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Regulatory CMC Manager

年収:800万 ~ 1100万

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部署・役職名 Regulatory CMC Manager
職種
業種
勤務地
仕事内容 Mission Statements:

The incumbent regulatory professional is accountable for Japan strategic management of a portfolio of development projects within Global regulatory CMC & Devices (CMC&D) Japan. The incumbent is responsible for Japan regulatory CMC strategies, submission dossiers and approvals, including direct contact/liaison with PMDA/MHLW, for development phase of projects. The incumbent creates collaborative working relationships with Global Regulatory CMC&D Focal Points (FP), Japan Regulatory Group, Technical and Quality Groups within R&D and Industrial Affairs (IA), Regulatory Health Authorities, Others.

Duties & Responsibilities:

Develops innovative Japan regulatory CMC strategies and risk assessments for development projects in collaboration with Global Regulatory CMC&D FP. Assures that positive and collaborative relationships are developed with CMC teams to achieve the implementation of appropriate regulatory strategies. Assures that, for major CMC activities that have a critical regulatory and/or financial impact, appropriate strategies are developed to manage the activities, and risks are identified, communicated and mitigated as necessary.

Assures that appropriate contacts with Health Authorities (PMDA/MHLW), in collaboration with Japan regulatory group , are initiated and addressed in an effective and timely manner, whilst developing positive and favorable relationships. Responsible for direct contact/liaison with PMDA on specific CMC topics. Led PMDA quality consultations and other CMC focused regulatory meetings in collaboration with Global regulatory CMC&D FP and other R&D/IA CMC functions. Manages and directly contributes to HA meeting briefing documents in collaboration with global regulatory CMC FP, Global CMC Dossier, and other related CMC functions. Supports strategic negotiations with Japanese Health Authorities.

Manages post-marketed CMC change controls for the assigned product(s). Conducts regulatory impact assessment in timely manner, and provide Japan regulatory strategy for these changes that requires regulatory actions. In close collaboration with Japan post-marketed regulatory group, utilizes HA meetings/consultations as appropriate to develop suitable regulatory strategy that meet current local regulatory expectations as well as business needs. Collaborate closely with global/local IA functions and Japan post-marketed regulatory group to prepare dossier package suitable for regulatory submissions. Manages and directly contributes to the
CMC responses to regulatory inquiries in collaboration with Global regulatory CMC&D FP and IA site SMEs.

Manages and directly contributes to the CMC writing, preparation, review and approval of regulatory CMC dossiers for submission in collaboration with global CMC Dossier, Industrial Affairs Functions and GRA Regulatory Operations. Explores opportunity for efficiency improvement in the dossier preparation process and takes actions to promote new ideas. Assures that submission dossiers meet appropriate quality standards; strategies and mitigated risks are developed and communicated, and deadlines are achieved. Assures that technical and regulatory CMC issues are appropriately resolved with optimal solutions. Manages and directly contributes to the CMC responses to regulatory inquiries in collaboration with Global regulatory CMC&D FP and Japan regulatory group as well as global CMC Dossier and other CMC SME functions. As requested by IA/R&D quality organization, may support the regulatory inspection process (PAI) for development projects as a local GMP sub team lead.
労働条件 ■勤務時間
事業場外労働時間制
1日のみなし時間 7時間45分
勤務時間帯(目安) 8:45~17:30

■給与
経験・前職の給与レンジを参考として提示します。
※別途住宅手当もしくは社宅適用 (規定による)

■待遇 福利厚生
【試用期間】3カ月 / 労働条件は本採用と同じです。
【保険制度】
・健康保険
・厚生年金
・雇用保険
・労働災害補償保険(労災)

昇給年1回
賞与年3回(規定による)
通勤手当/社用車貸与(規定による)
MR手当
共済会
日当
社宅制度/住宅手当(規定による)
退職年金制度
財形貯蓄
福利厚生倶楽部他
完全週休2日制(土日)、祝日

■休日 休暇
【年間休日】125日
【有給休暇】11日~20日
年末年始(12/29-1/4),
5月1日
フレキシブル休暇2日
年次有給休暇(初年度11日/2年目以降付与日数増加、6年目以降毎年20日)
慶弔休暇
産前産後休暇
ラ・メゾン休暇など

■勤務地
ご希望をお伺いし出来るだけ考慮させていただく予定です。

オフィス内完全禁煙
*別途喫煙コーナーあり
応募資格

【必須(MUST)】

Knowledge, Skills & Competencies:

Global operational experience with a mid/large-size Regulatory CMC and Devices Organization. Knowledge of Japan & global regulations/guidelines, key Health Authority/Industry thinking and trends, and be capable of resolving strategic technical and regulatory issues. Knowledge of Japan regulatory dossier requirements and dossier preparation experience. Should demonstrate initiative, some independent thinking, anticipatory foresight, and be able to communicate effectively to internal and external audiences. Native level Japanese fluency (oral and written) and business level of English fluency (oral and written) is essential.

【歓迎(WANT)】

Qualifications:

Minimum of a Bachelor’s Degree; advanced degree (Masters, PhD) in a science/health field (eg, Analytical, Chemistry, Pharmacy, Biological/Biotechnology Sciences etc.), or equivalent, is desirable.

Technical pharmaceutical CMC experience (laboratory, manufacturing, etc.) is desirable. Typically, an additional minimum 3 years of direct Regulatory CMC experience is preferred. However more than 5 years may be applicable for certain associates within an individual contributor career path. Experience working for a Regulatory Health Authority is helpful but not essential.

アピールポイント 自社サービス・製品あり 外資系企業 女性管理職実績あり 従業員数1000人以上 シェアトップクラス 年間休日120日以上 産休・育休取得実績あり 教育・研修制度充実 Uターン・Iターン歓迎 マネジメント業務なし 完全土日休み フレックスタイム
更新日 2022/01/20
求人番号 2031407

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