Regulatory Affairs Director jobs in South Dakota
Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
Recently Added Regulatory Affairs Director jobs
Director, Quality & Regulatory
- Medvantx
-
Sioux Falls, SD
FULL_TIME
-
Job Summary/Objective
The Director, Quality & Regulatory, is responsible for assuring that the highest quality standards are met & maintaining a strong quality and regulatory adherent culture; monitoring and reporting on compliance results; providing guidance on matters relating to quality in all lines of business; and ensuring that all Medvantx adherence parameters to policies and procedures are in place Medvantx employees to comply with the quality rules and regulations of federal and state regulatory agencies. The Director, Quality & Regulatory is responsible for ensuring the implementation of quality assurance operating procedures, ensuring the completion of quality assurance/quality improvement assessments monthly, and monitoring quality improvement/quality assurance outcomes. The Director of Quality & Regulatory reports directly to the VP, Medical Affairs.
Key Responsibilities- Coordinate with commercial, operations, pharmacy, supply chain, legal, IT and other teams to ensure that compliance processes for various functions (such as item setup, pricing, logistics, online catalog and content and other eCommerce services) address legal and compliance requirements, including requirements from certain agencies (such as FDA, FCC, FTC, EPA, local State AGs, Accreditation bodies, etc.)
- Coordinate and lead the activities of the Medication Safety Committee and subcommittees, including monitoring and analyzing adverse drug events (ADEs)
- Prioritize and review best practice guidelines & quarterly action agendas, conduct gap analyses, and develop action plans as needed for relevant areas
- Review investigations and conduct CAPAs in adherence with pharmaceutical manufacturer requirements
- Lead root cause analysis and other performance improvement methods to enhance patient safety
- Monitor medication safety benchmarks and proactively assess risks across the medication use & fulfillment process
- Stay informed about current trends and developments in medication safety through ongoing education
- Maximize efficiency of risk assessments in a constantly evolving environment
- Develop and maintain standard operating procedures in adherence with local and federal regulatory requirements
- Create and monitor quality & regulatory KPIs to identify potential program risk; define long-term goals to help bolster trust among clients, partners, and customers.
- Interface with external quality, compliance, and audit teams at partnering organizations.
- Strives for uniformity throughout policies and procedures, written communication, and forms
- Participate in the tracking, preparation and submitting of federal, state, and local required forms and information to comply with accreditation bodies, licensing bodies, and other governing standard bodies to meet requirements, and ensure that all filings are accurate and timely
- Continuously seek, learn, and apply knowledge regarding governance and associated rules, regulations, best practices, tools, techniques, and performance standards
- Review audits and ongoing monitoring of DEA compliance, FDA compliance, PDMP compliance, OSHA compliance, HIPAA and HITECH compliance, and Boards of Pharmacy regulatory compliance, and compliance with client KPIs
- Partner with the CCO to the design and maintenance of quality programs, including but not limited to QA plans, inspection procedures, work instructions, training, deviation investigations and CAPA management, facility mapping and validation projects
- Follows, and provides leadership for, compliance with federal and state laws and rules; exercises due diligence to prevent, detect, and report unlawful and/or unethical conduct
- Ensures compliance within all external partners and vendors regulatory requirements
- Provides independent review and evaluation to ensure that compliance issues/concerns within the organization are being appropriately evaluated, investigated, and resolved. Collaborates with other departments (e.g., Risk Management, Finance, Human Resources, etc.) to address compliance issues (e.g., investigation and resolution). Consults with the corporate attorney as needed to resolve difficult legal quality & regulatory issues
- Identifies potential areas of vulnerability and risk; develops/implements corrective action plans for resolution of problematic issues and provides general guidance on how to avoid or deal with similar situations in the future
- Provides reports on a regular basis, and as directed or requested, to keep the Medication Safety Committee, the Executive Team, and the Board of Directors informed of the operation and progress of compliance efforts
- Ensures proper reporting of violations or potential violations to duly authorized enforcement agencies as appropriate and/or needed
- Lead change review process and oversee ownership related to implementation of new processes and technology
- Serve as the Medvantx liaison to the Governance Committee of the Board
- Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice
- Proven quality, compliance, and audit experience
- Curious about existing processes and confident enough to implement improvements
- Advanced computer skills in MS Office, accounting software and databases
- Ability to manipulate large amounts of data and to compile detailed reports
- Proven knowledge of auditing standards and procedures, laws, rules, and regulations
- High attention to detail and excellent analytical skills
- Sound independent judgement
- Bachelor’s Degree or higher in Public Health, Human Services or related field required
- Advanced professional degree (i.e. PharmD, PhD., JD, etc.) preferred
- Two (2) years of recent leadership or progressive supervisory experience required
- Prior experience supervising and managing Quality Assurance/Improvement staff
- 5 years of experience with pharmacy quality & regulatory
- 5 years of experience within biopharma, pharmacy quality health system, or other pharmacy related background preferred
- 3 years progressively responsible experience conducting or managing one or more of the following: Investigations, CAPAs, FDA 21 CFR, audits, examinations, or program reviews
- Extensive knowledge and ability to contribute in the areas of professional quality standards, data privacy, data integrity and data governance
- Strong and effective verbal and written communication skills with the ability to customize the approach for a variety of audiences
- The physical demands of this position are in keeping with general office functions: sitting, using a computer, keyboard, telephone, etc
- Reasonable accommodations can be made to enable employee to perform the essential job duties. (include in every job description)
- Preference for location in Louisville, KY or Sioux Falls, SD. Open to remote candidates on a case-by-case basis
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viAstdH1YO - 2 Days Ago
Director of Legal Affairs & General Counsel
- Great Plains Tribal Leaders Health Board
-
Rapid, SD
FULL_TIME
- Job SummaryThe General Counsel provides senior management with effective legal advice based upon attorney-client privilege and attorney work product doctrine on company strategies and their implementa...
