Global Regulatory Lead, GRA Global Product StrategyUnited States of America, Germany, SwitzerlandR-0562622012 CSL Behring L.L.C.
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 Core Project Team (CPT), 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.
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.
Serve as the Primary Regulatory Interface on the Core Project Team (CPT), 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 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.
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.
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 Leadership Groups and PharmaPlan, as appropriate.
Leverage effective relationships with regulatory experts and consultants to proactively optimize regulatory outcomes.
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 3-5 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.
- 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 and empower 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