Regulatory Affairs Manager
We are seeking a talented Regulatory Affairs Manager to play a pivotal role in supporting EU regulatory activities for oncology drug development.
About the Role
This is an exciting opportunity to contribute to groundbreaking clinical development programs while collaborating with global experts and building relationships across the EU regulatory network.
Responsibilities:
* Developing regulatory strategies for oncology programs by researching guidelines, EU precedents, and emerging trends.
* Managing CTA submissions via CTIS for multiple EU member states, ensuring compliance with EU requirements.
* Organizing, preparing, and reviewing CTA amendments, annual reports, and other regulatory documents.
* Performing critical analyses of clinical and preclinical data to develop interpretations and conclusions.
* Leading EU Scientific Advice requests and coordinating EMA and EU national agency meetings.
* Monitoring newly published EU Commission and EMA guidelines to ensure compliance and provide training for scientific staff.
* Representing the company in engagements with EMA scientific committees, EU national agencies, and industry associations.
Requirements
To be considered for this role, you will have:
* An advanced degree in a scientific discipline.
* At least 4 years of regulatory experience, with a focus on clinical development.
* Proven experience supporting EU Clinical Trial Applications through approval and study start-up.
* Familiarity with EMA processes such as scientific advice, orphan designation, and PIPs.
* Experience in oncology regulatory strategy is an advantage.
* A strong ability to negotiate and express clear positions to stakeholders at all levels.
What We Offer
We offer a comprehensive benefits package, which includes:
* Health and wellness programs.
* Equity awards.
* Annual bonuses.
* Paid time off for eligible employees at all levels.
Why Join Us?
We believe in fostering innovation, collaboration, and growth. You'll have the opportunity to work with a passionate team dedicated to advancing science and improving patient outcomes.