Regulatory Affairs Analyst

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

• Under close supervision, coordinates, assembles, retrieves, and/or authors technical and administrative documents, on a request basis, to regional Regulatory teams in support of major regulatory submissions and responses to health authority questions. Works with subject matter experts and global Regulatory staff, to obtain technical and summary documents. Requests official documentation from health authorities (e.g., CPPs, export certificates) and ensures this documentation is prepared (i.e., signed or legalized, apostilled) according to regional requirements.
• Prepares routine reports and summaries, for other groups within and outside RA, including but not limited to APR Section 12s and WWMA tables. Provides product-specific summaries of submission and registration activities on an ad-hoc basis for other groups within and outside RA.
• Under close supervision, supports Global Regulatory Leads through coordination of RA activities for low-complexity projects. Works with Regulatory GRLs and other functions to research and provide answers to basic regulatory questions.

Key Duties and Responsibilities:

1. Provision of Technical and Administrative Documents: Reviews and responds to requests, from Regional RA, for technical and administrative documents to be used in major regulatory submissions and responses to health authority questions. Actively communicates with customers to prioritize completion of individual requests based on urgency, and escalates questions or issues to management and/or subject matter experts in Irvine.

2. Preparation of Routine Reports and Summary Information: Prepares product-specific reports and summaries of submission and registration activity for customers internal and external to Regulatory Affairs. Examples include but are not limited to APR Section 12s and WWMA tables. Assist in entry and cleanup of data stored in various Regulatory Affairs systems and tracking documents.

3. Project Support for Global Regulatory Development: For low-complexity projects, coordinates Regulatory Affairs activities. Works with Regulatory Affairs and SMEs to answer simple regulatory questions.

4. Process Improvement: Assists in process development/improvement initiatives. Provides input to teams implementing/updating systems and processes based on tactical experience.

Qualifications

MINIMUM REQUIREMENTS

Education and Experience

• Bachelor's degree or country equivalent in a life sciences discipline.
• 0 to 2 years experience working in a regulatory affairs or related function.

Essential Skills and Abilities

• Excellent verbal and written communication skills
• Ability to read and understand health authority guidance
• Ability to interpret and summarize information from multiple sources including regulations, health authority guidances, and internal documents
• Ability to multitask and prioritize under moderate workload with some supervision
• Computer literate with proficiency in MS Office applications
• Proficiency in document management systems and/or ability to quickly learn new systems and technologies

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Keyboard use (greater or equal to 50% of the workday)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.