Director, Regulatory Affairs Strategy

About the Role

Location: Gaithersburg, MD
Duration: 6 months
Pay: $108.52 per hour

Location: Boston, MA
Duration: 6 months
Pay: $133.80 per hour

About Us

AstraZeneca puts patients first and strives to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

Role Overview

AstraZeneca’s pipeline of innovative medicines is consistently growing within Cardiovascular, Renal & Metabolism (CVRM). To meet the increasing demand of regulatory expertise, we continue to expand our regulatory functions through the recruitment of Regulatory Affairs Strategists. With us, you will get the opportunity to work across the spectrum of drug development to progress a rich and diverse pipeline of both small and big molecules. You will work across disciplines in an atmosphere of collaboration and inclusion where Regulatory Affairs is a respected voice and considered an equal partner in the business.

Key Responsibilities

• Play a key role in channelling our scientific capabilities to make a positive impact on changing patients’ lives.
• Influence the development of our innovative pipeline, define the regulatory strategy for our therapeutic assets, and engage with Health Authorities to effectively inform our development programs.
• Transform exciting science into valued new medicines for patients around the world.
• Strategic thinking is key within our function. The more experienced you are, the more accountability you will have for strategic leadership including responsibility for development and implementation of the global regulatory strategy for a product/group of products of increasing complexity.

Qualifications & Skills

• Advanced Degree in Life Science or related discipline.
• 5+ years of proven experience defining and implementing the regulatory strategy for a pharmaceutical organization.
• Extensive knowledge of regulatory affairs within one or more therapeutic areas in early and late development.
• Proven track record of regulatory drug development including product approval/launch.
• Experience in leading Major Health Authority interactions.
• Ability to think strategically and critically and evaluate risks to regulatory activities.
• Ability to work strategically within a complex, business critical and high-profile development program.

Benefits

Benefits - When it comes to working, we want to help take some of life’s pressures off - where we can. So, Kelly employees get access to great benefits, perks, and discounts.
- EnrollVB Program
- Teledoc
- Supplemental Medical
- Min. Essential Coverage
- Dental
- Vision
- Legal & Financial
- Accident
- Short Term Disability
- Critical illness
- Term Life
- Whole Life
- Access 2 Wellness - lower medication costs
- Kelly’s Life Advisor Wellness Program - access to counselors to assist with a wide range of issues, including Life Coaching sessions
- Retirement Savings
- Direct Deposit. Weekly pay
- Free skills enhancement and training with More than 6,000 courses and 55,000 eBooks and publications are available
- Employee Discounts/Perk Spot - Thousands of popular retailers and service providers, you can obtain discounts for almost anything you can buy.
- Holiday and Service plans where applicable