医薬開発本部レギュラトリーアフェアーズジャパン開発薬事ノンラインマネージャー

大手外資製薬メーカーにて開発薬事業務を担っていただきます。

仕事内容

The manager of RRL JP provides strong leadership to develop and implement regulatory strategy for the assigned products/projects as RRL JP, and exercises activities which include:

・An integral member of the Regulatory Excellence Team, a contact point of Global Regulatory Lead (GRL), responsible for a particular therapeutic area(s), contributes to the delivery of robust regulatory strategies, leads task team for J-CTD, and coordinates local regulatory activities for the assigned development projects and marketed products for Japan to enable timely submissions and approvals.
・Interface & contact partner for the Japanese regulatory authorities for development products including those undergoing PMDA consultation as well as marketed products, Global RA and other cross functional stakeholders for product and project related regulatory activities for the assigned therapeutic area(s).
・Regulatory expert for the regulatory requirements in Japan.
・Support Head of Development RA regarding specific projects and activities..
・Act as Regional Regulatory Lead Japan for assigned products/projects and be a trusted partner to health authorities as well as .

Accountabilities
1. Regulatory Strategy and Registration Activities.
1.1 An integral member of the Regulatory Excellence Team, responsible for a particular therapeutic area(s) and contributes to the delivery of robust regulatory strategies and coordination of local regulatory activities for the assigned development projects and marketed products for Japan to enable timely submissions and approvals.
a. Actively participate in Regulatory Excellence Team meetings and discussions, providing GRL with Japanese regulatory advice and updates. Supports GRL with the local aspects for the generation of Regulatory Status Updates, management briefings (Product Update Reports) as well as pre-reads and presentation at the Regulatory Expert Group (REG).
b. Provide Japanese regulatory input and guidance on development needs such as the need for inclusion of special populations into clinical trials, required subgroup analyses and ensures local requirements and agreed strategy are addressed in the submissions including expedited regulatory pathways if available. Supports the GRL with the local aspects for the Global Regulatory Strategy document.
c. Identify, investigate and recommend solutions to potential regulatory challenges during product lifecycle including product defense & benefit / risk assessments.
d. Coordinate, plan and conduct formal / informal meetings and teleconferences with regulatory authorities in Japan in cooperation with GRL and relevant stakeholders as appropriate. This includes the lead of preparation of the relevant briefing packages in cooperation with GRL and required stakeholders.
e. Provide guidance and contribute to the strategy and content of local labels for original submissions and product lifecycle management as appropriate.
f. Deliver robust regulatory strategies for the Japanese regulatory documentation (e.g. Clinical Trial Notifications, pediatric development plans and applications, local dossier elements for Marketing Authorization Applications and life cycle management).
Generate and provide local regulatory documentation e.g. local regulatory statements in cooperation with GRO as appropriate.
g. Lead the provision of responses to local Health Authority questions from Japan. Contribute to response strategy in cooperation with GRL and other stakeholders. Submit responses to the Japanese health authority questions.
h. Lead task team for J-CTD and execute timely submissions to the Japanese regulatory authorities in accordance with the defined submission plans in collaboration with GRL, Regulatory Excellence Team and other stakeholders.

1.2 Interface & contact partner for the Japanese regulatory authorities for development products including those undergoing PMDA Consultation as well as marketed products, Global RA and other cross functional stakeholders for product and project related regulatory activities for the assigned therapeutic area(s):
a. Contact partner for GRA functions on regulatory requirements for Japan and their interpretation for product and project related regulatory activities for the assigned therapeutic area(s).
b. Ensure outcome of important agency meetings / regulatory procedures are communicated to GRL and other relevant stakeholders, as appropriate.
c. Provides regulatory input for Japan to Regional Clinical Development as appropriate and in alignment with the global regulator

1.3 Completion of new labeling for product launches, efficiently and accurately.

1.4 Act as member of Regulatory Excellence Team (RRL JP or LRL) for assigned products/projects, where applicable.

2. Regulatory Intelligence
2.1 Active contribution to evaluate relevant Japanese regulations and guidelines including drafts critically for company compliance to drug laws and determine impact on existing procedures.

2.2 Act as Subject Matter Expert for the regulatory requirements in product development in Japan

a. Provide information related to TA specific regulatory Intelligence for Japan.
b. Promote the knowledge of the regulatory landscape and regulatory requirements in Japan within the organization in collaboration with RET and any other relevant function as appropriate.
c. Provide support for Regulatory Intelligence Network process by compilation of Regulatory Intelligence Alert forms and impact assessments to ensure transparency and awareness with the organization on the magnitude of the impact for implementation.

