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 operates CSL 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!
Head Global Regulatory Affairs CMC (100%) (m/f/d)
The Head Global Regulatory Affairs Chemistry, Manufacturing & Controls (GRA CMC) leads global CMC regulatory professionals who support CSL Behring’s CMC business objectives. The Head of GRA CMC is a member of the Global Regulatory Affairs Leadership Team (GRALT) and contributes to the vision and goals for Global Regulatory Affairs (GRA) by:
Providing strategic vision, leadership, management and oversight in defining global CMC regulatory strategy for CSL Behring’s plasma and recombinant portfolio and being accountable for all CMC regulatory activities for the CSL Behring’ entire development and established product portfolio starting with product development and through clinical trial applications, new license applications and product lifecycle management.
Leading and overseeing the activities of the GRA CMC group at CSL Behring’s global sites, such as in the USA, Germany, Switzerland, Australia, and Japan.
For established products which are no longer in clinical development, is accountable to nominate Global Regulatory Leads (GRLs) to establish and maintain appropriate Global Regulatory Affairs Strategy Teams (GRASTs) and to ensure successful product lifecycle management.
Provides direction to senior management on emerging trends, regulations and changes within the regulatory CMC area, enabling proactive approach and planning to future business requirements in alignment with a culture committed to operational excellence.
Acts as the strategic regulatory interface to Senior Executives and peers of Recombinant Product Development, Plasma Product Development, Operations and Project Management and represents GRA’s strategic interests on key internal committees for CMC related topics.
Collaborating and aligning with GRA functional heads, as appropriate, including exchanging information on relevant topics.
Contributes as a member of GRA leadership meeting (GRALT), Strategy Mapping Regulatory Team meetings (SMRT), Process Council and Portfolio Committee within the GRA organization.
Contributes as a member of decision-making committee with other R&D, manufacturing and operations leaders.
Main Responsibilities and Accountabilities
Responsible to establish, develop and manage the function GRA CMC working in an efficient, productive and harmonized fashion to be the CMC regulatory experts for CSL Behring’ entire development and established product portfolio.
Ensures close cooperation and strategic alignment with GRA Therapeutic Area
Leads and GRA Regions as well as consistent approaches and further development of best practices.
Provides a global mindset and global CMC regulatory expertise to ensure that emerging trends/issues are addressed by utilizing creative problem solving skills, and proactively influencing the global regulatory strategy.
Accountable for all CMC regulatory development and product life cycle management strategy and activities for CSL Behring’s development and established products portfolio. This includes the provision of strategic regulatory advice for CMC changes to the relevant development, quality and manufacturing departments, as well as the change assessment and execution of changes in conjunction with GRA Regions.
Ensures the provision of high quality CMC information for CTAs, INDs and other regulatory submissions during product development as well as the preparation and revision of Module 2.3, Module 3 and related documents for new MAAs, BLAs and all life cycle submissions according to agreed schedules.
Ensures the timely provision of high quality responses to all CMC related Health Authority questions in conjunction with GRA Regions/GRA GPS, as required.
Accountable for nomination of Global Regulatory Leads for established products which are no longer in clinical development, establishment and maintenance of related product GRASTs and successful product lifecycle management.
Responsible to provide the strategic regulatory interface to Senior Executives and peers of Recombinant Product Development, Plasma Product Development, Operations and Project Management for CMC related matters.
Represents Global Regulatory Affairs on relevant key global committees.
Accountable and responsible for timely identification of regulatory risks associated with products and issues relating to emerging regulatory environment changes, escalates to Global Head GRA and as appropriate to Senior Management. Proposes risk mitigations as applicable.
Responsible to work closely with the Global Head GRA to establish and maintain an effective Global Regulatory Affairs organization. Is a member of the Global Regulatory Affairs Leadership Team and the Strategy Mapping Regulatory Team (SMRT).
Attends the GRA Process Council, Portfolio Committee with the aim to initiate and oversee global organizational and process development initiatives. Ensures appropriate contribution of GRA CMC to such initiatives.
Contributes to company Global Regulatory Strategy through participation on the GRALT, SMART, and Global Lifecycle Review Board (GLRB), as needed.
Accountable for CMC related content of all interactions with the FDA, EMA and other Regulatory Agencies for the company portfolio, working with and through the Regional Heads (ICH and International Regions).
Ensures expert participation in health authority meetings as required.
Empowers and advises the members of GRA CMC to ensure that the needs for CSL Behring’s CMC project portfolio are met. Additionally, provides strategic and tactical regulatory leadership and guidance for GRA CMC team members, as appropriate.
Responsible to interact with the functional heads of all GRA functions on a regular basis to assure the delivery of innovative and competitive solutions to accelerate program development, reduce risks and increase success rate.
Enables growth and professional development of the GRA CMC team members, including succession planning for critical roles with GRALT.
Responsible to develop/refine, implement and maintain global regulatory processes and operations for GRA CMC and to propose/implement/utilize electronic systems in line with GRA Operational Excellence.
An advanced degree in natural or related life sciences (MS, PhD or MD, DVM) and preferably a degree in Regulatory Affairs.
Minimum of 20 years’ experience in the biotech or pharmaceutical industry, with at least 15 years in CMC Regulatory Affairs.
Extensive experience (at least 5 years) at a senior level in Regulatory Affairs, Quality, or other relevant pharmaceutical industry roles.
Excellent track record in leadership roles (at least 5 years of experience) including managing direct reports, teams and large groups globally.
Sound knowledge of and practical working experience with international regulatory legislation and requirements, including more than one key region (EU, US, Japan).
Extensive experience in interfacing with regulatory agencies and demonstrated success in developing and implementing global regulatory strategies.
Experience working in a complex and matrix environment is required.
Demonstrated experience in working with multiple stakeholders.