Job Title: Regulatory Affairs Director
Location: Japan (Remote)
Our client is a global pharmaceutical company dedicated to improving global health through innovative pharmaceutical solutions. Their commitment to excellence and patient care drives them to develop and deliver high-quality medications. They are seeking a highly skilled and experienced Regulatory Affairs Director to join the team in Japan.
Job Description: As the Regulatory Affairs Director, you will play a pivotal role in ensuring our products meet all regulatory requirements and standards. You will lead the regulatory affairs team, develop regulatory strategies, and manage submissions to regulatory authorities. Your expertise will be crucial in navigating the complex regulatory landscape and ensuring the successful approval and compliance of our pharmaceutical products.
Key Responsibilities:
- Lead and manage the regulatory affairs team.
- Develop and implement regulatory strategies for product approvals.
- Prepare and submit regulatory documents to health authorities.
- Ensure compliance with local and international regulatory requirements.
- Liaise with regulatory agencies and represent the company in regulatory matters.
- Monitor and interpret regulatory changes and provide guidance to the team.
- Collaborate with cross-functional teams to support product development and commercialization.
- Provide regulatory expertise during audits and inspections.
Qualifications:
- Bachelor's degree in Pharmacy, Life Sciences, or a related field (advanced degree preferred).
- Minimum of 10 years of experience in regulatory affairs within the pharmaceutical industry.
- In-depth knowledge of Japanese and international regulatory requirements.
- Proven track record of successful regulatory submissions and approvals.
- Strong leadership and team management skills.
- Excellent communication and interpersonal skills.
- Ability to work effectively in a fast-paced and dynamic environment.
- Proficiency in both Japanese and English.
ไผ็คพๆฆ่ฆ: ็งใใกใฎใฏใฉใคใขใณใใฏใ้ฉๆฐ็ใชๅป่ฌๅใฝใชใฅใผใทใงใณใ้ใใฆไธ็ใฎๅฅๅบทใๆนๅใใใใจใซๅฐๅฟตใใฆใใใฐใญใผใใซใช่ฃฝ่ฌไผ็คพใงใใๅ่ถๆงใจๆฃ่ ใฑใขใธใฎใณใใใใกใณใใใ้ซๅ่ณชใชๅป่ฌๅใฎ้็บใจๆไพใๆจ้ฒใใฆใใพใใ็พๅจใๆฅๆฌใง่ฆๅถๆฅญๅใใฃใฌใฏใฟใผใจใใฆใใผใ ใซๅ ใใใ้ซๅบฆใชในใญใซใจ็ต้จใๆใคๆนใๅ้ใใฆใใพใใ
ไปไบๅ ๅฎน: ่ฆๅถๆฅญๅใใฃใฌใฏใฟใผใจใใฆใ่ฃฝๅใใในใฆใฎ่ฆๅถ่ฆไปถใจๅบๆบใๆบใใใใใซใใ้่ฆใชๅฝนๅฒใๆใใใพใใ่ฆๅถๆฅญๅใใผใ ใ็ใใ่ฆๅถๆฆ็ฅใ้็บใใ่ฆๅถๅฝๅฑใธใฎๆๅบใ็ฎก็ใใพใใ่ค้ใช่ฆๅถ็ฐๅขใใใใฒใผใใใๅป่ฌๅใฎๆฟ่ชใจใณใณใใฉใคใขใณในใ็ขบไฟใใใใใฎๅฐ้็ฅ่ญใๆฑใใใใพใใ
ไธปใช่ฒฌไปป:
- ่ฆๅถๆฅญๅใใผใ ใ็ใใฆ็ฎก็ใใใ
- ่ฃฝๅๆฟ่ชใฎใใใฎ่ฆๅถๆฆ็ฅใ้็บใใใณๅฎๆฝใใใ
- ่ฆๅถๅฝๅฑใธใฎ่ฆๅถๆๆธใๆบๅใๆๅบใใใ
- ๅฝๅ ใใใณๅฝ้็ใช่ฆๅถ่ฆไปถใ้ตๅฎใใใ
- ่ฆๅถๆฉ้ขใจ้ฃๆบใใ่ฆๅถใซ้ขใใไบ้ ใงไผ็คพใไปฃ่กจใใใ
- ่ฆๅถใฎๅคๆดใ็ฃ่ฆใ่งฃ้ใใใใผใ ใซๆๅฐใๆไพใใใ
- ่ฃฝๅ้็บใจๅๆฅญๅใๆฏๆดใใใใใซใใฏใญในใใกใณใฏใทใงใใซใใผใ ใจๅๅใใใ
- ็ฃๆปใใใณๆคๆปไธญใซ่ฆๅถใฎๅฐ้็ฅ่ญใๆไพใใใ
่ณๆ ผ:
- ่ฌๅญฆใ็ๅฝ็งๅญฆใใพใใฏ้ข้ฃๅ้ใฎๅญฆๅฃซๅท๏ผไธ็ดๅญฆไฝใๆใพใใ๏ผใ
- ่ฃฝ่ฌๆฅญ็ใงใฎ่ฆๅถๆฅญๅใซใใใๆไฝ10ๅนดใฎ็ต้จใ
- ๆฅๆฌใใใณๅฝ้็ใช่ฆๅถ่ฆไปถใซ้ขใใๆทฑใ็ฅ่ญใ
- ่ฆๅถๆๅบใใใณๆฟ่ชใฎๆๅๅฎ็ธพใ
- ๅผทๅใชใชใผใใผใทใใใจใใผใ ็ฎก็ในใญใซใ
- ๅชใใใณใใฅใใฑใผใทใงใณใใใณๅฏพไบบในใญใซใ
- ่ฟ ้ใงใใคใใใใฏใช็ฐๅขใงๅนๆ็ใซๅใ่ฝๅใ
- ๆฅๆฌ่ชใจ่ฑ่ชใฎไธกๆนใซๅ ช่ฝใงใใใใจใ
