Global Regulatory Lead, Global Product Strategy (100%) (m/f/d)

Posted 22 days ago
Main Location
United States
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With operations in 35+ nations and ~ 20,000 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 operatesCSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company 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!

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. In Bern more than 1600 employees develop and deliver life-saving therapies to treat people with rare and serious medical conditions worldwide.

For our location in Bern (Switzerland), Marburg (Germany) or King of Prussia (USA), we are looking for a

Global Regulatory Lead, Global Product Strategy (100%) (m/f/d)

For the Therapeutic AreaTransplantation, 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 cross-functional collaboration with key internal stakeholders of the Product 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. 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 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.
Main Responsibilities and Accountabilities:


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.

Leads the Global Regulatory Affairs Strategy Team (GRAST) 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 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 and prioritization of global regulatory submissions based on team input.


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 Project Strategy Team (PST), Clinical Development Team (CDT) and Safety Management Team (SMT) for GRA. This includes provision of oversight of all developmental regulatory aspects comprising clinical, non-clinical and CMC related topics, and incorporation of appropriate team 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 clinical study protocols, safety update reports, clinical trial applications (CTA) / IND amendments, CTD documentation and post-approval change documents. This includes also specific regulatory procedural aspects, including Orphan Drug designations, pediatric plans and region-specific opportunities in support of optimal product development in close collaboration with agencies.


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), Therapeutic Product Review Committee, and additional governance committees, as appropriate.


Leverage effective relationships with regulatory experts and consultants to proactively optimize regulatory outcomes.

Qualifications & Experience:

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.

COMPETENCIES

  • 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.

CSL Behring is committed to provide equal employment opportunity for all.

Worker Type:

Employee

Worker Sub Type:

Regular

Mission
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Global Regulatory Lead, Global Product Strategy (100%) (m/f/d)
CSL