Kelly Services Regulatory Associate in Indianapolis, Indiana
Title: Regulatory Associate
Duration: 18 months contract; possibly longer for the right candidate
Compensation: Up to $33.00 per hour
A BS or higher degree in a technical discipline such as chemistry, biology, pharmacy or equivalent demonstrated industry experience.
Knowledge of drug development process, regulatory/business strategies and plans
Demonstrated ability operate and manage operational requirements in a highly regulated environment
Demonstrated effective written, spoken and presentation communication
Demonstrated effective negotiation and influence skills
Demonstrated attention to detail
Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles
This role is accountable for the operational and technical registration management processes that support the expedited delivery of safe and effective products to patients. This is accomplished through a strong working knowledge of regulations, guidance’s and regulatory precedence and collegial and mutually productive relationships across all components, partner companies, and within relevant ministries of health. The scope of the work includes records from the start of clinical trials through withdrawal of the marketing application. It is expected that this position embrace corporate transformation initiatives and is capable of representing Global Regulatory Affairs.
Provide Regulatory & Drug Development Expertise
Lead the registration management process by providing expertise in electronic submission regulations and guidance and technical content for global submissions. This includes but us not limited to all submission types (Ad Promo, INDs, NDA, BLAs, NDSs,other eCTD MAAs, Renewals and Variations), and ensuring compliance with all applicable regulations and internal quality systems with a focus on delivery of the development portfolio across all modules of the CTD.
Partner with other geographies to understand and incorporate local agency regulations and requirements as needed. For example, lead the planning and execution for electronic submissions in those regions who have and are adopting the eCTD specification
Guide and influence development team and function regarding internal and Agency registration management processes and requirements
Own the registration management process at the molecule/project level to ensure all required electronic records are timely, complete, and accurate. Records include: tracking the submission status of pending applications and commitments as well as all communications with regulators (Incoming correspondence and records of contact).
Serve as the regulatory operational lead for registration planning and execution including but not limited to: planning sessions and status updates, team operation meetings and local department planning.
Own the routine compliance submissions and processes for molecules within areas of assigned responsibility (e.g. DSUR, NDA/BLA annual reports, PSUR/PADER, routine maintenance submissions).
Partner with the Regulatory Coordinator/Scientist to drive the execution of the product deletion, divestiture process, IND inactivation/withdrawal process, product withdrawal process
- May provide qualified candidates outside state. Qualified candidates are accepted from all US regions. Candidates must have highspeed internet connectivity for role and to support daily work.
Why Kelly ® ?
As a worker today, it’s up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what’s next is what we’re all about. We know what’s going on in the evolving world of work—just ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.
About Kelly ®
At Kelly , we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.
- Kelly Services Jobs