Executive Director, Regulatory Conformance

The Executive Director, Global Regulatory Affairs & Clinical Safety (GRACS)-CMC, Site CMC & Conformance is accountable for management of the global Site CMC Conformance organization and leading the site-based CMC resources and programs at 16+ global manufacturing sites. This includes providing support for site change control development/assessment, representing GRACS CMC on Site Change Review Boards and providing regulatory CMC input into inquiries. The Executive Director, GRACS CMC Conformance provides leadership and oversight to administer global CMC Conformance programs that maintain the accuracy of global CMC dossiers. The Executive Director is accountable for monitoring the current state of CMC regulatory systems/processes and working with manufacturing sites to deliver a sustainable level of regulatory conformance. The Executive Director, GRACS CMC Conformance is accountable for working cross-functionally across all modalities (biotherapeutics, pharmaceuticals and vaccines) in GRACS CMC and with manufacturing site personnel to facilitate the regulatory assessment of change control information and recommend regulatory actions that will enable sustained conformance of regulatory information. Responsibilities: Collaborate and build relationships with stakeholders at manufacturing sites and oversee Site CMC input to change control development/assessment, Site Change Review Boards and CMC-related inquiries. Develop creative and imaginative approaches to resolve problems, flexibly allocate resources and respond to changing priorities or unexpected events. Proactively identify and solve the most complex problems that may impact the management and direction of regulatory conformance practices. Collaborate with global stakeholders across multiple disciplines and multiple organizations to develop, adapt and execute regulatory conformance strategy. Manage project definition and resource requirements for optimization projects, as required. Represent GRACS CMC in senior leadership forums to report on regulatory conformance status, potential risks, business impact and mitigation strategies in a clear, concise and balanced manner.   Qualifications Education Requirement: Degree in pharmacy, chemistry, engineering or a related scientific discipline; post-graduate degree preferred. Required: Minimum 20 years pharmaceutical industry experience; 15 years with an advanced degree. Minimum 10 years working in Regulatory CMC, including experience with CMC change management processes and leadership of regulatory conformance programs. Minimum of 5 years managing people. The candidate must be proficient in English; additional language skills are a plus. The candidate will be required to travel on a periodic basis Recognized as a CMC expert with broad expertise in CMC/regulatory and change management activities across product development, registration and life-cycle management, as well experience in product development, manufacturing or quality control/quality assurance. Demonstrated ability to anticipate and influence internal/external business and regulatory environment to identify potential changes impacting business practices and proactively recommend process improvements to minimize compliance risk Thorough understanding of external business and global regulatory environment to enable proactive identification of evolving regulatory expectations that may have an impact on the company and regulatory conformance strategy. Detail oriented leader with strong leadership/people management skills and exceptional interpersonal, collaboration and communication skills. Demonstrated ability to interpret and apply diverse regulatory requirements to development of compliant regulatory processes that effectively balance regulatory expectations with business needs. Experience in leading Health Authority interactions and communication strategy development. Proven track record in working and influencing multi-disciplinary teams with demonstrated leadership, communication, innovative problem solving and rapid, disciplined decision making, critical thinking capabilities, and ability to work well under pressure. Exceptional interpersonal, verbal and written communication, presentation, and listening skills with a proven record of working with, and influencing, multi-disciplinary teams and external experts. Demonstrated experience in building, rewarding, developing and retaining key talent. Requisition ID: REG004009
Salary Range: NA
Minimum Qualification
15+ years

Don't Be Fooled

The fraudster will send a check to the victim who has accepted a job. The check can be for multiple reasons such as signing bonus, supplies, etc. The victim will be instructed to deposit the check and use the money for any of these reasons and then instructed to send the remaining funds to the fraudster. The check will bounce and the victim is left responsible.