PharmaLex is hiring a
Regulatory Affairs Hub Manager

Summary

Join Arbour Group, a leading global provider of digital compliance products and services for the life sciences industry, as a full-time Regulatory Affairs Hub Manager. This role involves preparing regulatory processes, communicating with project teams and health authorities, coordinating project teams, and managing regulatory affairs projects.

Requirements

• Graduate of any Health Science course
• At least 4 years of experience in corporate setting and pharmaceutical product exposure
• Leadership experience with direct reports

Responsibilities

• Preparation of regulatory processes to gain and maintain APAC and non-APAC marketing authorizations for human medicinal products (new marketing authorization application, renewal, variations, MAH transfer)
• Communication and interaction within the project team, with customers, local partners and health authorities in a regional and/or an international context
• Coordination and management of project teams with internal and external staff and global partners incl. reporting and oversight activities and responsibilities
• Responsible for the planning, filing and prosecution of Regulatory Affairs project
• Preparation and revision and compilation of the informative texts for healthcare professionals and patients (CCDS, SmPC, PIL, Labeling)
• Revision of approval documents including tracking of updates and respective handling of databases and document management systems
• Regulatory data and documents archiving handling in client databases and document management systems
• Variations, preparing post-approval change submissions like supplements/variations/amendments
• Renewals , Tracking and preparing renewal application, assessment of the supporting documents for renewal application submission
• Safety reports (PBRER/PSUR contributions, PSUSAs)
• Support license withdrawals
• Regulatory support for NDAs or out-licensing
• Response to deficiency letters/country requests, handling of HA queries with strategy and preparation of response packages
• Local labelling strategy
• Launch/deletion application assessments
• Processing of administrative documents
• Other LCM activities, as may be required

Benefits

• Work in a company with a solid track record of performance
• Have remote working arrangement and flexible working hours