Regulatory Support Job Description
Regulatory Support Duties & Responsibilities
To write an effective regulatory support job description, begin by listing detailed duties, responsibilities and expectations. We have included regulatory support job description templates that you can modify and use.
Sample responsibilities for this position include:
Regulatory Support Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Regulatory Support
List any licenses or certifications required by the position: ITIL, PMP, GMP, CAMS, COE, CCN, HWPD, VSF, VG, RSF
Education for Regulatory Support
Typically a job would require a certain level of education.
Employers hiring for the regulatory support job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Business, Finance, Science, Education, Accounting, Management, Engineering, Economics, Computer Science, Chemistry
Skills for Regulatory Support
Desired skills for regulatory support include:
Desired experience for regulatory support includes:
Regulatory Support Examples
Regulatory Support Job Description
- Registering and maintaining the records of our institutional clinical trials in clinicaltrials.gov
- Coordinating, managing, confirming, and documenting NCI registration for over 200 Investigators and Fellows
- Working with the Regulatory Affairs Managers to complete and process regulatory documents for submission to the Institutional Review Board (IRB), the Clinical Trials Review Committee (CTRC), and external sponsors
- Abstracting protocol and consent information for input into multiple regulatory documents and databases as required by various agencies (e.g., National Cancer Institute, FDA)
- Assisting Regulatory Affairs Managers with any aspect of protocol initiation and coordination
- Maintaining appropriate databases/spreadsheets to support regulatory activities, such as management of Data and Safety Monitoring minutes for over 900 trials
- Preparing regulatory binders for monitor visits by pharmaceutical representatives Coordinating and compiling materials for regulatory-related projects as needed (1572's, CV's
- Coordinating and maintaining an effective filing system of essential study documents
- Supporting the IND Manager in coordinating communications to the FDA and other agencies as required by the IND and study
- OAdverse Event Reporting, coordination of Safety Reports for reporting at weekly conferences
- Experience and strong product knowledge of Fixed Income products (3 to 5 years experience preferred)
- Auditing experience with a firm of auditors/accountants
- A high level of IT user ability, experience and skills, particularly Microsoft Excel
- Excellent communication and interpersonal skills to work within our team and across our business
- Team working skills and ability to deal with people at all levels
- The ability to work with initiative, managing workload effectively, meeting deadlines
Regulatory Support Job Description
- Work independently with minimal guidance on complex compliance assessment issues with critical impact to the organization
- Anticipate risk and compliance issues and develops innovative solutions to mitigate risks
- Develop and coordinate preparation of presentation materials for various levels of management
- Work with all levels of leadership across functions to influence decisions around compliance issues
- Work with senior management to support strategic planning and decision making on compliance issues
- Present findings and make recommendations to functional management, directors, officers and their employees
- Develop tools and templates for LOBs to assist in their compliance program activities
- Oversee various compliance initiatives, as appropriate
- Support others in the anticipation of risk and compliance issues and develop innovative solutions to mitigate risks
- Support the development and help coordinate preparation of presentation materials for various levels of management
- Prepare and manage deliverables and meeting materials for Session D activities, and support the process
- Support the development of tools and templates for LOBs to assist in their compliance program activities
- Provide subject-matter compliance support to LOBs
- Support various compliance initiatives, as appropriate
- Provide subject-matter expertise and compliance support to LOBs
- Assist all levels of leadership across functions to influence decisions around compliance issues
Regulatory Support Job Description
- Direct ownership of specific line functions - including lease accounting, fixed assets, and SOP 98 Internally Developed Software accounting
- Responsibility for formal attestation of related balances and controls
- Ownership for the risk & control processes for Corporate Support Finance - including SOX 404, RCSA, Business Continuity Planning and Monthly risk metrics reporting
- Ability to play a leadership role on key global projects and initiatives for Corporate Support Finance
- Develop strong partnership and liaise with peers in Finance such as Transfer Pricing, Legal Entity Controllers, Treasury, Tax and central Risk Management teams
- Provide Regulatory Compliance Leadership in the GRA-EMEA organization, with a strong focus on the local regulatory teams (LOC-RA, RMC) the EMEA TAs
- Provide strategic and tactical advice to the GRA-EMEA SLT in the field of Regulatory Compliance
- Ensure an adequate level of compliance in GRA-EMEA
- Ensure awareness of quality and regulatory requirements in GRA-EMEA
- Serve, as a CoE for the LOCs, RMC and TAs in the area of Regulatory Compliance, including support for audits and inspections
- 7+ years of experience with / strong GAAP, IFRS, and SOX experience
- Experience dealing with Regulatory issues
- 10+ years of relevant experience, with minimum of 5 years in an accounting focused role
- CPA and, preferably, Series 99 qualified
- Ability to both understand and drive process change but also empower and galvanize senior direct reports
- Act as a primary contact with and co-ordinate activities related to regulatory compliance and quality with other GRA-departments
Regulatory Support Job Description
- Provide leadership in driving continuous improvement in compliance level by reviewing CAPAs and self-assessment findings
- Develop and delivers (as needed) training and coaching
- Implement global compliance programs in the EMEA region
- Support PTR product managers in generating submission timelines
- Communicate with technical subject-matter experts to ensure that content is delivered according to schedule and to provide status updates
- Represent SMG in Technical Regulatory Teams and in Technical Development Teams, in cross-functional meetings, projects and initiatives, as needed
- Serve as a point of coordination and support to desks in Global Markets, IBCM, SUB and APAC
- Assist with running business-line regulatory reviews (eg
- Assist with tracking and remediation of regulatory data quality issues
- Perform recurring and ad-hoc data analysis using excel and present results in a concise, clear manner
- Excellent knowledge of the EU regulatory system, organization and procedures
- Strong interpersonal, communication, teamwork and negotiation skills
- 3-5 years of pharmaceutical experience in a global regulatory environment, including experience with document management technology and electronic publishing software
- Provide support with responses to regulatory queries
- Review exception reports periodically and flag key triggers to US Regulatory Services leadership
- Understanding of data flows, business processes, financial products and credit risk management
Regulatory Support Job Description
- Accountable for the implementation of IT projects and services required for the Safety, Medical & Regulatory business domain
- You will work with the ADA DevOps Team to perform statistical modeling related to gas load forecasts and ad hoc analyses
- Perform other tasks like broker account review, notification
- Well organize the schedules and meetings for Head of Compliance Risk and Regulatory Relations, PRC
- Organize schedules & meetings for Beijing Compliance team
- Support to follow up outstanding issues in relation to team management
- Support expense reimbursement
- Assist preparing materials for management presentation
- Inter-department & team communication and information collection
- Plan and execute all parts of Change Request management / UAT management and Enhancement Release Management
- Minimum BS in Chemistry, Engineering, Microbiology, or other technical field
- Demonstrated ability to problem solve and use scientific reasoning to provide solutions
- Individual must be self-motivated and be able to work independently while managing the program
- Ability to interact with multiple levels of management, various departments within the company external customers including regulators, market operators and other market participants is critical
- A Masters or PhD in Engineering, Economics, Mathematics or Computer Science is preferred
- 7 plus years’ experience in a pharmaceutical environment including not less than 4 years of experience with CMC regulatory related activities