We use cookies to deliver our services. By visiting our website, you agree to the use of cookies as described in our
Privacy Policy.
Click here to hide this one-time notice.
Click here to hide this one-time notice.
Daijob.com is Japan's definitive job site for multilingual professionals.
Job Search
Updated 2024-03-22
Activated 2024-03-22
Activated 2024-03-22
Regulatory Operation Director at Global Leading Pharma
- Recruiter
- Senior Level
| This posting is managed by: | Michael Page International Japan K.K./マイケル・ペイジ・インターナショナル・ジャパン株式会社 |
|---|---|
| Company Name | Company is not publicly visible |
| Job Type |
 Medical/Pharmaceutical/Bio/Fabric/Food - Patent Medical/Pharmaceutical/Bio/Fabric/Food - Clinical R & D |
| Industry | Pharmaceuticals |
| Location |
Asia
Japan
Tokyo
|
| Job Description |
Take lead in regulatory submission activities for the business to get product approval. Be involved in publishing and archiving activities to ensure best practices. Description * Lead in regulatory operations in submissions and being informed of up to date regulatory information to manage tracking systems * Be the main point of contact in electronic submissions, including new data requirements tracking regulatory data for RIM system * Create eCTD documents and electronic JNDA Data to the PMDA and other health authorities * Manage any regulatory dossiers to align with regulatory operations * Provide expertise in global SOPs in regulatory operations to relevant teams Profile * University degree in scientific or related fields * High fluency in English and Japanese (Non-native level speakers will not be selected) * Extensive experience in RA or regulatory operations in the pharmaceutical industry * Knowledge of CTD/eCTD requirements to submit to health authorities * Exposure in compiling/publishing to prepare for overseas submissions (ex. US/EU) Job Offer * Competitive salaries and benefits (potential RSUs) * Great work life balance * Global working environment * Amazing career development in regulatory area * Work with key leaders who are solving unmet medical needs Page Group Japan is acting as an Employment Agency in relation to this vacancy. |
| Company Info |
* One of the top global patient-centric pharmaceutical companies in the industry * Delivering cutting-edge therapies and products to patients with unmet medical needs * Specializing in rare disease and orphan drug products with several blockbuster therapies out on the global market * Global working environment with extensive communication with global stakeholders * Hybrid style working style |
| English Level | Business Conversation Level (TOEIC 735-860) |
| Japanese Level | Native Level |
| Salary | JPY - Japanese Yen JPY 11000K - JPY 14000K |
Additional listings by this company
- 年収~900万円＜東京or関西＞糖尿病領域MSL/未経験応募可 / JPY - Japanese Yen JPY 6000K - JPY 8000K
- バイオテクノロジー企業 アカウントマネージャー / JPY - Japanese Yen JPY 5000K - JPY 10000K
- アプリケーションエンジニア - 欧州化学メーカー / JPY - Japanese Yen JPY 4000K - JPY 9000K
- 糖尿病領域メディカルサイエンスリエゾン グローバル製薬 / JPY - Japanese Yen JPY 6000K - JPY 10000K
- CMC RA Manager at Global Renown Biopharma / JPY - Japanese Yen JPY 10000K - JPY 13000K
- MSLリード/年収〜1,500万円：外資製薬 / JPY - Japanese Yen JPY 12000K - JPY 15000K
- MSLマネージャー（部下ナシ）/希少疾患領域 / JPY - Japanese Yen JPY 8000K - JPY 10000K
- フィールドアプリケーションサイエンティスト バイオテクノロ... / JPY - Japanese Yen JPY 7000K - JPY 11000K
- RA Development Manager at Global Leading Pharma / JPY - Japanese Yen JPY 8000K - JPY 14000K
- Marketing Manager (Pharma, New launch!) / JPY - Japanese Yen JPY 12000K - JPY 16000K
You will now be redirected to an external site.
Please confirm each site’s terms of agreement (privacy policy) in regards to the management of personal information.
Recruiter
Michael Page International Japan K.K./マイケル・ペイジ・インターナショナル・ジャパン株式会社
