Regulatory Affairs Senior Associate,United States of AmericaR-0828320606 Seqirus Inc
With operations in 35+ nations and ~ 22,000 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!
The Senior Regulatory Affairs Associate role is a technical specialist role within the US, Region. The role contributes to the vision and goals for Global Regulatory Affairs and Seqirus, by providing specialist, regional advice and support. The role interfaces with other functions in Regulatory Affairs (e.g. Global Labelling, Regulatory CMC & Compliance, Regulatory Operations & Compliance,) and across the organization in Clinical, Commercial Operations and Business Development, etc to ensure collaborative connectivity with these key stakeholders, and a focused regulatory approach to supporting country and regional business objectives, or global R&D objectives. The Senior RA Associate will contribute to the implementation of global & regional objectives by leading and executing the global or regional strategy for one or more products under the direction of Senior RA Managers. The role will ensure high quality submissions and that all dossiers are up to date and compliant and that regulatory commitments are fulfilled. The role will develop collaborative and respectful relationships with staff at National Human Medicines Regulatory Agencies within the region (e.g. CBER/FDA, EMA, TGA). to build and maintain credibility for Seqirus, as related to their products/project.
Come join our growing organization! Seqirus is a global leader in influenza.
We have an exciting opportunity in Cambridge, MA to join our Regulatory Affairs department.
The Senior Regulatory Affairs Associate will contribute to the vision and goals for Global Regulatory Affairs and Seqirus, by providing specialist, regional advice and support.
Lead and assist in the formulation and implementation of global and regional regulatory strategies for Seqirus products
Lead the preparation and submission of high quality applications in Seqirus territories including IND, marketing authorization applications, variations, renewals and responses to questions
In collaboration with Global Strategic Labelling lead the development and maintenance of up to date product labelling for Seqirus products (PI, CMI, SmPC, PIL etc)
Provide regulatory expertise and guidance for the development and review of clinical protocols and reports
Provide regional expertise to global regulatory functions to ensure dossiers meet content requirements for applicable territories
Contribute specialist regional advice for global regulatory strategy development, especially for product development programs and complex technical changes
Establish and maintain strong and collaborative working relationships with assessors in Regions National Regulatory Agencies
Contribute to the global regulatory intelligence database as required and support the drafting of company position statements and responses to pending changes to regulatory legislation, Regulatory Agency Discussion Papers/White Papers
Actively contribute to the global Seqirus regulatory community through designated projects.
Degree in Life Sciences preferred
3-5 years regulatory affairs experience with specific regulatory knowledge and experience in US regulatory affairs
Experience in biologicals preferred
Effective delivery of objectives in a complex matrix environment
Effective verbal & written communication skills in a cross functional environment
Ability to present solutions to complex and strategic issues
CSL is introducing a new Career Framework, which will provide a common, global infrastructure for managing jobs and serve as a foundation for future career development and competitive rewards. Certain components of this job description, including Title and Level are subject to change relative to applicable local laws. Your Talent Acquisition Consultant will discuss the pending changes with you.