Ensure the development of appropriate regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy/ Integrated Asset Plan (IAP) to ensure the development program meets the needs of the key markets identified and the Medicine Profile. This goal has to be achieved while ensuring compliance with both internal company process / policy and with appropriate regulatory requirements to deliver the best possible labeling to meet the Medicine Profile, commensurate with the available data. Position may have direct reports.
Responsibilities and Accountabilities
To proactively develop a regulatory strategy focused on the key markets identified. In doing so, will promote innovative regulatory approaches when they benefit 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 organisation and in Health Authorities
Work alongside other core members of the MDT and/or EDT providing broad development input/expertise to their programs (over and above regulatory input).
If GRL, act as single point of accountability on the EDT/MDT, lead the Regulatory Matrix Team, and deliver the required Regulatory Work Package(s) associated with the IAP.
Capable of providing critical regulatory assessment as part of due diligence/business development activities
Experience, Skills and Specialized Knowledge Required
Bachelor 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 area or proven track record of being able to develop product / therapeutic knowledge in new area.
Proven experience of leading development, submission and approval activities including track record of organizing and executing successful milestone meetings and proven track record of 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 of leading regulatory activities outside local region.
Ideally, has established an external network into other pharmaceutical companies and recognized internally and externally as an expert broadly, or in specific areas, of regulatory affairs
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