The Opportunity:

As part of our expanding European organization, we seek a strategic and hands-on Associate Director, Regulatory Affairs, Europe who will provide regulatory leadership for designated programs at RevMed. 

The candidate will be responsible for the preparation & end-to-end execution of regulatory MAA filings across the EU, EEA, UK and Switzerland for oncology programs, ensuring alignment of the European regulatory strategy with the global and regional company`s objectives.

They will independently represent regulatory affairs on global and regional cross-functional teams, delivering targeted, strategic and actionable regulatory guidance for oncology programs across one or more therapeutic areas.

The candidate must have a thorough understanding of oncology drug development, applicable European regulations and will be supporting engagement with health authorities including the EMA/MHRA/Swissmedic ensuring successful regulatory outcomes.

The role will report to the Director, Regulatory Affairs, Europe.

Primary Responsibilities:

• Research regulatory requirements and identify relevant precendents to develop well-vetted, actionable strategies for assigned programs.

• Independently plan, prepare and coordinate regulatory pathways for Marketing Authorisation Applications, and lifecycle management activities in the European Region.

• Support regional regulatory planning and oversee integrated filing plans, including timelines, deliverables, and critical path activities.

• Coordinate MAA submissions, including dossier readiness, and cross-functional alignment.

• Serve, when applicable, as the primary regulatory liaison with European health authorities (e.g., EMA and EU/EEA national agencies), supporting the interactions and communications.

• Support preparation and review of key regulatory submissions, including Scientific Advice Briefing Packages, Orphan Designation Applications, and Paediatric Investigation Plans.

• Identify, assess, and proactively mitigate regulatory risks impacting timelines or outcomes; communicate progress and risks to Regulatory Affairs leadership.

• Partner with regional and global regulatory leads to ensure alignment between global and regional regulatory strategies.

• Act as a strategic partner to cross-functional teams, including R&D, Medical Affairs, Safety, Market Access, and Commercial.

• Ensure compliance with applicable European regulatory, pharmacovigilance, and governance requirements.

• Monitor and interpret evolving European regulatory requirements, guidelines, and trends, and communicate their impact across functions.

• Oversee external vendors and CROs to ensure timely, high-quality regulatory submissions and approvals.

Required Skills, Experience and Education:

• Degree in biological or life sciences, pharmacy, medicine, or related fields. An advanced degree (PhD, PharmD, MSc) is desirable.

• A minimum of 8 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 7 years in Regulatory Affairs including a regulatory strategy role.

• Significant experience with oncology drug development highly preferred.

• Deep understanding of European regulatory frameworks and oncology guidelines.

• Demonstrated success in EMA/MHRA submissions and approvals, including but not limited to MAA , Paediatric, Orphan Designations experience.

• Direct hands-on experience in the preparation and submission of large, complex regulatory documentation to support health agency review/approval procedures, post approval activities.

• Experience interacting with the EMA and other European agencies.

• Demonstrated experience in strategic problem-solving with health agencies and leading internal teams on regulatory strategy.

• Experience in representing Regulatory Affairs on cross-functional teams and presenting to senior management.

• Excellent interpersonal, written, and presentation skills with the ability to effectively communicate complex regulatory strategies to diverse audiences.

• Thrives in fast-paced, dynamic environment and ability to multi-task independently with limited supervision.

• Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.

• Excellent leadership, communication and stakeholder management skills.

• Strong project management and organizational skills.

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