Global Regulatory Affair Leader

Job Description

The role has the following responsibilities:

Manage a team of regulatory professionals on strategy development and implementation in support of licensing and life cycle management activities. Act as, or manage, the single point of Regulatory contact for Project Teams (PTs) and/or Vaccine Leadership Teams (VLTs), as appropriate, plus other internal project related teams (e.g. LTT, SRT etc.) and possibly teams with the rest of GSK corporation; Participate to project discussions and provide strategic, scientific and RA input. Develop the asset specific regulatory strategy on a global scale Global Regulatory Plan (GRP) ownership and accountability; Coordinate the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities Ensure that the content of product/portfolio specific regulatory documents is in line with GSK Vaccines (or corporate) objectives

Qualifications

Candidates must have RECENT and relevant experience in vaccine, biologics, anti-viral, or anti-infectious

• Must have experience with FDA

• Must have full life-cycle of product experience

• Must have managerial experience

• Advanced Scientific Degree

General Science or Life Science Degree 8+ years significant experience in managing regulatory projects, or appropriate experience.

Experience Level: At least 10 years of experience in regulatory affairs

Location: Must be willing to work out of Rockville, Maryland location

Additional Information

All your information will be kept confidential according to EEO guidelines.