Global Senior Regulatory Affairs Manager Labelling - Hertfordshire, United Kingdom - Page Group

Page Group

Verified Company

Hertfordshire, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Excellent opportunity to lead, manage and implement global labelling processes for a well renowned global pharmaceutical business.

Client Details
I have partnered with a global leading research based pharmaceutical company who specialise in oncology and neurology. They offer flexible hybrid working and UK head office is based in Hertfordshire.

Due to continued success they are looking for a GlobalSenior Regulatory Affairs Manager Labelling to join the high performing team.

Description

Global Senior Regulatory Affairs Manager Labelling Responsibilities include:

To Maintain and Develop Product Labelling
To Act as a Labelling SME during crossfunctional team meetings
To Conduct crossfunctional team meeting
To Lead the Labeling Meetings and provide Labeling guidance
To conduct annual reviews for all CCDSs in line with the SOP for compliance
To support lifecycle management activities of the OBG and NBG for products covering, EU
To support the Global Labeling Process of CPI review and approval for initial National submissions and during assessment period which applies for MAA, variations and renewals for Americas and EMEA Growth Markets and RA Asia (and affiliates)

Profile
Global Senior Regulatory Affairs Manager Labelling

Bachelor's degree or higher in Life Sciences
Excellent written and spoken English
Experience in Regulatory, R&D or related area or equivalent experience within the pharmaceutical industry, and solid experience in labelling, specific with a strong scientific knowledge.
Demonstrates a solid working knowledge of drug development processes as well as US and EU labelling; knowledge of and experience with Asia and other markets labelling desirable.
Experience of European regulatory procedures (Centralised, MRP and DCP).
Proven interpersonal skills; negotiating, communicating, coaching & explaining.

Job Offer
Competitive Basic Salary

Car Allowance

Great Package