Director, CDx Strategy & IVD Regulatory Consulting

Position Summary:

The Director, Regulatory Consultant will be responsible for applying extensive expertise and in-depth knowledge of the regulatory affairs, quality systems and marketing authorization process for small and large pharma and life science companies to develop actionable business solutions.

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 the preparation of reports and negotiations with regulatory officials as required

Design strategic approaches to regulatory approvals, clearances, and post-market requirements to reflect the optimal business solutions for clients

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.

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

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

Assist the business development team with client bid defense meetings by clearly and succinctly communicating the key regulatory considerations of the program to the project team and assisting with the development of the presentation materials for these meetings

Be the regulatory compliance subject matter expert who can speak to the strategic positioning and considerations of the program within the healthcare marketplace and who can discuss the established precedents from other similar programs

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 5 years of applicable consulting experience with a focus in regulatory affairs

Other Required:

Minimum of 7 years of experience working in a medical device, pharmaceutical management, clinical trial and/or pharmaceutical services consulting environment

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

Preferred:

Master’s degree

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational ne…