Regulatory Coordinator

We are seeking a detail-oriented and highly organized Regulatory Coordinator to join our team in a fast-paced pharmaceutical environment. This role is critical in supporting the operational running of the Regulatory, Quality and Safety teams and functions and supporting regulatory compliance and quality in these highly regulated environments. The ideal candidate have strong administrative and time management skills, high-level of computer and digital proficiency, and a commitment to maintaining records and data integrity and confidentiality. In line with our performance drivers we expect our team members to role-model accountability, collaboration, and entrepreneurship.
Provide business and operational support for Regulatory, Quality and Safety functions.
o Process vendor contracts and agreements and purchase orders and set up in company systems, manage invoices and payment requests.
o Track all function expenses/payments against annual budget(s)
o Support onboarding/offboarding and coordination for new employees and agency workers with starting within the functions
o Coordinate & arrange any off-site functional meetings including face to face FDA Meetings
o Regulatory submission coordination and tracking in eSub “Submission Booking System” of all upcoming Annual Reports for: NDAs & INDs / PADERS (Periodic Adverse Drug Experience Reports) / Safety Quarterly & Device
o Manage regulatory archive and all incoming and outgoing communications to/from the FDA
o Support Quality function with log book receipt and archives
o Receipt of complaint samples, storage and coordination with QA.

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 HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

- Committed to working on-site in office minimum 4 days weekly
- 2+ years experience in administrative or department operations support at a mid-large size corporate, which must include
o Skilled use in using Microsoft based software (Outlook, teams, SharePoints, excel, word) and Adobe
o User experience with contract legal management systems (e.g. Icertis, Adobe Sign)
o User experience with finance/procurement management and payment systems (e.g. COUPA)

• Preferably experience and interest in working in regulated pharmaceutical or biotech environment
• Familiarity with GxP requirements
• Experience supporting FDA regulatory submissions or documentation and/or quality systems
• Veeva document management experience

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.