Senior Manager, Regulatory Affairs

Senior Manager, Regulatory Affairs - Tokyo Osaka Remote/office hybrid

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

We are currently seeking a Senior Manager, Regulatory Affairs to join our diverse and dynamic team. As a Senior Manager, Regulatory Affairs at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of inNvative treatments and therapies.

What you will be doing:

• Participate in provision of regulatory expertise in strategic drug development across multiple areas.

• Take part in preparation of strategic development and submission plans.

• Be involved in the regulatory affairs activities across the ICON portfolio and be an expert and advisor to ICON clients (externally and internally).

• Be a trusted partner - represent the Regulatory Affairs Department in business development activities and generate new business opportunities.

• Contribute to at least two of the following areas: interactions with regulatory agencies, early phase consulting, development planning (PDP/RDP/CDP), scientific/agency advice, orphan drugs/pediatric development, medical devices, regulatory intelligence, due diligence, strategic CT support/GCP compliance, biological/biotech/biosimilars, small company support (incl. SOPs development etc.).

• PMDA 厚生労働省等の規制当局との面談・折衝
• 薬事分析（Regulatory Assessment）の実施
• Global PRA（欧州・アジア各国）およびクライアントとの協働
• Global PRAへの日本に於ける薬事要件のインプットと協議、協働
• 社内他部門との連携と薬事観点のアドバイス提供
• 薬事関連資料（各種面談資料、治験届等）の作成・作成リード
• 新薬申請から承認取得までの各種対応のリード
• 新規クライアントに対する、薬事戦略（Regulatory Strategy）の提案やプレゼンテーション
• チームメンバーのスキルアップへ向けたメンター業務

Your profile:

• EU/APAC: In-depth proven regulatory affairs expertise. Minimum of 7 years’ experience, supervisory experience, and pharmaceutical/CRO industry experience.

• US/LATAM/CAN: A minimum of 7 years regulatory affairs experience including supervisory experience and a minimum of 6 years pharmaceutical/CRO industry.

• Demonstrable experience within regulatory affairs, including development of regulatory strategies, document writing, marketing authorization applications, clinical trials, post-licensing activities, and direct regulatory agency interaction.

• Strong organizational skills, ability to manage multiple tasks, and meticulous attention to detail.

• Excellent written, verbal, and management skills, as well as demonstrated presentation skills, problem-solving ability, strong interpersonal skills, and the ability to plan/organize

• 開発薬事の担当経験　（当局対応、申請業務など）
• 規制当局との折衝やコミュニケーション、円滑なやり取りなどの実務経験
• 英語でのコミュニケーションスキル、文書作成能力

What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Are you a current ICON Employee? Please click here to apply