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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory affairs within the pharmaceutical industry, ensuring compliance with local regulations and managing submissions for licenses and certifications. Proficient in collaboration with cross-functional teams and providing regulatory support while maintaining high standards of integrity and organization.
Highest-signal resume keywords
Regulatory Affairs ExperienceQualified Pharmacist LicensePharmaceutical Compliance KnowledgeProject Management SkillsBilingual in English and Chinese
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory Submission PreparationPharmaceutical Product License RegistrationGMP ComplianceGDP CompliancePharmacovigilance Support
Soft Skills
Interpersonal SkillsCommunication SkillsTeam PlayerDetail-MindedOrganizational Skills
Tools & Technologies
Regulatory Compliance SoftwareDocument Management Systems
Certifications & Qualifications
Bachelor’s Degree in PharmacyQualified Pharmacist License
Industry Keywords
Pharmaceutical IndustryMedical Device IndustryHealth Care IndustryLocal Regulatory EnvironmentPIC/S GMP
About the role
Key responsibilities & impact- Managing Taiwan Pharmaceutical related certificates and licenses for MedSurg businesses to ensure regulatory compliance in Taiwan.
- Preparing regulatory submission documents to authority for pharma. GDP, pharma. PIC/S GMP and pharma. product license registration and maintenance.
- Submitting documents to health authorities and monitoring the progress of registrations.
- Responding authority request and authority enquiries for license application and maintenance; and pharma. GMP/GDP related inspections.
- Collaborating with global and cross-functional team to manage open requests and deficiencies.
- Provide regulatory support to cross functions.
- support pharmacovigilance-related activities
Requirements
What you’ll need- Bachelor’s Degree holder in Pharmacy, Science, Engineering or any health care-related discipline.
- At least 5 year of experience in regulatory affairs role in pharmaceutical, medical device or health care industry.
- qualified pharmacist license
- Sound knowledge of local regulatory environment and regulations.
- Good command of both written and spoken English and Chinese.
- Excellent computer literacy, good interpersonal, communication and project management skills.
- Team player with high degree of integrity and responsibility. Organized, detail-minded and flexible.
Benefits
Comp & perks- Solventum offers many programs to help you live your best life – both physically and financially.
- Solventum regularly benchmarks with other companies that are comparable in size and scope.
- Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process.
