JOB DESCRIPTION – primary duties and responsibilities
Provide regulatory leadership and oversight to a team of regulatory professionals across multiple global locations, and oversee CMC regulatory activities in support of post-approval lifecycle management for the Roche Biologics portfolio. Interact directly with senior management and senior-level officials from Health Authorities. Serve, at all times, to improve Roche's standing with Health Authorities.
Accountable for the quality of all Regulatory Submissions for Roche`s Biologics marketed portfolio as well as accountable for all interactions with global Health Authorities related to CMC aspects of the Biologics marketed portfolio.
Effectively lead the organization, which includes operating in compliance with the regulatory requirements, efficiently resourcing programs/projects, ensuring timely completion of projects, adhering to budget targets, and proactively developing and implementing continuous improvement solutions.
Foster employee development. Coach, mentor and develop staff by stretching team members, including taking challenging assignments. Expected to embody the Roche values and leadership commitments. Ensure staff obtain and consistently apply current, in-depth knowledge of Roche and global regulatory requirements, guidelines, procedures and best practices.
Fosters a culture of high performance, trust and collaboration. Builds and cultivates a strong network and strengthens partnerships to facilitate knowledge exchange and the sharing of best practices and lessons learned.
Represent Pharma Technical Regulatory at the governance bodies responsible for Roche`s Biologic marketed portfolio including Technical Regulatory Advisory Committee, Late Stage Technical Development Committee and Biologics Quality Council. Share responsibility of the Technical Regulatory Advisory Committee charter and adhere to the company Decision-Making principles.
As a member of the Pharma Technical Regulatory leadership team, work collaboratively and strategically to establish priorities and direction for the organization to meet its business needs, being innovative and efficient to achieve the company's long range goals. Contribute to the development of department business initiatives and facilitate their implementation.
Accountable to ensure effective working relationships with regulatory authorities across his/her relevant staff members. Ensure staff members provide internal teams with timely and appropriate direction on regulatory authority interactions.
Contribute to regulatory intelligence gathering and to the development of internal and cross- functional regulatory policy.
Provide senior-level internal review for regulatory submissions and other relevant regulatory documentation pertaining to projects across his/her staff as required.
At a minimum Bachelor in science disciplines plus relevant experience; Post Graduate Degree (Master or PhD) is a plus.
15+ years of experience in the core activities of Technical Operations, Quality and / or Regulatory; Post Graduate Degree qualifies for reduced years of experience
5+ years of leadership experience, experience in leading leaders and leading global teams
Demonstrated capabilities in PTR and Roche Core Competencies.
Lead by example in accordance with the Roche Values and Leadership Competencies.
Excellent track record in people management, including performance management and people development. Demonstrated ability to connect with and inspire staff at all levels.