Senior Regulatory Affairs Manager

薬事マネージャー | 国内リモート

SENIOR REGULATORY AFFAIRS MANAGER (M/F/X) – remote within Japan

Fishing around for a new challenge?

GENERAL INFORMATION

Position: 薬事マネージャー

Location: 国内リモート

Starting: 要相談

Position: Senior Regulatory Affairs Manager (m/f/x)

Location: remote within Japan

Starting: at the next possible date

YOUR NEW WATERS:

THE FORCE builds companies for companies in the healthcare, pharmaceutical, and medical devices sector.

We encourage work in a flexible surrounding and as a diverse group when it comes to gender, nationality, religion, and ways of working. This unique culture is aimed to integrate employees and partners seamlessly into one organization.

Likewise, this organization shall easily adapt to customer organizations. Our unique way of operation will release THE FORCE to solve customer problems in a fast, effective, and efficient manner.

People are our strength:

In all of this, people are and will be at the center of our attention, and the most valuable asset we have: People are our strength. They make us THE FORCE.

For you, this means you are flexible in your working hours, your location, and your work itself. You will also have a big say in what exactly you and we are aiming for. But above all, we are interested in you as a person and focus on your specific talents. We are looking for that certain something – and will give it to you in return.

YOU DON’T ALWAYS SWIM WITH THE TIDE:

In a growing company, we are looking for people who don’t feel like a fish out of water in new situations and with new customers.

You are curious to explore your regulatory knowledge on different product types? You are eager to help foreign customers to bring their products to Japan with your expertise? You can easiliy switch between high-level strategic work and hands-on basic regulatory tasks?

Then come join us at THE FORCE!

THERE ARE PLENTY OF FISH IN THE SEA, BUT YOU MIGHT BE THE ONE WE’RE LOOKING FOR IF...

• 薬事戦略の立案から、承認取得後の変更管理・ライフサイクル対応、国内薬事業務まで、幅広い薬事業務のご経験をお持ちの方
• 複雑な薬事課題に対しても、これまでのご経験を活かし、主体的かつ柔軟に対応できる方
• PMDA等の規制当局、クライアント、パートナー企業との折衝・コミュニケーション経験をお持ちの方
• 日本における医薬品および関連製品の薬事手続き、関連法規・ガイドラインに関する知識をお持ちの方
• これまで経験のない製品領域や新しいテーマにも、前向きに取り組める方
• ビジネスレベルの日本語力を有し、国内外のクライアントに対して的確なサポートができる方
• 海外クライアントとのやり取りに対応できる英語力をお持ちの方は歓迎します
• ...you are well-versed in our wide range of activities from regulatory strategy to life-cycle measures or local regulatory activities.
• ...your experience allows you to handle complex regulatory topics swimmingly.
• ...communication with health authorities (i.e. PMDA) and clients or partners isn’t new to you.
• ...you are knowledgable when it comes to regulatory procedures and guidelines in Japan for medicinal products and beyond.
• ...you enjoy exploring new product types.
• ...your business fluency in Japanese enables you to provide our customers with the best possible support.
• Strong English skills to assist our international customers are an advantagefor this role.

THERE ARE PLENTY OF FISH IN THE SEA, BUT YOU MIGHT BE THE ONE WE’RE LOOKING FOR IF…

• 薬学、生命科学、または関連する自然科学分野の学位をお持ちの方
• 国際的な環境において、薬事業務の実務経験を10年以上お持ちの方 臨床開発または薬事戦略に関するご経験をお持ちの方は尚歓迎します
• 社内外の関係者やクライアントと円滑に連携できる、高いコミュニケーション能力をお持ちの方
• 多国籍なチーム環境において、協調性を持って業務に取り組める方
• 細部まで注意を払い、正確かつ丁寧に業務を進められる方
• You have an academic degree in pharmacy or a related scientific field.
• With at least 10 years of experience in Regulatory Affairs in an international environment, preferably in clinical of regulatory strategy, you are able to navigate every challenge.
• Your strong communication skills allow you to work with co-workers and customers alike.
• You are an excellent team worker and thrive in a multi-national environment.
• An eye for detail completes your skills.

HOW YOU’LL HOOK US:

You are flexible in your working hours, your location, and your work itself. You will also have a big say in what exactly you and we are aiming for. But above all, we are interested in you as a person and focus on your specific talents.

We are looking for that certain something – and will give it to you in return. Odd bird, crazy goose, or wise owl? We welcome birds of all feathers!

READY FOR A SEA CHANGE?

All of this sounds exactly like the new challenge you’ve been looking for? Test the waters and send your application via our application form to Dr. Andrea Schüssele.

Please note that we require all application documents in English.

Apply now!

Use our application form to directly apply as Senior Regulatory Affairs Manager.