Regulatory Affairs Hub Manager

Arbour Group (a Cencora PharmaLex company) one of the leading global providers of digital compliance products and services for the life sciences industry, is looking for a full-time Regulatory Affairs Hub Manager who will be responsible for the following tasks:  

• 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

Minimum Qualifications:

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

What's on Offer?

• Work in a company with a solid track record of performance
• Have remote working arrangement and flexible working hours
• Have the opportunity to work with a diverse multi-functional team and collaborate with different industry experts and SMEs internationally

Don't miss this amazing opportunity to work with a dynamic team of professionals while enhancing your career in the life sciences industry. Apply Now!

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law.