Regulatory Affairs Associate/Senior Associate

Principle Responsibilities

• Provide regulatory assistance with due diligence requests to support new business development activities.
• Support interaction with FDA and other regulatory agencies for assigned commercial products.
• Aid in compiling and authoring regulatory filings (IND, NDA, ANDA, etc.) and post marketing supplements for assigned products.
• Manage timelines associated with regulatory submissions such as post-marketing periodic reports.
• Manage archival of regulatory submissions, regulatory correspondence and associated logs and tracking mechanisms.
• Offer regulatory guidance on requirements for post-approval changes, as required, for assigned products.
• Review and provide regulatory assessments for change control documentation.
• Offer regulatory support to regulatory leadership meetings and presentations.
• Stay updated on current regulations and regulatory guidance, assessing their impact on assigned products and internal processes.
• Participate in various activities related to goal setting, tracking deliverables, and process improvements within the regulatory department.
• Perform other duties as assigned.

Qualifications and Education Requirements

• Minimum of Bachelor of Science or preferred advanced health care discipline degree (PharmD, PhD, Master of Science, etc.) or equivalent qualification.
• Minimum of 3 years in the pharmaceutical industry with at least 1 of those years in regulatory affairs.
• Excellent organizational, interpersonal, verbal, and written communication skills, strong grammar, and proofreading/editing skills, and MS Office skills are required.
• Ability to work independently with minimal supervision in a fast-paced deadline-driven environment.
• Keen attention to detail.
• Ability to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance, and great sense of urgency while ensuring that all cGMP and regulatory requirements are met.
• Ability to successfully communicate, negotiate, and influence regulatory strategy to key stakeholders.

Physical & Mental Requirements

• Must be able to sit for long periods of time.
• While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear.
• May occasionally climb stairs and/or ride elevators.
• The employee must occasionally lift and/or move up to 25 pounds.
• Employee must be able to manipulate keyboard, operate a telephone and hand-held devices.
• Other miscellaneous job duties as required.

Benefits We Offer

• Unlock Your Earning Potential: Competitive compensation package including an annual bonus based on company performance.
• Sales - In lieu of annual bonuses, incentive compensation program that allows you to earn more - even over plan.
• Fuel Your Success: Car reimbursement program and gas card for both business and personal use.
• Comprehensive Health Coverage: Excellent medical, dental, vision, and prescription coverage.
• Flexibility for Your Lifestyle: Hybrid work model allowing you to work two days from home and three days in the office.
• Invest in Your Future: Retirement Savings Plan (401K) with a match up to 5%.
• Time Off That Counts: Generous time off policy including up to 15 vacation days annually + rollover (up to 40 hours) as well as five sick/wellness days.
• Meaningful Time with Your Loved Ones: Extra week off between Christmas and New Year’s.
• Enjoy the Holidays: Recognition of 13 holidays throughout the year.
• Invest in Your Education: Tuition reimbursement for undergraduate and graduate level courses or certifications.
• Recognize and Be Recognized: Peer recognition platform for celebrating achievements and receiving recognition for outstanding work.