Regulatory Affairs Assistant

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Job Summary:  
The Regulatory Affairs Assistant is responsible for providing administrative support, generation and facilitation of regulatory documents in accordance with federal regulations, ICH Guidelines, good Clinical Practices (GCPs) and WTI Standard Operating Procedures (SOPs).

Essential Functions
•    Conducts all regulatory activities in accordance with Institutional Review Board (IRB) guidelines, Good Documentation Practices (GDPs), Good Clinical Practice (GCP) standards, Standard Operating Procedures (SOP’s), Quality procedures (QA/QC), OSHA guidelines and other state and local regulations as applicable, ensuring strict compliance to the study protocol at all times
•    Generates, facilitates and maintains all study related regulatory documents from pre-study through study close out, ensuring quality, accuracy, and timeliness
•    Serves as site support on Institutional Review Board (IRB) processes
•    Maintains regulatory documents according to GCP, ICH, FDA, and Sponsor requirements
•    Prepares and maintains records for archiving and/or retrieval
•    Acts as a liaison between internal departments, Sponsors, and IRBs to ensure quality, accuracy and timely turnaround of regulatory documents
•    Reviews all regulatory documents prior to Sponsor/Monitor/Regulatory Authority visits
•    Participates as a supporting member of the study and site team
•    Provides support and assistance as needed by the organization

Your Skills and Experience

Any equivalent combination of education, training, and/or experience that fulfills the requirements of the position will be considered.

Education/ Experience

• High school Diploma or GED equivalent required
• Bachelor's Degree preferred
• A minimum of one (1) year of clinical research experience, regulatory experience is preferred

Knowledge, Skills, Abilities (Other pertinent qualifications/skills/knowledge necessary to perform the essential functions of the job)

• Possesses an understanding of medical terminology and the application of scientific/medical and clinical concepts to conduct clinical trials
• Possesses an understanding of GCPs and federal regulations
• Possesses strong organizational and time management skills
• Excellent interpersonal, organizational, and time-management skills
• Able to work under extremely tight deadlines
• Strong analytical and decision making skills
• Able to coordinate workloads to meet extremely tight deadlines
• Possesses exceptional customer service and public relations skills, professionalism, and the ability to communicate effectively with internal and external parties
• Proficient in MS Office Suite (Word, Excel, Outlook, PowerPoint)
• Able to speak, read, and write fluent English required
• Able to speak, read and write fluent in Spanish preferred

Physical Requirements and Working Conditions:

• Incumbents in this class are subject to extended periods of sitting, standing, walking, stooping, bending, and lifting materials and supplies weighing up to 25 pounds.

Physical Demands:
•    Routine keyboarding

Work Environment:
•    Office and clinical environment
•    Non-supervisory, non-managerial

How We’ll Take Care of You

We offer a competitive benefits package, including:
•    Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls. 
•    Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan. 
•    Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, 13 paid Holidays and 3 paid floating holidays. 
•    Life and Disability Protection: Company paid Life and Disability insurance. 
•    Additional benefits include, but not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

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Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.  

Please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Request a reasonable accommodation by sending an email to AskHR@tevapharm.com with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address. 

Important notice to Employment Agencies - Please Read Carefully 

Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities.  All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.