Principal Regulatory Affairs Consultant (Oncology) - flexible location

We are looking for Regulatory Affairs Professionals on various levels (Senior and Principal Consultant) for a client dedicated project within Oncology. In this role, you will ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy /Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicines Profile. This goal has to be achieved while ensuring compliance with both internal process / policy and with appropriate regulatory requirements to deliver the best possible labeling to meet the Medicine Profile, commensurate with the available data.

Responsibilities and Accountabilities Proactively developing regulatory strategy that will deliver the needs of the local region(s), taking in to account the needs of other regions globally. Implementation of the regional strategy(s) in support of the project globally Lead regulatory interactions and the review processes in local region Ensuring appropriate interaction with global/regional counterparts and commercial teams in local region Ensuring compliance with global/ regional requirements at all stages of product life Ideally assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the region and the impact this will have on the regulatory strategy for an asset QualificationsExperience and Skills required for the role: Bachelor degree or preferably PhD in biological or healthcare science Experience in Oncology preferred, k nowledge of the therapy area, and ability to further develop necessary specialist knowledge for the product or area of medicine Experience of all phases of the drug development process in regulatory affairs preferred Capable of leading regional development, submission and approval activities in local region(s) Knowledge of clinical trial and licensing requirements in all major countries in the region and ideally knowledge of other key Agency processes globally. Good communication skills, especially in writing. Capable of delivering key communications with clarity, impact, and passion Ability to foster strong matrix working. Facilitates dialogue between team and matrix members to contribute their ideas. Capable of developing and recommending strategies for change. Capable of identifying project or team issues in advance and seeking necessary help and support to resolve. Ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions.