APAC Regional RA Director
職種 | 薬事申請 | 年収 | 1500-2000万円 |
雇用形態 | 正社員 | 日付 | 2010-04-14 |
地域 | その他 | 参照番号 | CBRET 2886019 |
(この求人は終了しました)
概要
Executive level RA role with regional responsibilities.
会社概要
Leading global medical device company. Very strong market share in a growing market.
職務内容
- Planning and execution of effective registration strategies for the Asian region aligned with the overall global RA strategy
- Set-up new ways for simplification and speed up of regulatory processes for the region where feasible
- Establish and maintain together with local direct RA reports close relationship with Health Authorities in the Asian region to support smooth regulatory processes
- Supervise and judge on effectiveness of involved regulatory agents used in countries with no RA employees together with Head of RA global
- Overlook and drive company involvement/commenting in new draft legislation of the region
- Ensure compliance with global and local regulation
- Cover registration activities for Australia/New Zealand in collaboration with agent
- Develop Asian regulatory intelligence network and exchange with HQ
- Execcute field corrective actions or recalls if necessary in collaboration with HQ QA and RA
- Supervise and perform vigilance activities, risk mitigation activities in collaboration with global line functions (clinical, QA) as needed
-Training of local RA persons and regional organisation
- Ensure close interrelationship with local regional sales and marketing department
- Review & provide buy-in to regional sales/marketing plans for new products, offer, LCM; advertising
応募条件
- Very good English language skills (written and spoken), fluent in one or more (preferable) Asian languages
BS or MS in medical/science/engineering
- Profound knowledge of legislative framework of region
- Experienced computer skill (basic SAP knowledge of advantage)
活かせる経験
- 7+ years experience in the regulatory field (device area (preferably) or pharmaceutical)
- Established negotiation experience with Asian Health Authorities
- Experience with several successful product registrations in Asian region
- Experience with medical device QMS of advantage
- Experience in vigilance activities
- BS or MS in medical/science/engineering
求める人物像
- Good motivator, good team player, experienced presentation skills, very good and open communicator, very good assertive negotiator
待遇・福利厚生
Social Insurance, Commutation Allowance
* Holidays: Paid Holidays
その他
APAC Regional RA Director
(この求人は終了しました)