- 10 Days Ago
Food Service Worker
- U.S. Department of Veterans Affairs
-
Hot Springs, SD
FULL_TIME
- Starting Hourly Wage $ 16.85This is a Temporary Not to Exceed (NTE) 1-year position.The Veterans Canteen Service (VCS) located at the Hot Springs, SD, VA Medical Center is seeking part-time Food Servi...
- 2 Days Ago
Food Service Worker
- U.S. Department of Veterans Affairs
-
Fort Meade, SD
FULL_TIME
- SummaryWage Grade 2 Food Service Workers at the Fort Meade VA perform tasks with several steps or a sequence of tasks that requires attention to work operations. They follow set procedures in accompli...
- 2 Days Ago
Cook
- U.S. Department of Veterans Affairs
-
Fort Meade, SD
FULL_TIME
- SummaryThis part-time position is located in the Nutrition and Food Service at the Veterans Affairs Medical Center in Fort Meade, SD. The person in this position prepares nutritious, high qualify meal...
- 4 Days Ago
Wildland Firefighter - Direct Hire Authority.
- Bureau of Indian Affairs
-
Ridge, SD
FULL_TIME
- DutiesDirects the operation of a wildland fire engine ensuring the correct positioning, proper use and operation.Performs and directs others in starting pump engine, priming pump, adjusting engine spe...
- 5 Days Ago
Regulatory Affairs Director jobs at Popular Companies
Head of Regulatory Affairs
- Kaye/Bassman International
-
San Diego, CA
- Position Title: Head of Regulatory Affairs Location: Southern California Company Overview: We are partnered with a cutti...
- 6/12/2024 12:00:00 AM
Sr. Director of Regulatory Affairs - Oncology
- Mantell Associates
-
Boston, MA
- Mantell Associates is currently partnered with an innovative Biotech company, developing much-needed therapies for peopl...
- 6/12/2024 12:00:00 AM
Director of Regulatory Affairs
- Verano
-
Chicago, IL
- Verano Holdings Corp. (CSE: VRNO) (OTCQX: VRNOF), one of the U.S. cannabis industry’s leading companies based on histori...
- 6/12/2024 12:00:00 AM
Director of Regulatory Affairs
- Verano
-
- Verano Holdings Corp. (CSE: VRNO) (OTCQX: VRNOF), one of the U.S. cannabis industry’s leading companies based on histori...
- 6/12/2024 12:00:00 AM
Head of Regulatory Affairs
- Exegenesis Bio Inc
-
Ambler, PA
- Job Description Job Description Job Title: Head of Regulatory Science Reports to (Title): CEO Location: Remote, US Exemp...
- 6/11/2024 12:00:00 AM
Head of Regulatory Affairs
- EPM Scientific
-
- Our client, a clinical stage biotech company, is seeking an experienced and dynamic Head of Regulatory Affairs to join t...
- 6/10/2024 12:00:00 AM
Head of Regulatory Affairs
- Hiring Now!
-
West Hills, CA
- HELP US BRING THE GIFT OF HEALTH TO LIFE.Working at Pharmavite is an experience like no other. With a focus on complete ...
- 6/8/2024 12:00:00 AM
Director of Regulatory Affairs
- Catalyst Life Sciences
-
- Our client is actively looking for a (Senior) Director of RA/QA to join their growing team. This is a hybrid position su...
- 6/8/2024 12:00:00 AM
About South Dakota
South Dakota (/- dəˈkoʊtə/ (listen)) is a U.S. state in the Midwestern region of the United States. It is named after the Lakota and Dakota Sioux Native American tribes, who compose a large portion of the population and historically dominated the territory. South Dakota is the seventeenth largest by area, but the fifth smallest by population and the 5th least densely populated of the 50 United States. As the southern part of the former Dakota Territory, South Dakota became a state on November 2, 1889, simultaneously with North Dakota. Pierre is the state capital and Sioux Falls, with a populat...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$152,737 to $217,537
Most Popular Cities in South Dakota for Regulatory Affairs Director Jobs
What does a Regulatory Affairs Director do?
Regulatory Affairs Director in Gary, IN
At the Healthcare Professionals Group, our experienced team of Regulatory & Quality recruitment consultants are ready to discuss a variety of Regulatory Affairs Director jobs with you.
February 18, 2020
Regulatory Affairs Director in Springfield, OR
The regulatory affairs director might engage in reading and responding to letters from the FDA, including any “warning letters” about unapproved activities or products.
December 04, 2019
Regulatory Affairs Director in Richmond, VA
The office of regulatory affairs is a dynamic work environment where communication with employees at all levels within the organization is extremely important.
December 05, 2019