Global Regulatory Lead, GRA GPS
The Global Regulatory Lead – GRA Global Product Strategy (GRL-GPS) is responsible for providing strategic vision and innovative scientific and regulatory leadership in defining the global regulatory strategy for assigned projects.
•The GRL leads the Global Regulatory Affairs Strategy Team (GRAST) for assigned projects to ensure the development and delivery of science-based, solution-oriented, and globally aligned regulatory strategy.
•As the primary regulatory interface within CSL Behring for Global Regulatory Affairs (GRA) on specific development projects, the incumbent will have responsibility for ensuring collaboration with key internal stakeholders of the Core Project Team (CPT), Clinical Development Team (CDT), Safety Management Team (SMT) and Commercial Developmnet team to ensure the global regulatory strategy is incorporated and implemented within stakeholder deliverables.
•The GRL is accountable for the delivery of successful regulatory license applications globally, including new product development and product life cycle management related to new indications. The GRL may also provide clinical related input for Established Products independent of the phase of development.
•In partnership with Regional Leads, the GRL is also accountable to pro-actively support 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.
1) Responsible for regulatory strategic input and decision , necessary to ensure development and execution of successful global regulatory strategies, submissions and approvals for assigned project(s) of all stages. Additionally, appropriate competitive decision making is applied when evaluating and proposing solutions to product development changes.
2) Leads the Global Regulatory Affairs Strategy Team (GRAST) by:
•Owning the documentation of global regulatory strategy, e.g., Global Regulatory Strategy Outline (GRSO), and ensures that the documentation is current.
•Ensuring regional engagement in Global Regulatory Strategy development and execution of said strategy.
•Resolves and aligns internal GRA boundary inputs for GRAST members
•Meets regularly with individual GRAST members to understand the functional aspects of the project
•Utilizes appropriate departmental tools to consistently run and execute GRAST meetings
•Prioritization of global regulatory submissions based on team input
3) Responsible for development of core regulatory position and documentation necessary to support all interactions with global health authorities , as required to support products development. Represent the company, as required, at key regulatory agency meetings, regulatory advisory committee meetings or equivalents.
4) Serve as the Primary Regulatory Interface on the Core Project Team (CPT) and Clinical Development Team (CDT) for GRA on these teams. This includes provision of regulatory oversight of all aspects of chemistry, manufacturing and controls, non-clinical and clinical regulatory development and incorporation of appropriate CPT & CDT deliverables into the global regulatory strategy. Provide regulatory leadership into the development of the Target Product Profile and together with the Global Strategic Labeling Lead, develop and maintain the Developmental Company Core Data Sheet (dCCDS) or CCDS.
5) Provide strategic global regulatory perspective during the review and approval of internal and external documentation to support the development and commercialization of responsible product(s), including protocols, development safety update reports (DSUR)/ Product Safety Update Report (PSUR), annual health authority updates, clinical trial applications (CTA) / IND amendments, CTD documentation and post-approval change documents.
6) Present regulatory plans, risk assessments and strategies, pertaining to the assigned project(s), to senior review committees such as GRA Strategy Management Review Team (SMRT), Project Review Committee, Project Strategic Groups and PharmaPlan and others as appropriate.
7) Leverage effective relationships with regulatory experts and consultants to proactively optimize regulatory outcomes.
Requirements:
Qualifications:
Education : A bachelors degree in pharmacy, biology, chemistry, pharmacology clinical medicine or related life science is required. An advanced degree (MS/MBA, PhD or MD) is preferred.
Experience:
•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).
•Experience in leading and managing matrix teams (minimum 3-5 years), setting clear direction, holding people accountable and fostering a collaborative team environment.
•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)
•Experience working within the regulatory affairs (regional, clinical or CMC) in a global environment across two or more geographic areas (preferentially US and EU).
•Experience interfacing with regulatory agencies and proven skill at developing and implementing successful global regulatory strategies.
•Demonstrated experience in working with multiple stakeholders.
•Prior clinical regulatory foundation and/or management experience is preferred.
Worker Type:
Employee
Worker Sub Type:
Regular
