Sr. Manager, Global Regulatory Affairs

Role Summary

As the US Regulatory Lead, you will be responsible for developing and executing US regulatory strategies as part of the Global Regulatory Affairs team. You will also oversee the preparation, submission, and management of regulatory filings interactions with the FDA. This role requires outstanding collaboration abilities, as you will play a key role in proactively identifying regulatory risks and developing mitigation strategies ensuring compliance with relevant regulatory requirements, company policies, and industry standards, ensuring impactful outcomes and solutions for patients. This is a hybrid role, requiring 3 days office attendance per week.

Responsibilities

• Direct US regulatory strategies for assigned projects, supporting the global clinical development and lifecycle
• Identify and assess regulatory risks associated with product development and define strategies to mitigate these risks
• Set strategic direction and lead the US regulatory submission process, including INDs, NDAs, sNDAs and briefing packages
• Support the development of the US label and represent US regulatory strategy at global labeling team meetings
• Monitor and analyze FDA activities and assess their specific impact on your projects
• Foster positive interactions with the FDA
• Represent the department in US project teams, committees, and external meetings

Qualifications

• Bachelor's Degree in Life Science or related discipline with 7 years experience, Masters degree with 5 years experience
• Strong and proven experience within the pharmaceutical/biotechnology industry, including significant experience in Regulatory Affairs Strategy
• Hands-on experience in preparing major regulatory filings with the FDA and supportive amendments or supplements
• Strong leadership and communication skills, with the ability to guide and collaborate effectively across functions and levels of the organization
• Energetic, creative, analytical problem solver who acts independently yet communicates broadly
• Strategic thinker with the ability to anticipate and mitigate regulatory risks
• Expertise in the current regulatory landscape and evolving guidance