Director of Global Regulatory Affairs, Global Oncology Lead

Hydrogen International Ltd
US$180k.00 - US$225k.00 pa + 25% bonus, relocation
21 Apr 2017
21 May 2017
Contract Type
Full Time
Director of Global Regulatory Affairs, Oncology - Cambridge, MA, USA

N.B. Applicants must have the right to work in the United States

This is a fantastic opportunity to assume a leadership role and become a key player in steering the regulatory direction for a very strong pipeline and portfolio of oncology products, in a world-leading pharmaceutical organisation.

Key responsibilities:

* Set the global regulatory development strategy for a portfolio of oncology products. Lead the global regulatory team in setting the global development and lifecycle management strategy, and create submission plans, and ensure they are executed according to plan.
* Provide oversight to ensure regulatory compliance of marketed products.
* Responsible for ensuring that regulatory submissions and approvals are achieved on schedule within regions of responsibility.
* Act as primary point of contact with regulatory authorities for products of responsibility.
* Maintain up to date knowledge of regulatory landscape relevant to products and regions of responsibility; conduct regulatory intelligence.
* Identifies and proposes solutions to the management of resource gaps for areas of responsibility.

Key requirements:

* Bachelor's degree or equivalent in science or healthcare; advanced degree preferred.
* 10+ years' regulatory affairs experience, to include leadership positions.
* Proven success in leading major regulatory filings and devising regulatory and/or development strategies for submissions to the FDA and EMA/Europe; experience with submissions in Emerging Markets is a plus.
* Experience leading lifecycle maintenance of oncology products, from pre-clinical through to Phase 3, and post-marketing.
* Experience of direct interactions (face-to-face meetings, responses to queries etc.) with regulatory authorities including FDA and EMA; interactions with other global regulatory agencies highly desirable.
* Strong understanding of global regulatory requirements and upcoming changes in the global regulatory landscape. Proactively identifies potential regulatory issues; offers creative solutions, including risk mitigation strategies.
* Ability to communicate complex scientific issues in oral and written form; can communicate with stakeholders (internal and external) at all levels.
* Experience of line management, as well as developing skills of team members is a plus.