Regulatory Operations Specialist Jobs

Summary:

The Regulatory Operations Specialist will report to the senior manager regulatory operations and provide support for the regulatory department to ensure efficient and compliant business processes associated with regulatory submissions.

Essential Functions and Job Responsibilities:

• Assist in the creation of submission planners for major submissions and per submission type
• Proactively work with teams to reduce “rework” to avoid time delays, while at the same time ensuring all necessary quality reviews and approvals are achieved, to produce applications to the highest quality standard.
• Maintain regulatory submission archives and logs
• Collaborate with Regulatory Strategists in coordinating contributions from cross-functional team members for routine and ad-hoc submissions such as periodic reports including annual reports, responses to Agency queries and information requests and other external communications requests.
• Prepare and route for review and signature, regulatory correspondence and draft submissions
• Formatting, publishing and assembly of regulatory submissions in support of INDs and NDAs
• Maintain working knowledge of regulations governing the content and formatting of submission documents, as required by the FDA, ICH, and other regulatory bodies
• Manage the regulatory activities log tracking annual and current submissions
• Assist in implementing use of templates and guidelines for documentation to be included in regulatory submissions; provide formatting assistance, advice and training to team members.
• Perform other related regulatory duties as required
• Contribute towards improving company processes and procedures while continuing to ensure compliance with applicable regulations and relevant standards.
• Assist with standard operating procedures (SOP) and working instruction (WI) creation, update, and maintenance
• Conduct proofreading and quality checks of regulatory documents and submissions

Minimum Qualifications:

• Knowledge of the regulatory archival, records and submissions systems with demonstrated ability to learn new systems and processes.
• Demonstrate ability to manage priorities, multi-task and follow projects through to completion
• Excellent writing skills (e.g., English usage), a keen attention to detail, and strong verbal and interpersonal communication skills
• Proficient in Microsoft Word, EndNote, Adobe Acrobat, Acrobat Plug-ins, Document Management Systems, Excel, StartingPoint templates
• High school diploma or equivalent, bachelor’s degree or certification a plus or equivalent education and at least 2-3 years of relevant experience
• Direct publishing experience a plus
• Ability to work autonomously under limited direction
• Experience in preparing INDs, CTAs, NDAs, BLAs and MAAs

The anticipated salary range for candidates who will work in Newark, California is $100,000 - $115,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, education, etc. CymaBay is a multi-state employer, and this salary range may not reflect positions that work in other states.

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