Associate Director - Regulatory Affairs

2525 Dupont Dr, Irvine, CA 92612, USA

Full-TimeDepends on ExperienceMid-LevelBachelors

Job Description

The Associate Director/Director of Regulatory Affairs, under the accountability of the Senior Director, Regulatory Affairs, helps lead teams by providing regulatory strategy and support to global development. Represents RA at project team meetings and manages/oversees regulatory workflow between departments as well as CROs as required at the study team level. Lead and facilitate development of Health Authority (HA) meeting requests and briefing packages in preparation for HA meetings. Lead and facilitate team preparation for FDA meetings.

Where is this job?

This job is located at 2525 Dupont Dr, Irvine, CA 92612, USA

Job Qualifications

5-7+ years relevant regulatory or clinical development pharmaceutical/biotechnology experience
Prior experience leading NDA/sNDA and/or BLA/sBLA filings
prior experience with MAAs a plus
Prior work experience in hematology/oncology highly desirable

Required Skills

Documentation
Time Management
Analytical skills
Drug development process

Soft Skills

Multitasking
Process Improvement
Verbal communication
Detail Oriented
written communication

Compensation

According to JobzMall, the average salary range for a Associate Director - Regulatory Affairs in 2525 Dupont Dr, Irvine, CA 92612, USA is between $138,000 and $144,000 per year.

Additional Information

AbbVie is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Required LanguagesEnglish

Job PostedAugust 20th, 2021

Apply BeforeMay 22nd, 2025

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