Senior Regulatory Affairs Consultant-Global Regulatory Lead

We have a compelling opportunity for a Regulatory professional with expertise in clinical RA strategy . He/she will operate mainly to support global submissions, including the US. This role is to support one of our reputable clients exclusively.

This role can be based in several European countries and is available on different seniority levels. We also encourage ex-scientific writers to apply.

In this role, you will be responsible for: Proactively developing a regulatory strategy focused on the key markets identified. In doing so, will promote innovative regulatory approaches when they benefit the advancement of a given program. Ensure implementation of the regulatory strategy(s) in support of the project priorities. Assess precedent, regulatory intelligence, and competitive environment from a regulatory perspective and the impact this will have on the regulatory strategy for an asset. Lead regulatory interactions and the regulatory review processes Ensure effective interaction with local regulatory counterparts in priority markets and global commercial teams Ensure compliance with regulatory requirements at all stages of product life Advocate persuasively to senior leaders in the company and in Health Authorities Capable of providing critical regulatory assessment as part of due diligence/business development activities QualificationsBachelor degree or preferably PhD in biological or healthcare science Extensive experience of all phases of the drug development process in regulatory affairs, including for projects with little or no precedence. Extensive knowledge of relevant therapeutic areas or proven track record of being able to develop product / therapeutic knowledge in a new area. Proven experience of leading development, submission, and approval activities including a track record of organizing and executing successful milestone meetings and proven track record of a successful relationship with one or more Health Authority Extensive knowledge of clinical trial and licensing requirements in priority markets and sound knowledge globally. Ideally, proven experience in leading regulatory activities outside the local region. Ideally, has established an external network with other pharmaceutical companies and recognized internally and externally as an expert broadly, or in specific areas, of regulatory affairs.