Senior Manager, Regulatory Affairs CMC

CSL Seqirus is a global leader in influenza prevention and the worlds second-largest influenza vaccine provider operating as a specialized division of CSL Limited. Headquartered in Melbourne Australia with major manufacturing hubs in Holly Springs NC and Liverpool UK the company operates the worlds largest cell-based vaccine facility and serves as a primary partner to governments for global pandemic preparedness.Joining Seqirus now means being part of an agile team committed to developing vaccines that make a meaningful difference worldwide.

Could you be our next Senior Manager Regulatory Affairs CMC The job is in our Holly Springs NC or Liverpool UK Office. This is a hybrid position and is onsite three days a week. You will report to the Team Lead Global Regulatory Affairs CMC.

You will be responsible for:

• Partnering closely with CSLs R&D Manufacturing Quality Regulatory Affairs stakeholders to address regulatory strategy challenges and deliver innovative timely regulatory solutions that meet evolving CMC regulatory and compliance requirements for the assigned product portfolio.

• Defining global regulatory strategies objectives and policies that advance and support the development registration and lifecycle management of CSLs biological & non-biol. products.

• Represent CSL in official regulatory CMC capacities acting as an authorized official or responsible person in interactions with regulatory agencies.

Responsibilities:

• Lead the global regulatory CMC strategy across the assigned development and commercial biological & non-biol. product portfolio collaborating closely with cross-functional leaders in Global Regulatory Affairs CMC Global Regulatory Affairs R&D Quality Global Operations and other business functions.

• Manage the development and submission of high-quality compliant CMC regulatory submissions and submission components including new marketing applications clinical trial applications variations/supplements periodic compliance reports and renewals. Ensure timely execution aligned with regulatory expectations and business goals.

• Ensure accurate and timely change control assessments of change control notifications in CSLs quality management system for biological & non-biol. product-related change controls. This includes the country-specific reporting category and detailed submission documentation requirements.

• Leverage external insights to refine strategies and implement innovative regulatory approaches that enhance CSLs competitive positioning for its biological & non-biol. product portfolio.

• Represent CSL in official regulatory CMC capacities acting as an authorized official or responsible person in interactions with regulatory agencies. Maintain strong positive relationships with regulators and ensure timely responses to inquiries and requests. Facilitate timely decision-making and guidance from health authorities through effective communication and relationship management.

• Develop strategic and tactical plansfor Global Regulatory Affairs CMC advising Global Regulatory Affairs CMC leadership and CSL stakeholders on regulatory requirements and their implications for project timelines compliance and business strategy. Contribute to the evaluation of new business opportunities in collaboration with development teams.

• Provide regulatory consultation to internal CSL functions including Global Operation functions R&D and IT to support the design and implementation of business processes that ensure regulatory compliance and operational excellence.

• Provides tactical and strategic regulatory input and guidance including active participation in problem solving analysis by assessing and proposing alternative solutions to issues and prepare contingency plans while still meeting regulations.

Qualifications-

• A Bachelors degree in biological or chemical sciences or a related field is required; an advanced degree (e.g. MS PhD) is strongly preferred.

• Over 5 years of progressive experience in regulatory roles within the biologics or plasma industry demonstrating increasing levels of responsibility.

• Strong technical foundation with in-depth knowledge of global regulations and international standards governing drug product development manufacture registrations and life-cycle management.

• Proven expertise in authoring reviewing and managing regulatory submissions ensuring accuracy compliance and timely delivery.

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About CSL Seqirus

CSL Seqirus is part ofCSL. As one of the largest influenza vaccine providers in the world CSL Seqirusis a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S. the U.K. and Australia CSL Seqirus utilizes egg cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

To learn more about CSL CSL Behring CSL Seqirus and CSL Vifor visit and CSL Plasma at Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being CSL.

You Belong at CSL

At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process please visit our On the Front Line video to learn more about CSL Seqirus