Title: Regulatory Associate
Location: Indianapolis, IN
Schedule: 8am to 5pm Mon – Fri.
Start date: ASAP
- Handles adverse event reports from scientific literature by collecting, reviewing, and entering global adverse events reports
- Routes applicable literature on adverse event cases to the appropriate clinical safety physician for review.
- Provides support to global personnel regarding Global Product Safety policies, processes and procedures by updating SOPs, training tools/programs as necessary.
- Ensures regulatory compliance for expedited submission of case reports to regulatory authorities.
- Collaborates with internal and external customers to prepare quality periodic/annual safety summary reports
- Partners with Global Product Safety physicians to maintain and communicate product safety profile analyses to appropriate persons and groups (e. g. , regulatory agencies).
- Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including a comprehensive knowledge of ICH CTD and evolving global agency standards, of CMC RA submission processes, electronic submission regulations and guidance regarding structure requirements to CMC development teams regarding global CTAs and registration dossiers. Responsible for preparing CMC CTD content consistent with approved manufacturing changes, technical reports and procedural requirements.
- Partner with the CMC RA Scientist to plan and prepare submission content to support clinical studies and manufacturing process changes for development and marketed products.
- Partner with the CMC RA Scientist to drive the execution of submission planning for global registration and maintenance submissions.
- Responsible for triage of affiliate inquires and requests and when necessary consults with CMC RA Scientist for guidance in effort to prepare responses to questions.
- Implement and in some cases interpret global regulations and guidances and look to regulatory precedence into submission processes and publishing standards to ensure final document content and structure are aligned with local regulatory requirements. Partner with affiliate regulatory staff, as necessary, to gain alignment on establishing new submission standards to meet local agency requirements.
- Create an environment within the Global Regulatory Area and across CMC development teams that encourages open discussions on issues to achieve a robust outcome on project decisions. Constructively challenge teams to reach the best solutions to issues.
- Leverage internal forums to continue to develop and share regulatory and drug development expertise to meet critical product registration timelines and electronic submission structure and content requirements.
- Communicate effectively to guide and influence within work group/function and with development team regarding life-cycle management processes
- Demonstrate strong problem-solving skills and ability to address and effectively communicate regulatory issues across multiple functions and geographies
- Bachelor’s Degree in a scientific or health sciences discipline (e.g. pharmacy, chemistry or related scientific discipline)
- Knowledge of pharmaceutical drug development or industry-related experience preferred.
- Qualified candidates must be legally authorized to be employed in the United States.
- Drug development process or Industry-related experience
- Knowledge of Agency submission procedures and practices.
- Knowledge / awareness of emerging submission electronic standards.
- Ability to operate and manage operational requirements in a regulated environment
- Written, spoken and presentation skills
- Negotiation and influence skills
- Attention to detail and ability to effectively prioritize
- Proven effective teamwork skills; able to adapt to diverse interpersonal styles
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.