Regulatory Affairs support

Increase the font size  Reduce the font size 2022-09-26 IP Location 菲律宾 312
Industry Category Healthcare Position Pharmacy
Recruitment Department Number Of Recruits several
Work Location Metro Manila (NCR) Taguig Nature Of Work Full Time
Gender Requirements Male Marriage Requirement No marital status restrictions
Education Level Bachelor's Degree Work Experience No work experience restrictions
Age Requirement Above 18 years old Salary Package 30000-35000 PHP / Monthly
Updated Date 2022-09-26 Valid Until Valid for a long time
Job Description
Responsible for regulatory planning for new product introductions and product changes and assist in maintaining regulatory compliance.Plan, generate and coordinate regulatory submissions for product/ solution licensingMaintain existing regulatory filings/ licenses, managing updates and related changes control processes.Assists with implementation of global regulatory and roadmaps through understanding the competitive market landscape and product marketing strategy.Develop regulatory strategy and if needed connect to regulatory SME's and make regulatory planProactive stakeholder management with business/ manufacturerDevelops and facilitates regulatory submissions for new products/ solution, existing products/ solutionsOther regulatory projects as applicable.1-2 years of experience in the medical device industryAbility to understand regulatory environmentAbility to understand compliance rules, guidelines and regulationsAbility to partner with other areas of the companyExperience in assembling the technical documentAbility to interpret applicable regulations to ensure compliance in a changing regulatory landscapeAbility to work in a matrix organization and being agileStrong organizational skills, ability to work on multiple projects and work effectively in a demanding time sensitive environment
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