Pharmaceuticals, Quality/Risk Management, Research & Development, Submission & Registration
4 Year Degree
Associate Group Director, Regulatory Program Management
Location: Mississauga, Ontario, Canada
If you’re a high-energy, ambitious leader in a regulatory profession with program management background, we want to speak with you. At Roche, we keep it simple – we are doing now what patients need next!
We are actively seeking talent for our global Regulatory division (PDR). In the position of Associate Group Director, you will be accountable for regional line management and regulatory leadership of a group of Regulatory Professionals.
Line management responsibilities for US/EU Partners and ERLs. Drives a culture of excellence and motivates employees to perform at their highest ability. Mentors PDR personnel within a region, and are responsible for employee’s objectives, performance and development
Responsible for resource allocation, knowledge sharing processes, people development, setting priorities, and identifying training needs,
Drives a culture of excellence for employees to perform at their highest ability
Provides guidance, input and strategic regulatory direction and mentorship on projects, risk assessments, critical issue management, regulatory submissions and related communication in a coaching and a training capacity
Maintains and leverages working relationships with local and global regulatory functions and other stakeholders
Identifies business opportunities and acts as a change agent and role model within PDR by modelling best practices
Serves as part of leadership, management and contribution to peer reviews and other relevant committees
Qualified candidates are encouraged to apply by: May 22, 2019
This position is not eligible for relocation support.
This position is open to applicants legally authorized to work in Canada.
Roche is an equal opportunity employer and prohibits unlawful discrimination based upon any legally protected ground. Roche will make a good faith effort to accommodate the individual needs of applicants with disabilities in our recruitment process.
NOTE: All employment is conditional upon completing and obtaining a satisfactory background check, including educational, employment, references and criminal records (for which a pardon has not been granted) checks.
University degree, preferably in a scientific/ technical discipline
Demonstrated regional leadership role
Excellent knowledge of regional regulatory processes with at least 10 years of relevant experience
Demonstrated expertise in leading/delivering global and/or regional filings, reviews and approvals of major submissions to Health Authorities such as original CTA/MAA
RAPS designation is highly desired
Experience, Skills, Knowledge:
Demonstrated excellence in the core competency areas of leadership, influence management, change management, customer focus/business focus, innovative/creative thinking, job knowledge, interpersonal/communication skills, global teamwork, coaching/mentoring. Specific examples of behaviors supporting these competencies include:
Demonstrates capability to obtain win-win situations in a matrix management organization through influence management skills, persuasion and networking.
Demonstrates deep functional knowledge and stays current in the field
Integrates functional expertise with business knowledge to solve problems and make good decisions for the overall business
Proactively shares expertise with other areas of the company to impact their business issues
Builds a work environment that promotes innovation and calculated risk taking
Motivates staff and others to challenge the status quo and look for opportunities to innovate
Plans and executes changes with agility
Takes action to improve processes and critiques processes and metrics for current performance and for scaling the business
Generates new ideas and diverse approaches
Rewards and recognizes employees and takes a long term view and makes plans for acquiring the skills and expertise needed to support the business today and in the future
Additional Salary Information: Director level salary
Internal Number: 201905-113488
About Roche Canada
Why Work for Roche?
Every day we help improve the health and quality of life of Canadians. Our corporate culture, characterized by the values of integrity, courage and passion, helps to make us the leader in the Canadian pharmaceutical and in vitro diagnostics market.
At Roche, we have developed a culture where we encourage our employees to do now what patients need next.
We provide innovative high-quality products and services; go above and beyond the normal course of business to delight our customers and build valued, long-term relationships; provide a high-performing, rewarding and supportive work environment where people want to grow; and demonstrate ethical and socially responsible behaviors.
Roche has three values: integrity, courage and passion. These values, which represent the Roche Group as well as our Canadian entity, describe the expected behaviors, the attitude and the way we should interact with our customers and colleagues. These values are the foundation of our identity.