Regulatory Affairs Analyst (Mays Cancer Center)

Job Description
Under general supervision, responsible for assisting with obtaining government approval for new products that are covered by government regulations, including the preparation of marketing applications.
Responsibilities

• Prepares and submits new studies and amendments to the appropriate regulatory agencies within and outside the institution in a timely manner.
• Collaborates between the Principal Investigators (PI), research staff and the Institutional Review Board (IRB) regarding protocol reviews, approvals, and amendments.
• Obtains documents from all involved entities and ensures that information flow is complete and timely.
• Provides periodic status reports to the principal investigator and research staff as required.
• Processes new studies for internal review and serves as the contact for completion and collection of the regulatory affairs questionnaire for Sponsors/Contract Research Organizations (CRO).
• Processes Investigational New Drug (IND )Safety Reports, attends internal meetings such as exit meetings for study monitors and auditors, disease team meetings, protocol reviews, etc.
• Serves as the primary regulatory contact for responding to internal audits.
• Performs all other duties as assigned.

Qualifications

• Experience in a clinical research setting, preferably in Regulatory Compliance.
• Knowledgeable of current FDA guidance/recommendations and all regulations regarding research protocols.
• Ability to write reports and business correspondence.
• Possess effective organizational skills, attention to detail, problem solving skills, and the ability to work on multiple tasks.
• Must have good time management skills and be able to meet deadlines.
• Strong verbal, written and interpersonal communication skills.

Education:

Bachelor's Degree degree is required; an advanced degree in such fields as Public Administration, Public Policy or Law is preferred.

Required Skills
Three (3) years of experience in a government relations environment is required. Experience on Capitol Hill or in a related science, technology, or higher education policy position is preferred.
About Us Benefits Overview UT Health San Antonio offers an excellent benefits package for its employees. Employees who work at least 20 hours a week, with an appointment of at least 4.5 months, are eligible for benefits.

Medical - UT SELECT Medical insurance is offered free for employees and administered by Blue Cross and Blue Shield of Texas. Family members can be added to the plan through payroll deduction. Employees and their dependents can also receive discounted copays and coinsurance when using UT Health Physicians, a network of 800 premier physicians including more than 100 specialists. Employees receive $50,000 of group term life insurance and $50,000 of basic accidental death and dismemberment insurance for free, with options to purchase additional employee and dependent coverage for both at group rates.

Dental - Three dental insurance plan options are available for employees and their families through Delta Dental Insurance Company, two PPOs and one dental HMO plan. Both PPO plans allow employees to choose any licensed dentist.

Vision - Fully insured Vision Care benefits are offered by Superior Vision Services. Two vision plan options that offer either standard or enhanced vision benefits.

Disability - Employees can enroll in the Disability Insurance which provides income if a non-work related illness or injury prevents you from working.

FSAs - Employees can enroll in flexible spending accounts (FSAs) to set aside money from earnings before taxes for qualifying dependent day care expenses or out-of-pocket health care expenses.

Retirement - Employees are eligible for either the Teacher Retirement System (TRS) or the Optional Retirement Plan (ORP). TRS is a defined benefit retirement plan which UT Health matches employee contributions. ORP is for eligible faculty staff employees. Voluntary retirement programs are also available to invest before- or after-tax dollars with the choice of five quality retirement plan providers.

Time Off - A generous leave program offers multiple paid leave options:

• Front-loaded Paid Time Off: 128 to 208 hours (16 to 26 days) of Paid Time Off based on years of service, given at the start of each fiscal year. PTO may be prorated in year one based on date of hire.
• Extended Illness Bank: 8 hours (1 day) accrued per month which can be used for illness or injury after one day of Paid Time Off is taken.
• Paid Family Leave: Up to 240 hours (6 weeks) to care for a spouse, child, or parent after 6 months of consecutive employment.
Holidays: 12 set paid holidays each year.

Discounts - Employees enjoy a range of discounts on services, tickets, and gym membership.

EEO Statement UT Health San Antonio is an equal employment opportunity and affirmative action employer. It is our policy to promote and ensure equal employment opportunity for all individuals without regard to race, color, religion, sex, gender identity, national origin, age, sexual orientation, disability, or veteran status.