Covance Senior Director, Global Regulatory Affairs Strategy in Poland

Job Overview

The Senior Director of Global Regulatory Affairs Strategy (GRAS) willwork closely with sponsor companies in developing regulatory strategies that will support drug development initiatives. This responsibility will include leading client interactions with Regulatory Agencies globally. This position will also work as an internal consultant/advisoracross various Covance business units to facilitate dialogues with our clients to develop relevant regulatory strategy and tactical plans to meet their drug development needs globally.

Collaborate closely with internal Covance project teams in the design and development of regulatory strategies for client projects or to answer client inquiries.

  • Collaborate with the rest of the GRAS group in providing support and input for one another’s projects based on past therapeutic experience and global, regional and local regulatory expertise.

  • Maintain knowledge of the current regulatory environment by reviewing and communicating current policies/practices issued by EMA, FDA, Health Canada, and elsewhere.

  • Interact and collaborate with all Covance business unit personnel

  • Establish productive working relationship and collaborate closely with Regulatory Submissions staff.

  • Create and build confidence by representing the regulatory strategy function as an informed, capable, knowledgeable, responsible and accessible resource to Covance staff, management and clients, positioning Covance as a preferred source for regulatory strategy expertise.

  • Build successful working relationships with business and scientific leaders across Covance.

  • Provide regulatory affairs expertise and support to the business development group in presentations to Pharma/biotech customers when requested.

Education / Qualifications

Recommended: An advanced degree with a focus in the sciences is required, an MD or PhD is preferred.

Experience

  • Extensive experience of drug development in the Pharma, biotech or CRO industry with a significant amount of experience in regulatory affairs developing global regulatory strategies for early and late stage development programs.

  • Good expexperience working with Regulatory agencies at a Global level

  • CNS expertise

  • Lab expertise

  • Experience working with FDA is desireable

  • Strong leadership skills essential

Job Number 2018-19384

Job Category Other

Position Type Full-Time

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