Posted in Compliance 7 days ago.
Type: Full Time
TOGETHER, WE CAN BEAT CANCER.
AT VARIAN, WE BRING TOGETHER THE WORLDS BEST TALENT TO REALIZE OUR VISION OF A WORLD WITHOUT FEAR OF CANCER. TOGETHER, WE WORK PASSIONATELY TO DEVELOP AND DELIVER EASY-TO-USE, EFFICIENT ONCOLOGY SOLUTIONS. IF YOU WANT TO BE PART OF THIS IMPORTANT MISSION, WE WANT TO HEAR FROM YOU.
The Senior Regulatory Affairs Specialist is responsible for developing strategies for worldwide governmental approval to introduce new products to market, maintain existing products, provide advice on regulatory requirements, prepares worldwide submissions and negotiates their approval with the agencies. In addition, this position also assists with the training of other regulatory affairs associates. Duties to include:
Perform the coordination and preparation of document packages for regulatory submissions from all areas of company as well as internal audits and inspections.
Compiles all materials required in submissions, license renewal and annual registrations.
Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes.
May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications.
Experience Level with Business Tools:
Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, and PowerPoint. Experience with HCM (e.g., Workday) or equivalent ERP product and productivity software desired.
Typical Education and Experience: Bachelors degree (or equivalent experience) and 8 years of related experience or Masters Degree with 6 years of related experience.
FIGHTING CANCER CALLS FOR BIG IDEAS.
We envision a world without fear of cancer. Achieving this vision takes dedication and commitment from all of us, every single day. That's why we celebrate and value the distinctly beautiful and intersectional identities of each of our employees. We are a mirror of our patient-base, which allows us to innovate. Big ideas come from everywhere, and the best ideas are fostered by our unique individual experiences. At Varian, we encourage you to bring your whole self to work and believe your bold and authentic perspective will help to power more victories over cancer.
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability.