Senior Associate, Regulatory Affairs
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.
Responsible for specific regulatory documents preparation, review and submission, and assist with compliance issues. Performs the coordination and preparation of document packages for regulatory submissions from all areas of company as well as internal audits and inspections. Keeps abreast of regulatory procedures and changes.
- Manage the day-to-day regulatory affairs activities for specific projects and related domestic and international applications (i.e, INDs, CTAs, NDAs, Orphan Designations) including prepare, coordinate and review multiple submissions and projects effectively. Ensure consistency, completeness and adherence to standards for all regulatory submissions.
- Participate in the study management & collaborate with regulatory operations as it relates to all regulatory submissions
- Execute, with appropriate guidance and supervision, product development and regulatory strategies regarding submissions and compliance issues
- Acquires and maintains thorough knowledge of regulatory requirements; stays abreast of developing regulatory changes affecting products/projects
- As required, support study managers per assigned product teams as it relates to attendance and participation at study team meetings
- Support study managers for major filings (e.g., sNDA) with emphasis on Module 1 deliverables requiring coordination with other functions accordingly
- Ability to work either independently with minimal direction separately or within project teams, committees, etc. to attain group goals
- Ability to creatively complete activities within the allotted, sometimes aggressive, time schedules
- Thorough working knowledge and understanding (application of knowledge/experience) of FDA regulations
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff
- Well organized, detail oriented, effective written and oral communication skills, and good grammatical skills
- Computer literate
- 2 years of medical device/pharmaceutical/biotechnology industry experience
- Required Experience: Experience and/or knowledge in the preparation of INDs, ex-US CTAs and all supportive amendments or supplements
- Required Education: Minimum of a BA/B.S in a scientific, healthcare or related field
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Level Code
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.