My client are seeking an experienced and strategic Associate Director of Regulatory Affairs to join our Oncology Regulatory team, with a primary focus on EU and International markets (ex-US). The successful candidate will play a key leadership role in the development and execution of regulatory strategies to support clinical development and registration of oncology products across European and global markets.
Key Responsibilities:
* Lead the development and implementation of regulatory strategies for oncology programs in the EU and international markets, ensuring alignment with global regulatory objectives.
* Serve as the Regulatory Affairs lead for assigned projects, representing the function on cross-functional teams and leading interactions with EU and ex-US health authorities (e.g., EMA, MHRA, Swissmedic, TGA, PMDA, etc.).
* Prepare, review, and oversee high-quality regulatory submissions including Clinical Trial Applications (CTAs), Scientific Advice briefing packages, Orphan Drug Applications (ODAs), MAA dossiers, variations, and responses to regulatory questions.
* Monitor and interpret evolving regulatory requirements, guidelines, and industry trends in the oncology space; communicate implications and recommend appropriate actions.
* Contribute to the development of global regulatory strategies and alignment of regional activities with US/global plans.
* Support interactions with external partners, CROs, and consultants as needed to deliver high-quality submissions on time.
Qualifications:
* Advanced degree (PhD, PharmD, MSc, or equivalent) in life sciences or a related field preferred.
* Minimum 7–10 years of Regulatory Affairs experience in the pharmaceutical or biotechnology industry, with at least 3–5 years focused on oncology and EU/international markets.
* Proven track record of successful submissions and interactions with regulatory agencies in the EU and/or other international regions.
* Strong knowledge of regulatory requirements across the drug development lifecycle, including CTA/MAA processes, scientific advice, and post-approval activities.
* Experience working on cross-functional teams in a global matrix environment.
* Excellent written and verbal communication skills; able to influence and collaborate effectively across levels.
* Strategic mindset with attention to detail and the ability to manage multiple priorities in a fast-paced environment.
Preferred Experience:
* Experience with advanced therapy medicinal products (ATMPs), biologics, or immuno-oncology.
* Direct experience with EMA Scientific Advice, PRIME designation, or accelerated pathways.
* Familiarity with international regulatory systems (e.g., LATAM, MENA, APAC) is a plus.