Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of the company, internal audits, and inspections.
Leads or compiles all materials required in submissions, license renewals, and annual registrations.
Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
Monitors and improves tracking/control systems.
Keeps abreast of regulatory procedures and changes.
May direct interaction with regulatory agencies on defined matters.
Recommends strategies for the earliest possible approvals of clinical trial applications.

Requires a Baccalaureate degree
Minimum of 7 years of relevant experience, or an advanced degree with a minimum of 5 years of relevant experience
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

Senior Regulatory Affairs Program Manager

Key skills