Regulatory Affairs Specialist I

The Regulatory Affairs Specialist I will support the day-to-day regulatory activities and operations of assigned projects. These include assisting with the preparation and compilation of
submissions for regulatory agencies, supporting the management of regulatory
operational processes and timelines, and maintaining regulatory tracking tools, archives, and infrastructure, as assigned.

Primary Duties and Responsibilities:
• Support the review, finalization, and internal sign-off of regulatory notifications.
• Assist with commercial product notification activities as assigned.
• Support the notification process by gathering data, preparing draft documents,
routing materials for review, assisting with final submissions, and maintaining submission records.
• Maintain tracking logs for regulatory notifications, submissions, and approvals.
• Support preparation, submission, and tracking of documents for license and
registration renewals (e.g., tissue bank licenses, FDA food facility registration).
• Assist in preparing background materials for communications with regulatory authorities.
• Manage regulatory document archives and support document control processes.
• Upload regulatory documentation into electronic systems and ensure availability
to relevant departments.
• Assist in drafting, revising, and maintaining Regulatory Affairs SOPs.
• Create and maintain templates for regulatory and health agency submissions

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to View email address on click.appcast.io learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:


Required Skills & Experience
- Bachelor's degree in science field and 0-2 years of relevant experience in a regulated environment.
• Familiarity with US, EU, and/or RestofWorld (ROW) notification, submission,
and registration types and requirements.
o Knowledge of FDA regulations, Food and Infant Formula guidance, process/product development processes, and industry standard practices is highly desired.
• Understanding of GxPs (GCP, GLP, GMP
- Proficient in MS Office (Word, Excel, PowerPoint); experience using electronic document management systems and document review tools desirable


Nice to Have Skills & Experience
- Basic knowledge of promotion, advertising, and labeling requirements (may be
developed through tenure in this position).
• Excellent interpersonal skills to assist to build and maintain cross-functional partnerships and ensure the lines of communication are professional and collaborative.
• Ability to prioritize in a fast-paced environment and keep track of multiple projects
with different requirements and deadlines.
• Ability to research and locate information on regulatory requirements, products,
and technical topics.
• Excellent verbal and written communication skills. Ability to write and edit technical documents.
• Detail-oriented and strong documentation, organization skill.
• Strong presentation skills to individuals and groups.
• Experience with regulatory notification documentation and processes is highly
preferred.


Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.