Head of Regulatory Compliance and Centralization

1 month ago

Mississauga Ontario CW, Peel region, Canada F. Hoffmann-La Roche Gruppe Full time

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.


The Position


A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.


As the Head of Pharma Technical Regulatory (PTR) Compliance and Centralization you will lead a global organization responsible for ensuring regulatory compliance and effective issue management across all Chemistry, Manufacturing and Controls (CMC) activities. In this role you will have strategic oversight, people leadership and the implementation of continuous improvement initiatives to enhance efficiency and compliance with global health authority requirements. As a people leader, you will work in a highly matrixed environment, collaborating with cross-functional teams to centralize work processes while maintaining the highest standards of regulatory compliance.


As a leader you will lead regulatory compliance initiatives and strategies, define associated critical steps and resources needed and take ownership for implementation of these initiatives and strategies. Additionally, you will drive efforts to improve harmonies and efficiencies in core regulatory processes such as Annual Reports and Change Control, as well as identify future opportunities for the global organization. This role is responsible to the Pharma Technical Regulatory Leadership Team (PTRLT) for development and monitoring of key performance metrics for the organization to optimize organizational performance on core regulatory processes.


The Opportunity:


You will develop and implement processes and tools to ensure PTR’s ability to maintain a state of regulatory compliance in all aspects across all technology platforms.


You will partner across functions to advise the monitoring of regulatory commitments made to Health Authorities and ensure commitments are being fulfilled on schedule while aiming for continuous improvements in the management of the tracking and delivery. You will also be the primary contact for issue management internally and strategically collaborate with PTQ, PDR, and other functions to streamline process and clarify decision making.


You will identify and champion continuous improvement initiatives focused on enhancing regulatory processes and systems, ensuring they are robust, efficient and compliant. Identify and drive strategies to optimize PTR work processes across the organization with new and innovative approaches to core regulatory work in collaboration with PTRLT.


You will work across the PTR organization to ensure seamless integration of key regulatory work processes that drive efficiency through centralization including change control and annual reports. In addition, you will establish and supervise key performance indicators (KPIs) to measure the effectiveness of compliance initiatives and drive data-informed decision-making.


As a people leader you will be responsible for managing a team of 5-7 regulatory professionals, which includes setting performance objectives, providing timely feedback and ensuring alignment of short-term development goals with longer-term career goals.


You will be a part of the PTR leadership team and accountable for regulatory excellence and compliance across the global organization requiring leadership experience and skills.


Who you are


You will have a Postgraduate Degree in life science disciplines with 15 or more years work experience in the pharmaceutical, biotechnology or related industry including significant experience in Regulatory CMC/Compliance and Quality.


You will have validated knowledge of relevant global Health Authority guidelines and regulations, interactions and regulatory dossier requirements.


You will have technical understanding of drug substance and product manufacturing, as well as biotechnology and product development processes. Expert knowledge of drug development, commercialization process, supply chain complexity and Pharmaceutical Quality Systems and multidisciplinary functions involved in drug development (all functions), manufacturing, commercialization and product lifecycle management.


You will be experienced in collaborating with technical (quality) regulatory interfaces with stakeholders such as Technical Functions, Quality, Operations, Program Management, Supply Chain and Product Development besides the collaborations with platforms within PTR.


You will possess strategic agility and proficiency in business tools, project management and risk-management principles. Work towards continuous improvements and operate with a lean approach.


You will have a proven track record of team leadership, preferably cross-functional teams, including leading teams through different stages of product development and/or life-cycle management. Previous people management or cross-functional team leadership experience is required along with developing people through ongoing coaching, mentoring and stretch assignments.


You will have exceptional influencing and negotiation skills, extracts optimized business results through resourceful collaboration with others (at all levels and across organizations) without formal authority and is highly adept at identifying solutions that will balance the needs of all parties involved.


Preferred:


Master’s Degree in life science disciplines is strongly preferred.


Travel Requirements:


Ability to travel according to the needs of the position; domestic and international travel.


Who we are


At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.


Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche's truly innovative culture.


As of January 4, 2022, Roche requires all new employees who work in Canada to be fully vaccinated against COVID-19 on the date they take office. This requirement is a condition of employment at Roche that applies regardless of whether the position is on a Roche campus or remotely. If you have a valid reason for not being fully immunized, which is limited to certain specific medical reasons or other valid reasons protected by applicable human rights laws, you may request an exemption and/or adaptation measures regarding this vaccination requirement.


Roche is an Equal Opportunity Employer.

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