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About the Role

The Regulatory Affairs Manager (RAM) is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The RAM contributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval. The RAM provides regulatory expertise and guidance on procedural and documentation requirements to GRET, GRST and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.

Responsibilities

Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
Provide regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s).
Develop, execute and maintain submission delivery plans and submission content plans.
Proactively provide status updates to designated stakeholders.
Coordinate the input, maintenance and revision in the Planit project plans for assigned projects.
Highlight unforeseen changes in resource demand in a timely manner to Lead RPM and line manager.
Identify regulatory risks and propose mitigations to Lead RPM and cross functional teams.
Support operational and compliance activities for assigned deliverables.
Provide coaching, mentoring and knowledge sharing within the RAM skill group.
Contribute to process improvement.

Requirements

Bachelor's degree in a scientific discipline, Regulatory Sciences, Pharmacy, or a related field.
3+ years of Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience.
General knowledge of drug development.
Strong project management skills.
Leadership skills, including experience leading multi-disciplinary project teams.
Master's, PharmD, or PhD degree in Science, Regulatory Sciences, Pharmacy, or another related discipline.
5+ years of Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience.
Managed regulatory deliverables at the project level.
Thorough knowledge of the drug development process.
Knowledge of AZ Business and processes.

Skills

Excellent written and verbal communication skills.
Cultural awareness.
Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions.
Proficiency with common project management (e.g., MS Project) and document management tools.
Ability to work independently and as part of a team.
Influencing and stakeholder management skills.
Ability to analyze problems and recommend actions.
Continuous Improvement and knowledge sharing focused.

Experience Level

3+ years of Regulatory experience
5+ years of Regulatory experience

Education Level

Bachelor's degree in a scientific discipline, Regulatory Sciences, Pharmacy, or a related field
Master's, PharmD, or PhD degree in Science, Regulatory Sciences, Pharmacy, or another related discipline

Salary/Compensations

$109,244.80 - $163,867.20 USD Annual

Benefits

Short-term incentive bonus opportunity
Equity-based long-term incentive program (salaried roles)
Retirement contribution (hourly roles)
Commission payment eligibility (sales roles)
Qualified retirement program [401(k) plan]
Paid vacation and holidays
Paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage

About the Company

At AstraZeneca we’re dedicated to being a Great Place to Work.
Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit.
There’s no better place to make a difference to medicine, patients and society.
An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development.
We’re on an exciting journey to pioneer the future of healthcare.

Equal Opportunity

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees.
In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics.
If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.