Associate Director/Senior Director, Regulatory Affairs Strategy - Boston, Massachusetts, United States, 02298

The Associate Director/Director will be a strategic leader within Regulatory Affairs, responsible for developing and executing regulatory plans for assigned programs. As an expert within Regulatory, the Director will be relied on to articulate clear and compelling regulatory strategy, highlighting risks and opportunities when appropriate. Specifically, the Director will take accountability and ownership of all regulatory opportunities, plans, and deliverables for his or her assigned project(s). The Director may also oversee a therapeutic area with multiple projects.

Key Responsibilities:

* Serve as overall global regulatory lead accountable for all regulatory aspects of his or her assigned project(s), including development and implementation of the global regulatory development plan for the project Represent Global Regulatory Affairs (GRA) on cross-functional teams, including Project Development Teams
* Effectively communicate the regulatory strategy, risks, mitigations and overall plans to the GRA Management Team, Project Development Team and senior management, as relevant
* Ensure the global regulatory strategy for assigned project(s) is consistent with the business objectives and have been negotiated with relevant health authorities as appropriate
* Ensure alignment of regulatory strategy and plan on a continuous basis with the GRA Management Team and key cross-functional stakeholders
* Provide overall regulatory functional leadership to the GRA sub-team, including participating in the skill development, coaching, and performance feedback for members of the regulatory sub-team, regardless of formal reporting relationship May act as Regional Regulatory Program Lead in his or her base region, including leading all regional Health Authority interactions
* Monitor changes in the regulatory environment with potential strategic impact, working closely with the Head of Regulatory Policy May be responsible for line management and development of direct reports
* Identify areas in need of improvement and lead the development and implementation of process improvements
* Manage resources for assigned project(s), including ensuring adequate regulatory resources, skills, and budgets are available to deliver the project deliverables
* Capable of leading significant general projects for the function, including due diligence activities

Minimum Qualifications

* Minimum of Bachelor's degree in relevant scientific discipline, higher degree desirable
* A minimum 10 years Pharma experience, of which at least 10 years is in Regulatory Affairs
* Experience with developing and implementing competitive regulatory strategies
* Experience with line and matrix management
* Demonstrated track record in securing product approvals and maintaining a complex portfolio
* Experience dealing with broad range of stakeholders at all levels internal and external to the company
* Demonstrated competence in employee management and development
* Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance - preferably from at least both US and EU
* Direct experience of leading regulatory authority meetings in different phases of drug development
* Regulatory knowledge in a number of therapeutic areas