One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since its founding in 1981, the company has introduced breakthrough treatments that have provided new hope for patients. The company's areas of focus are rare genetic diseases, multiple sclerosis, cardiovascular disease, and endocrinology. Genzyme is a Sanofi company. Genzyme's press releases and other company information are available at www.genzyme.com.
The Regulatory Affairs Operations (RA Ops) submission group is organized to provide submission development support to project teams and the regulatory community; with product/projects assigned to RA Ops submission staff across divisions based on business need. This role serves as the primary point of RA Operations contact to assigned project teams. The focus of this position will be to support the compilation, development, publishing, submission and maintenance of regulatory filings in coordination with International Regulatory Affairs product associates as required by the business unit filing plans. The role works to tight, business-critical deadlines within a highly regulated environment. Additionally this role is responsible for the development and enhancement of selected processes relating to assigned programs submissions. S/he also ensures that compliance standards are met for receipt and delivery of information to and from external consultants and health authorities.
Key accountabilities include:
·Responsible for planning, building and delivery of electronic and paper regulatory submissions
Provide leadership to project teams around standards, compliance and publishing expertise.
·Actively participate in the definition, investigation and implementation of process efficiencies for paper and electronic submission publishing, including the evaluation of current processes.
·Proactive liaison to Regulatory organization to ensure optimal compliant, processes
·Ensure compliance with internal and global regulatory requirements
·Establish and build collaborative relationships with colleagues to support utilization of electronic technologies for submissions and tracking of documentation
·Develop and maintain SOPs for business processes
·Interfaces with RA Operations and Regulatory Managers to support product and non-product specific activities
·Undergraduate degree and/or 5-10 years relevant experience
·Experienced with regulatory submissions publishing and electronic review aids and understanding of application of technologies
·Experienced in use of DMS, MS Office tools, ISI Toolbox, and eCTD build tools
·Demonstrated ability to function autonomously in a matrixed environment.
·Articulate with strong analytical, decision-making, and interpersonal skills
·Demonstrated regulatory knowledge and awareness, technical competence, sound judgment, and a professional demeanor
·Demonstrated leadership and flexibility in dealing with change and diversity
·All candidates should have an understanding of the concepts around regulatory affairs and significant knowledge of submissions processes
State or Province