Director, BD Regulatory Affairs

Job Description

The Director, BD Regulatory Affairs is responsible for strategic and tactical functional support for business development projects. This important role will be a key partner to the global BD team, ensuring that the function’s perspective is embedded in diligence and integration efforts.

Job Duties

* Serve as the global liaison between RA and the BD team.

* Responsible for providing in-depth analysis of Medical Device/Healthcare quality management system functionality and maintenance to contribute to transfer of business activities.

* Provide strategic guidance on global regulatory pathways and market access planning.

* Accountable for developing, maintaining, and executing a RA M&A readiness plan. Assess current capabilities, systems, policies, processes, organizational structure, and resources for conducting RA due diligence, integration strategy/planning activities, and integration execution against best practices. Tool & Process Development and Continuous Improvement: Create the tools and standard operating processes necessary to support RA efforts throughout the full business development cycle (pre deal through integration), including ownership of assigned deliverables. Develop a clear implementation plan, agreed to by BD and RA senior leaders.

* Resource planning and intra-RA coordination: maintain an up-to-date view of all projects in the business development pipeline. Plan for functional support by estimating timing and resource requirements per project. Communicate and coordinate needs within the function to identify and obtain adequate support at global and regional levels.

* Ensure the appropriate global regulatory requirements, are considered as part of due diligence and appropriately incorporated into integration activities.

* Accountable for ensuring all regulatory documentation is maintained, well-organized and ready to be audited by global regulatory authorities / notified bodies.

* Develop an understanding of business unit strategies and product portfolios. Provide Business Unit Leaders and other key stakeholders regulatory guidance strategy to assist in BD decision making, integration strategy/planning, and execution.

* Build and maintain a network of resources in all regions, across all businesses and divisions.

* Functional and Regional Alignment: coordinate with global and regional RA teams to ensure efforts are aligned, obtain approvals, and assign resources.

* Take responsibility for all RA aspects of each business development project by a) conducting or overseeing due diligence and integration activities, b) building a functional plan for each project to ensure that functional risks are identified, and actions are planned, and c) securing necessary approvals from RA/regional leadership for due diligence reports and integration strategy/plans.

* Stay current on industry and functional trends by reviewing the output of relevant regulatory intelligence reports and apply learning to target evaluation and integration. Training & coaching: Develop personal expertise and train RA personnel on BD tools & processes. Coach colleagues on how to effectively participate in due diligence and integration planning and execution.

Job Requirements

REQUIRED QUALIFICATIONS:

* Bachelor’s degree in a science-related discipline; Masters preferred.

* Minimum of 15 year of directly related Regulatory Affairs experience; preferably at least 10 years in a global role.

* Excellent understanding of the typical functional roles and responsibilities in R&D.

* Practical understanding of global regulatory/quality standards and requirements.

* Potential for travel up to 20% (deal-needs dependent); domestic and international.

PREFERRED QUALIFICATIONS:

* Experience with global submissions and determining regulatory pathways.

* Knowledge of and experience managing a Quality Management System and leading external QMS certification/surveillance audits.

* Thorough understanding of global submission requirements and appropriate design control requirements in order to satisfy global Health Authority submission standards.

* In-depth knowledge of global quality and regulatory requirements for the development of new product and maintenance support for sustaining market access.

* Experience in Business Development/M&A projects.

* Demonstrated ability to lead programs/projects. Has sense of passion, drive and perseverance to accomplish goals. Excellent team player.

* Global understanding of product domains and key technology/therapeutic area/R&D disciplines

* Excellent ability to read and influence senior decision makers bridging organizational complexities

* Strong project management skills, including planning, budgeting, and resource management.

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