King Of Prussia, PA
Industry: Medical Devices & Diagnostics•
11 - 15 years
Posted 267 days ago
The GRL is accountable to lead the Global Regulatory Affairs Strategy Team (GRAST) for assigned projects to ensure alignment of the regional and CMC regulatory strategies with the global regulatory strategy. As the primary regulatory interface, the incumbent will have responsibility for ensuring collaboration with key internal stakeholders of the Core Project Team (CPT) and the Clinical Development Team (CDT) to ensure successful planning and execution of the global regulatory strategy for assigned projects. The GRL is accountable for the delivery of successful regulatory license applications and product life cycle management related to new indications in close co-operation with the GRAST members (Regional Strategic Leads, Global Regulatory CMC lead, Global Strategic Labeling Lead, Global Regulatory Operations Lead). The GRL is also accountable to pro-actively support the regional strategic leads on the establishment and maintenance of high quality working relationships with the FDA, EMA, PMDA and other global regulatory agencies as appropriate for assigned therapeutic areas and products. Responsible for regulatory strategic decision making necessary to ensure planning and execution of successful global regulatory strategies, submissions and approvals for assigned project(s).
A postgraduate degree in pharmacy, biology, chemistry, pharmacology clinical medicine or related life science is required/preferred (MS, PhD or MD). Relevant regulatory affairsexperience may be considered in lieu of postgraduate degree.
o Minimum of 10 years’ experience in the biotech or pharmaceutical industry, with at least 8 years in Regulatory (with 5+ years of that time in a developmental stage organization).
o Experience in leading and managing matrix teams (minimum 3-5 years), setting clear direction, holding people accountable and fostering a collaborative team environment.
o Candidates must have thorough knowledge and understanding of pharmaceutical/biological product development and regulatory requirements for product development and approval in more than one key region (ie. EU, US, Japan)
o Experience working within the regulatory affairs (regional, clinical or CMC) in a global environment across two or more geographic areas (preferentially US and EU).
o Experience interfacing with regulatory agencies and proven skill at developing and implementing successful global regulatory strategies.
o Demonstrated experience in working with multiple stakeholders.
o Prior clinical regulatory foundation and/or management experience is preferred.