3. Quality and Compliance
3.1 Adhere to /internal compliance rules.
3.2 Attend and contribute to GCP, PV, or other regulatory inspections.
3.3 Identify and assess topic affecting regulatory compliance.

4. External Relationships and Engagement
4.1 Pro-active contribution in local pharma network/trade association meetings and feedback on upcoming and current public consultations and position papers (where possible).

5. Training and Talent Management
5.1 Support Head of Development RA in training and talent management.

6. Involvement in Business Platforms
6.1 Actively participate and contribute to different business forums.

7. Lead/Engage in Cross-functional collaboration.
7.1 Be a valued partner to other functions in Human Pharma.
7.2 Provide input for Brand team strategy.

8. Managerial activities
8.1 Estimate budget planning for assigned projects.
8.2 Top-Management updates, including participation in decision making committees
8.3 Contribute to individual working groups upon special assignment.
8.4 Support Head of Development RA regarding specific projects and activities.

応募条件

【必須事項】

Bachelor or Master degree in Pharmacy, Chemistry, Biology, Biochemistry, Biotechnology, Technology or Agriculture with significant practical experience related to respective TA.
Further degrees, e.g. Specialized Pharmacist or Master of Drug Regulatory Affairs are appreciated

Knowledge:
・In depth knowledge of international regulatory requirements, including understanding, interpretation and application of the regulatory legislation in Japan.
・Excellent knowledge of and adherence to relevant internal processes and procedures.
・Good knowledge and understanding of the drug development process.
・Good knowledge and experience with drug development, marketing authorization. applications and maintenance of marketing authorizations
・Good understanding of chemical-pharmaceutical, medical subjects as well as of pharmacovigilance and labelling requirements.
・Well understanding of environment and trend of health authority.

Professional skills:
・Capable to provide the leadership to develop and implement solutions to complex problems.
・Unbiased international view and inter-cultural competence.
・Open minded, motivating personality with drive and initiative.
・Willingness and ability to create and share knowledge.
・Critical thinker with ability to self-manage workload, including reprioritizing and delivery under tight timelines.
・Ability to work well under pressure, influence without authority, good interpersonal and negotiation skills.
・Team player, flexible and willingness to adapt in a changing environment.
・Excellent oral and written communications skills.

Experience:
・More than 5 years’ experience in RA including new drug registration.
・More than 5 years’ experience in R&D and/or Medical development.
・Practical experience in handling new developments, registrations and maintenance of marketing authorizations.
・Experience with direct Health Authority interactions.
・Track record in filings of Clinical Trial Notifications, Marketing Authorization Applications (J-NDAs), Partial Change Applications (J-sNDA) or related regulatory applications.
・Preferably international work experience.

Language skills:
・Japanese: Fluent
・English: Fluent

【歓迎経験】

【免許・資格】

【勤務開始日】

応相談

学歴

大学卒以上

雇用形態

正社員

試用期間

3ヶ月

勤務地

東京

転勤の有無

転勤なし

受動喫煙防止措置

屋内禁煙

勤務時間

通常（実質労働時間との連動）
就業時間：00:00 ～ 00:00

勤務開始日

応相談

休日休暇

年間休日数：127
土日祝
年間有給休暇：入社直後4日　4日 ～ 13日
法定休暇：年次有給休暇、産前産後休暇
その他休暇：慶弔休暇・リフレッシュ休暇、整理休暇

年収・給与

年収　　800万円～1150万円　

諸手当

・当社規定により経験に応じて優遇
・外勤手当、時間外手当、MR手当

昇給

年1回(4月)

賞与

賞与 固定賞与（夏･冬　各2.5ヶ月）　および　業績賞与

採用人数

1名　

待遇・福利厚生

通勤手当：有
寮・社宅：有
福利厚生倶楽部、確定拠出年金（給与財源型/DC）と確定給付企業年金（リスク分担型/RSDB））、財形貯蓄、住宅取得補助手当制度（規定に準ずる）、医療費補助等

各種制度

健康保険：有
雇用保険：有
労災保険：有
厚生年金：有
退職金制度：有

選考プロセス

１）書類選考
２）一次面接
３）二次面接
４）最終面接