Life Sciences & Healthcare Regulatory Associate with Pricing Experience - Mid-Level

Life Sciences & Healthcare Regulatory Associate with Pricing Experience - Mid-Level ARC ENT Boston, MA Job Details Full-time $200,000 - $350,000 a year 12 hours ago Qualifications FDA submissions Law U.S. District Court experience ISO standards Healthcare fraud investigations Collaborating with government agencies Research Mid-level Legal firm experience 3 years Regulatory legal research Legal research Law office Regulatory submissions Regulatory audits Bar Healthcare compliance Communication skills Full Job Description This prestigious American multinational law firm is known for its expertise in corporate law, litigation, and regulatory matters. Established in the mid-20th century, it has grown into one of the largest firms globally, both in revenue and number of attorneys. With offices across the U.S., Europe, and Asia, the firm specializes in areas such as antitrust, financial services, compliance, corporate governance, and dispute resolution. It has a strong reputation for handling high-profile cases, including landmark Supreme Court decisions. Additionally, it is recognized for its commitment to pro bono work, having contributed thousands of hours to social justice causes.

Requirements:

Candidate Must have the following: Minimum 3 years of considerable experience working on drug, fraud and abuse matters within a large law firm setting (experience will be current or very recent) ; Direct experience working on drug pricing matters is required ; Significant involvement with both the 340B Program and the Medicaid Drug Rebate Program ; Exposure to precedent-setting litigation and internal investigations, and commenting on key rulemakings. Stellar academic credentials (Law Review and/or Moot Court accolades desired); Strong research, verbal & written communication skills, and analytic skills required ; Texas Bar. Day to

Day Responsibilities:

Responsibilities include, but are not limited to: Representing a diverse clientele including life sciences entities, global enterprises, emerging developers and manufacturers, laboratories and research institutions. Preparing/submitting regulatory filings (INDs, NDAs), auditing, interpreting new regulations, and communicating with agencies like the FDA. Researching and implementing new regulations to ensure organizational compliance. Maintaining, auditing, and enforcing compliance with current laws, standards, and guidelines (e.g., GCP, ISO). Aiding clients in the areas of biologics, medical devices, drugs, diagnostics, foods/dietary supplements, and cosmetics. Assisting clients in all areas of life sciences product and healthcare provider/supplier regulation. Acting as liaison between the organization and local, federal, or international regulatory agencies.

Pay:

$200,000.00 - $350,000.00 per year

Work Location:

In person