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Regulatory Affairs Manager – Contract
iNova Pharmaceuticals. Lead and manage regulatory, medical affairs and quality-related activities for Singapore .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory compliance and quality management within the pharmaceutical industry, particularly in Singapore. Proficient in managing regulatory submissions, product registrations, and ensuring adherence to GxP standards while effectively collaborating with cross-functional teams.
Highest-signal resume keywords
Regulatory Compliance ManagementPharmaceutical Industry ExperienceProject Management SkillsTechnical Writing CapabilitiesSingapore Pharmacist Licence
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 SubmissionsProduct RegistrationsQuality ManagementPharmacovigilance ReportingGxP ComplianceAdvertisement RegulationsSales Promotion RegulationsDocument ManagementArtwork Review in VeevaAdverse-Event Reporting
Soft Skills
Interpersonal SkillsCommunication SkillsAttention to DetailOrganizational SkillsTeam Collaboration
Tools & Technologies
VeevaRegulatory TrackersDocument RepositoriesHSA Database
Certifications & Qualifications
Bachelor’s Degree in PharmacyCurrent Singapore Pharmacist Licence
Industry Keywords
Regulatory AffairsQuality AssurancePharmaceutical RegulationsHealth SupplementsCosmetic RegulationsMedical Device RegulationsFood Product RegulationGxP StandardsInternal AuditsMock Recalls
About the role
Key responsibilities & impact- Lead and manage regulatory, medical affairs and quality-related activities for Singapore
- Ensure full regulatory compliance for Singapore
- Partner with Country leadership and Regional/Group Regulatory Affairs
- Deliver compliant regulatory submissions
- Support promotional and medical compliance activities
- Coordinate quality/GxP interfaces with regional QA and Supply Chain functions
- Manage product registrations, variations, notifications and renewals in Singapore and Brunei
- Manage advertisement and sales promotion permit submissions
- Review and approve artwork in Veeva and coordinate implementation with Supply Chain and Commercial
- Maintain product licences, regulatory trackers and document repositories
- Manage CPP and FSC applications
- Manage queries from the Brunei third-party distributor
- Review and approve promotional materials and external communications
- Manage pharmacovigilance reporting and compile quarterly adverse-event reports from the HSA database
- Ensure GDP compliance for therapeutic-products wholesaler and importer licences
- Participate in internal audits and conduct mock recalls
- Manage product redressing through a third-party distributor
- Oversee product complaints and returns in Singapore and support Commercial Quality
Requirements
What you’ll need- Bachelor’s degree in Pharmacy
- Minimum 5 years pharmaceutical industry experience
- Experienced with the regulatory environment in Singapore
- Understanding of Singapore advertisement and sales promotion regulations and controls
- Familiarity with traditional medicines, health supplement, cosmetic, medical device and food product regulation is a bonus
- Strong project management and organisational skills
- High attention to detail and accuracy
- Demonstrated interpersonal skills
- Demonstrated communication skills (both oral and written)
- Technical writing capabilities preferred
- Able to interact with internal and external stakeholders professionally
- Able to work independently and actively participate as a team member
- Current Singapore pharmacist licence/registration is preferable
- Post-graduate qualification is desirable
Benefits
Comp & perks- 6-month maternity cover contract