Associate Regulatory Affair Director

EMPLOYER:              AstraZeneca Pharmaceuticals LP

TITLE:                       Associate Regulatory Affairs Director

LOCATION:              Gaithersburg, Maryland

HOURS:                     Full-Time; Mon-Fri (40 hours/week)

DUTIES:                    Provide strategic regulatory input to the development, commercialization and life cycle management of the assigned product(s). Serve as the regional regulatory leader. Provide ad hoc project input to support regional RAD or GRLs for specific project tasks. Play a key role influencing Regulatory authorities through regular contacts to improve Regulatory outcomes. Undertake leadership of cross- functional teams in major Regulatory Submissions (NDA, IND/CTA), Health Authority Interactions, Label discussions, and securing NDA/BLA Approvals. Act as a member of the Global Regulatory Strategy Team (GRST) accountable for providing the region-specific Regulatory strategy and advice. Serve as the face of the company with Health Authorities.

REQUIREMENTS:   Must have a Bachelor's degree or foreign equivalent in Pharmaceutical Science, Regulatory Affairs, or in a related field plus five (5) years of progressively responsible experience in the position offered, as a Regulatory Affairs Specialist, or in a related occupation. Must have five (5) years of progressively responsible experience in the drug development sector with each of the following: Leading new drug applications (NDAs) Biologics Drug Application (BLA) regulatory strategy in late stage drug development projects; Participating and channeling CTAs/INDs (Clinical Trial Applications/Investigational New Drug Applications) regulatory strategy in early stage drug development projects; Developing global drug development regulatory pathways, clinical pharmacology sections, Clinical Overview, Clinical Summaries, quality summaries, briefing documents strategies, regulatory strategy document, and target product labeling; Interfacing with FDA and other Health Authorities for regulatory strategies, including regulatory labeling strategy;  Participating in regional regulatory strategic areas including orphan designation, scientific advice, pediatrics, and regulatory defense; Coordinating cross-functional teams in major health authority interactions, setting up strategy and planning for interaction; and Contributing to regulatory approvals including leading response team and labeling negotiations.

Incentives offered through the employee referral program are applicable to this position. For more information,

please visit our Global Recruitment Page within Workday Recruiting.

The annual base salary (or hourly rate of compensation) for this position ranges from $183,352.00 to $202,773.60. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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