Regulatory Affairs Hub Manager

3 days ago

Apply Now

Receive Emails with Similar Jobs

PharmaLex

WebsiteLinkedInAll Job Openings

Regulatory Affairs • Pharmacovigilance • Regulatory Operations • Pharmaceutical Quality • Audit / Inspection Preparation

1001 - 5000

Description

• Preparation of regulatory processes for marketing authorizations • Communication with project team and health authorities • Coordination of project teams and oversight activities • Planning and filing of Regulatory Affairs projects • Preparation of informative texts for healthcare professionals and patients • Revision of approval documents • Archiving of regulatory data in databases • Tracking and preparing renewal applications and safety reports • Regulatory support for NDAs or out-licensing

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

Benefits

• 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