Global Regulatory Lead, Devices GRA GPS
With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
The Global Regulatory Lead (GRL) within GRA Global Product Strategy (GRA 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 Project Strategy Team (PST), Clinical Development Team (CDT), Safety Management Team (SMT) and Commercial Development Team to ensure the global regulatory strategy is incorporated and implemented within the 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 late life cycle products independent of development phase.
• 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.
• Role that this position reports to: Regulatory, TA Lead, GRA GPS or Sr/Global Regulatory Lead, GRA GPS
• Role/s that may report to this position: None
Main Responsibilities and Accountabilities:
1. Responsible for regulatory strategic input and decisions necessary to ensure development and execution of successful global regulatory strategies, submissions and approvals for assigned project(s) at all stages. Additionally, appropriate competitive decision making is applied when evaluating and proposing solutions to product development changes.
CSL Behring LLC will provide equal employment opportunity for all persons without discrimination on the basis of membership
in a legally protected class, including race, color, religion, national origin, gender, age, veteran status, or handicap/disability.
CSL Behring is committed to ensuring that diversity and inclusion are a part of our everyday business. CSLB18MAR13
2. Leads the Global Regulatory Affairs Strategy Team (GRAST) by:
• Being accountable for documentation of global regulatory strategy, e.g., Global Regulatory Strategy Outline (GRSO), and ensures it is current.
• Ensuring regional engagement in Global Regulatory Strategy development and execution of said strategy.
• Resolves and aligns internal GRA functional 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 product’s 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 Product Strategy Team (PST), Clinical Development Team (CDT) and Safety Management Team (SMT) for GRA. This includes provision of regulatory oversight of all aspects of chemistry, manufacturing and controls, non-clinical and clinical regulatory development and incorporation of appropriate PST & CDT deliverables into the global regulatory strategy.
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 TA Teams, GRA Strategy Management Review Team (SMRT), Therapeutic Project Review Committee, Therapeutic Area Leadership Team and other governance bodies, as appropriate.
Effectively demonstrate CSL Leadership Principles of Driving Performance, Building Productive Teams and Creating the Future.
• Holds people accountable for their performance and coaches individuals as needed to ensure they contribute at the right level
• Ensures efficiencies that contribute to our bottom line
Building Productive Teams
• Builds 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, builds virtual, cross-cultural, and/or cross-functional team
Creating the Future
• Understands CSL’s mission, vision, and strategy
• 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
Position Qualifications and Experience Requirements:
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, pharmaceutical, or medical device industry with at least 8 years in Regulatory (with 5+ years of that time in a developmental stage organization).
• Experience in the development of drug/device combination products or drug delivery systems.
• Prior medical device design control experience is preferred.
• 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/medical device 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.
• Strong ethics and integrity
• Self-motivated, pro-active and strategically focused. Creates innovative strategies and able to make decisions and think globally, while evaluating multiple program aspects including impact of decisions/strategy.
• Demonstrates professional confidence in his/her abilities and understanding of regulatory affairs.
• Demonstrated success in internal and external regulatory negotiations
• Strong leadership, verbal and written communication skills and a demonstrated ability to develop constructive and effective relationships with direct reports, colleagues and senior management.
• Proven ability to build and lead effective, well integrated, collaborative teams andempower team members.
• Strong team player with the communication and organizational skills to interact seamlessly both internally and externally on strategic, operational and scientific matters.
• Contributes to a first class results oriented team by setting clear expectations and holding people accountable.
• Creative problem solving/issue resolution skills with the willingness to take risks and act decisively
• Able to facilitate brainstorming in teams and open to creative thoughts of others
• Cross-cultural sensitivity demonstrating understanding and acceptance of different cultural parameters
The Global Diversity Principle/EEO Statement below must be included in all postings. Please be sure to include it when copying your position description into Taleo. Minimum requirements and flexible working hours will be considered as related to our EEO policy.
CSL Behring LLC will provide equal employment opportunity for all persons without discrimination on the basis of membership in a legally protected class, including race, color, religion, national origin, gender, age, veteran status, sexual orientation or handicap/disability.
CSL Behring is committed to ensuring that diversity and inclusion are a part of our everyday business.