Director, Senior Global Regulatory Lead, GRA GPSアメリカ合衆国R-0550642012 CSL Behring L.L.C.
The Director, Senior Global Regulatory Lead (Sr. GRL) is a member of a GRA GPS Therapeutic Area and contributes to the vision and goals for Global Regulatory Affairs (GRA) by:
- Providing innovative scientific and regulatory vision, and leadership in defining aligned global regulatory strategies for assigned products within CSL Behring’s developmental portfolio and accountable for clinical and safety content globally of CSL Behring regulatory documentation for these projects.
- As the primary regulatory interface within CSL Behring for Global Regulatory Affairs (GRA) on specific 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 Development to ensure the global regulatory strategy is an integral component of stakeholder deliverables.
- For early development projects, the Sr. GRL is a company resource for global regulatory perspective and drives the GRA perspective within the company.
- The Sr. GRL leads the Global Regulatory Affairs Strategy Team (GRAST) for assigned projects to ensure the development and delivery of innovative, science-based, solution-oriented, and globally aligned regulatory strategy.
- The Sr. GRL is accountable for the delivery of successful regulatory license applications globally, including new product development and product life cycle management
In partnership with GRA Regional Leads, supporting the establishment and maintenance of high quality working relationships with the FDA, EMA, PMDA and other global regulatory agencies.
Responsibilities and Accountabilities:
-Responsible for leading regulatory strategic decision making that enables a project to meet its business and regulatory deliverables. This includes developing and advocating for scientifically sound core regulatory strategies (clinical, non-clinical, & CMC) that result in successful regulatory submissions and approvals for assigned project(s) at all stages of development. Additionally, appropriate competitive decision making is applied when evaluating and proposing solutions to product development changes, specifically in the early development space.
-Leads the Global Regulatory Affairs Strategy Team (GRAST) by:
- Leading the development of the global regulatory strategy, e.g., Global Regulatory Strategy Outline (GRSO). Proactively adapts the strategy to ensure new information is incorporated and includes start-of-the-art regulatory intelligence.
- Ensuring regional engagement in global regulatory strategy development and execution.
- Resolving internal GRA boundary inputs for GRAST members
- Utilizing appropriate departmental tools to consistently run and execute GRAST meetings
- Prioritizing global regulatory submissions based on team input
-Represents the company as the global regulatory product expert at key regulatory agency meetings, regulatory advisory committee meetings, scientific conferences or equivalents.
-Serves as the Primary Regulatory Interface on the Core Project Team (CPT), Clinical Development Team (CDT) and Safety Management Team (SMT) for GRA, advocates and drives the ‘one GRA’ perspective with team stakeholers. Accountable for scientific clinical / safety related regulatory submission content globally for assigned products.
-Reviews and approves 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.
-Leads the development of regulatory plans, risk assessments and strategies, pertaining to the assigned project(s) and presents to senior review committees such as GRA Strategy Management Review Team (SMRT), Project Review Committee (PRC), Project Leadership Groups (PLG) and PharmaPlan and others as appropriate.
Actively promotes appropriate leadership behaviors in one’s work, including:
- Sets clear expectations/objectives aligned with CSL Company Objectives
- Holds people accountable for their performance and mentors individuals as needed
- Ensures operational efficiencies that contribute to our bottom line
Building Productive Teams
- Fosters a productive, engaging team culture and climate based on trust, respect, and mutual support
- Builds networks with other CSL teams to support business objectives (“One CSL”)
- When required, uses appropriate approaches to build virtual, cross-cultural, and/or cross-functional teams
Creating the Future
- Serves as a role model for CSL’s Values
- Lives CSL’s mission, vision, and strategy and develops action plans to drive strategy execution
- Is dedicated to fulfilling the needs of internal and external customers and stakeholders
- Challenges the status quo; fosters innovation and continuous improvement
- Applies business acumen skills to help grow the business
Qualifications and Experience:
A bachelor’s degree in pharmacy, biology, chemistry, pharmacology, clinical medicine or related life science is required. An advanced degree (MS/MBA, PhD or MD) is preferred.
- 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 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 (i.e., 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), with proven skill implementing successful global regulatory strategies.
- Experience interfacing with regulatory agencies, including leading and preparing the sponsor’s team for an interaction.
- Demonstrated experience in working with multiple stakeholders, across geographies.
- Experience working in a complex and matrix environment is required
- Prior clinical regulatory foundation is preferred.