Regulatory Project Manager (CMC)

At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases.

Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world.

We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.

Position Summary

The Manager, Regulatory Project Management (CMC), develops and maintains detailed project plans and timelines for deliverables including briefing books, INDs, CTAs, and other projects, while engaging with cross-functional stakeholders to drive timeline adherence and successful on-time completion of multiple documents.

This role is based in Santa Monica, CA and reports to the Associate Director, Regulatory Affairs CMC.

Responsibilities

• Create detailed project plans for regulatory deliverables in support of health authority interactions in concert with the cross-functional team to successfully produce sophisticated, high-quality on-time submissions.
• Collaboratively support the maintenance of timelines and project plans such that deliverables are completed on time with high quality.
• Facilitate communication between functional areas to maintain successful timelines.
• Understand and communicate regulatory strategy and project plans cross-functionally.
• Analyze current processes and workflows to provide suggestions for process optimization.
• Track project plans for internal deliverables including the development of standard operating procedures and other departmental maturation activities.
• Track and prepare project information and activities, including minutes, timelines, action items, and function-specific deliverables.
• You will also be responsible for authoring documents and / or standard operating procedures for regulatory project management.
• In concert with other staff (IT, RA, cross-functions), supports the development and execution of Regulatory Information Management systems and processes, where required.
• Manage and track vendors, consultants, and additional external stakeholders and serve as a liaison with internal stakeholders.
• You will have department- and group-level influence.

Education and Experience

BA / BS degree or equivalent degree in related field plus, 3+ years of experience in regulatory project management, or 5+ years of experience in regulatory affairs strategy and 2+ years in project management.

Required Abilities

• Execution of complex project plans and timelines.
• Strong working knowledge of relevant software platforms.
• Excellent interpersonal, organizational, written and oral communication skills with the ability to work collaboratively in a team environment.
• Able to effectively communicate progress toward milestones, opportunities, and risks to all stakeholders.
• Understanding of the drug development process.
• Familiarity with regulatory guidelines and requirements, with a focus on US FDA and EMA.
• Problem-solving, collaborative mindset.
• Excellent soft skills.

When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions.

That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible.

We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

The annual base salary for this position ranges from $128,651 to $192,977. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience.

If hired, employee will be in an "at-will position" and we reserve the right to modify base salary (and 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.

Benefits

• Short-term incentive bonus opportunity
• Equity-based long-term incentive program
• 401(k) plan
• Paid vacation and holidays; paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage.

LI-Onsite

DE&I Statement

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.

We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.

We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.