Global Senior Regulatory Affairs Manager Labelling

1 month ago

Hertfordshire, United Kingdom Page Group Full time

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 cross-functional team meetings
- To Conduct cross-functional 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

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