Director of Regulatory & Regulatory Strategy (440773)

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POST DATE 9/13/2016
END DATE 10/12/2016

Advanced Clinical Lexington, MA

Lexington, MA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Mid-Career (2 - 15 years)
Bachelors Degree


Job Description:

OVERVIEW:Determines and develops the global regulatory strategy and objectives for interactions with FDA and other governing bodies.Accountable for preparation and filing of briefing books, including coordination and planning for pre-Submission meetings with FDA.Develop high quality and globally aligned regulatory strategies to achieve optimal development objectives and life cycle management plans Develops and implements required plans for response to HA requests and coordination of any applicable follow-on activity Serve as the key OPM program specific liaison with FDA and lead interactions with HAs Lead program efforts relative to premarket submission, diagnostic partnering, FDA inter-face, regulatory policy and practice. Responsible for the Dx regulatory strategy that is aligned with the Drug/Diagnostic Co-development.Responsible for leading the coordination and implementation of regulatory readiness; this is includes Diagnostics Development, Biostatistics, Clinical Affairs, Quality Assurance and external diagnostic partners.Develop and ensure diagnostic & regulatory input during clinical development to Technical and Clinical Development teams for companion diagnostic testsSupport the vision for regulatory affairs for molecular diagnostics and the action roadmap for activities with the regulatory bodies to ensure Novartis interests are reflected.Key lead to providing regulatory input for BD&L and M&A activities with respect to the regulatory risks and benefits of potential dealsLead the development of training for key stakeholders internal and external Works directly with the ROW OPM regulatory leads to support their OPM program interactions with the local ROW HAResponsible for leading and implementing an integrated global strategy into regional submissions worldwide for companion diagnosticsResponsible for submission of required IDEs for therapeutic trialsApplies the least burdensome approach to preparation and submission of CDx regulatory dossiers Responsible for development of global dossier summary documents for CDx. Responsible for facilitating timely submission and approval of PMAs. Education:Science/life sciences based BS or MS with requisite experience and demonstrated capability for medical devices and diagnostics. Advanced degree (Ph.D.) in molecular biology considered a plus. Languages: Fluency in English as a business language. Additional language is an asset Experience/Professional requirement: Strong knowledge and experience in leading regulatory submission and approval in the U.S. and other major regions7-10 years work related professional experience in in vitro diagnostic, medical devices and life sciences. 4-6 years experience in diagnostic regulatory affairs.Experience in molecular diagnostics and diagnostic development considered a plus. Knowledge of drug development and regulatory affairs requirements is an assetFamiliar with regulatory issues and challenges associated with Drug/Diagnostic co-development and companion diagnostics. Developed understanding of molecular technologies and the impact on outcomes and diagnostic results Strong leadership capabilities working across cultures, expertise and backgrounds. Excellent negotiation skills with regulatory staff on various levels of hierarchy. Strong interpersonal and communication skills for bridging scientific and business participants, for negotiating timelines and for effective collaboration with HA.Strong verbal and written communication skills.Ability to influence cross-functional team members.

Company Description:

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