account management (EPIC, Cerner, McKesson, ) experience
- Advanced knowledge of current Federal and State royalty regulations
- Experience with drafting, implementing
Regulatory Advisor Job Description
- Acts as a Subject Matter Expert on the rules associated with wholesale generation and transmission interconnections
- Reviews proposed rules/regulations, identifies key issues, summarizes for management
- Prepare and update Abbreviated Prescribing Information to be used in promotional material
- Providing support to Group Regulatory Advisory (GRA) team members focused on related financial stability topics, such as shadow banking, resolution and total loss-absorbing capacity
- To assist with regulatory submissions to US authorities (EPA, FDA etc) supporting business manufacturing, sales and marketing activities
- To keep abreast of relevant, new and emerging regulations and legislation relating to Americas chemicals management
- Maintain the Corporate Strategic Database (CSD) to ensure the accuracy of processing of the gas revenues for regulatory accounting purposes
- Serve as a witness or provide support to the designated witness in regulatory proceedings before the California Public Utilities Commission (CPUC) and the Federal Energy Regulatory Commission (FERC)
- Manage complex regulatory balancing and memo accounts including analyzing and preparing appropriate monthly entries and reviewing monthly revenue and expenses with subject experts while adhering to authorized tariff language and CPUC decisions and settlements
- Provide support in the development of regulatory account forecasts for the Utility’s calendarized and 5-year financial plan
- Understanding of the high tech industry or financial services highly desirable
- 10 years of regulatory affairs/legal or other relevant experience
- Strong Microsoft office (specifically Excel and PowerPoint) experience
- Ability to build relationships by communicating, influencing and negotiating effectively with senior stakeholders, project teams and technical experts across a global scenario
- Experience in acting as a liaison to and communicating with regulatory agencies
- Strong working knowledge of FDA medical device regulatory requirements
Regulatory Advisor Job Description
- Perform an overall review and margin reconciliation of the monthly regulatory account adjustments prepared by the Regulatory Account Group and Utility Accounting to ensure accuracy and regulatory compliance
- Prepare monthly revenue accrual and validation of monthly billed revenue for processing in CSD
- Provide support to the System Operator in the accounting for purchases and sales of gas for system reliability purposes and storage load balancing
- Inform RA and Financial Planning of any unusual adjustments to the Utility’s regulatory accounts which may significantly impact shareholder earnings in a timely manner
- Be able to read, interpret, and clearly explain complicated documents, including complex legislation and regulations
- Lead industry forum discussions and task groups (as directed) at the National Council for Prescription Drug Programs (NCPDP), PCMA, other trade associations, and CMS held conferences to shape guidance and resolve issues with industry partners
- Coordinate label development, approval, and release to production for all current and new products globally
- Advise production regarding inventory control and ensure an audit process to confirm label changes are implemented on a timely basis
- Research and advise on new requirements for entering new markets
- Interpret regulatory requirements, provide input into regulatory strategic planning, meet timelines for new product launches, and ensure that regulatory requirements are met in support of existing commercial products within Health Canada and US FDA jurisdictions
- Pharmacy primary degree, B.Sc
- RAC certification is a plus
- Bachelor's degree in environmental science, energy/environmental policy, environmental engineering or related field
- Minimum of seven (7+) years government experience
- Understanding of the business areas of investment banking, corporate banking, trade finance, and risk profile of each category
- Fluency in English as a business language