Associate Director, Regulatory Consultant - Remote

Overview

The Associate Director, Regulatory Consultant will be responsible for applying high-level expertise and in-depth knowledge of the regulatory affairs, quality systems and marketing authorization process for small and large pharma and diagnostics companies to develop business solutions for clients and colleagues within Precision for Medicine (Precision). This position will also serve as regulatory liaison with regulatory agencies and pharma partners for Precision diagnostic products (e.g., companion diagnostics [CDx]).

In Short

• Direct the preparation of submissions and documentation for global clearance/approval of in vitro diagnostics.
• Serve as a regulatory lead on Precision CDx program development project teams.
• Represent Precision or client in correspondence and meetings with regulatory agencies.
• Design strategic approaches to regulatory approvals and post-market requirements.
• Support the Precision QA team in recall and MDR reporting.
• Review and direct the development of analytical and clinical protocols.
• Identify and collaborate with external thought-leaders and technical experts.
• Manage, motivate and develop staff within the Regulatory practice.
• Stay abreast of latest regulatory developments.
• Generate new business through your own network.

Requirements

• Bachelor’s degree in Life Sciences or equivalent work experience.
• Minimum 2+ years of applicable consulting experience in regulatory affairs.
• Minimum of 5+ years of experience in a medical device or pharmaceutical environment.
• Strong written and verbal communication skills.
• Strong leadership and interpersonal skills.
• Strong business and financial acumen.
• Ability to think outside of the box and solve difficult problems.
• Direct experience with regulatory and commercialization strategies.
• Experience managing staff members and project teams.
• Fluency in English.

Benefits

• Discretionary annual bonus.
• Health insurance.
• Retirement savings benefits.
• Life insurance and disability benefits.
• Parental leave.
• Paid time off for sick leave and vacation.