Associate Director, IVD Regulatory Consulting

Position Summary:

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]).

Essential functions of the job include but are not limited to:

Consulting Services

• Direct the preparation of submissions and other documentation as required for global clearance/approval of in vitro diagnostics, including Precision’s own CDx products, including the preparation of regulatory submissions, meeting packages, reports and negotiations with regulatory officials as required
• Serve as a regulatory lead on Precision CDx program development project teams, contributing toward DHF documentation and participating in meetings with pharma partners
• Represent Precision or client in correspondence and meetings with regulatory agencies
• Design strategic approaches to regulatory approvals, clearances, and post-market requirements to reflect the optimal business solutions for clients in the US.
• Support the Precision QA team in recall and MDR reporting to regulatory agencies for Precision CDx products
• Review and direct the development of analytical and clinical protocols, technical reports, and other company documents for use in regulatory submissions and in response to queries from regulatory agencies globally.
• Identify and collaborate with external thought-leaders and technical experts required to support research and development, regulatory authorization, and marketing
• Responsible for reviewing and providing information for program essential tools such as project plans, communication plans, etc.
• Review and edit regulatory communication, submission, timeline, and approval requirement documents for assigned programs and other initiatives
• Apply quality systems expertise to guide clients towards successful readiness to market products in a regulated environment
• Stay abreast of latest regulatory developments and communicate to the project teams for impact and possible implementation within Precision’s CDx programs.
• Perform regulatory impact assessment for any changes to Clinical and Commercial products for regulatory reporting for Precision’s CDx products.

Business Development

• Generate new business through your own network
• Work in conjunction with the management team within the organization to design and develop customized, program recommendations and preliminary strategies for inclusion in client proposals
• Lead workshops and conference curriculums in the areas of translational and regulatory science for in vitro diagnostics
• Work in partnership with the business development team to support the evaluation of requests for proposals and consider regulatory strategies that can be leveraged and regulatory approval timelines
• Advise on work orders, change orders, master service agreements and other contract related documents
• Collaborate with the business development account management team to convert new business prospects into awarded and contracted business by participating in general capabilities presentations
• Proactively identify client needs and develop solutions by gaining an understanding of the client’s product, the brand objectives and other relevant industry trends
• Stay abreast of the latest regulatory and scientific developments in the marketplace that will impact the line of business by identifying market trends, paradigm shifts, etc.
• Support the development and refinement of the “go to market” strategy

Administrative

• Review and edit standardized start-up procedures for new programs and consulting engagements by creating regulatory check-lists, customized hot sheet, etc.
• Ensure quality and integrity of all client work products and engagements, consistent with corporate standards.

• Manage, motivate and develop staff to ensure a scalable model within the Regulatory practice as a whole
• Support and contribute to Precision for Medicine culture

Qualifications:

Minimum Required:

• Bachelor’s degree in Life Sciences or equivalent work experience
• Minimum 2+ years of applicable consulting experience with a focus in regulatory affairs
• Minimum of 5+ years of experience working in a medical device, pharmaceutical management, clinical trial and/or pharmaceutical services consulting environment, or an in vitro diagnostics environment, preferably with CDx

Other Required:

• Strong written and verbal communication skills
• Strong leadership, team building and interpersonal skills
• Strong business and financial acumen
• Strong scientific and analytical skills
• Ability to think outside of the box and solve difficult problems with effective solutions
• Direct experience working with small and large companies to design global regulatory and commercialization strategies
• Experience managing staff members and project teams
• Ability to read, write, speak fluently, and comprehend the English language

Preferred:

• Master’s degree
• Class III IVD, preferably CDx experience
• FDA PMA and IVDR experience

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