CSL Plasma
Senior Manager RA - CMC & Compliance
At a glance
Location: US-NC-Holly Springs Map
Posted: 11/08/2020
Closing: 12/07/2020
Degree: Graduate Degree
Type: Full-Time
Experience: Not Specified
CSL Plasma
Job description
About CSL

With operations in 35+ nations and ~27,000 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 one of the largest influenza vaccine companies 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!


Job Description

The Senior RA Manager, CMC & Compliance is a strategic leadership role within the CMC & Compliance regulatory team. The role contributes to the vision and goals for Global Regulatory Affairs and Seqirus, by providing specialist strategic advice and support to Project/Product teams, Quality Operations and

Manufacturing Operations.

The role interfaces with other functions in Regulatory Affairs and

R&D (e.g. Regional Regulatory Affairs, Regulatory Operations & Compliance,

Technical Development and Project & Portfolio Management) and across

the organization in Quality Operations and Manufacturing Operations, 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 Manager, CMC & Compliance will influence, lead and execute the CMC regulatory strategy for all Seqirus products. The role will ensure high

quality submissions and that all dossiers are up to date and compliant and that regulatory commitments are fulfilled.

The Senior RA Manager, CMC & Compliance may have direct reports and will be responsible for the planning and oversight of the work to be conducted by their reports, and for the “on the job” training and coaching of their reports.

The role will develop collaborative and respectful relationships with staff at

National Human Medicines Regulatory Agencies (e.g. CBER/FDA, EMA,

TGA). The Senior RA Manager, CMC & Compliance will represent the company at external regulatory agency meetings as relevant to their product portfolio.

Responsibilities and Tasks Include: -

Formulate, lead and drive the development and implementation of the global CMC regulatory strategy for Seqirus development programs/products, licenced through all development phases to registration/licensure and approval/post approval lifecycle stages.

Lead/Oversee the authoring, preparing and compiling of high quality,

submission-ready CMC documentation for HA submissions in Seqirus

territories.

Ensure compliance of CMC regulatory dossiers with manufacturing and quality control processes.

Support global CMC regulatory and change control policies and procedures

Provide strategic regulatory expertise and guidance for the development and

review of technical protocols and reports (e.g. assay development, validation, stability, product development)

Provide regulatory direction to address inspectional findings and support CAPA projects as applicable.

Actively contribute to the global Seqirus regulatory community through

designated projects.

Work closely with the Global Head, CMC & Compliance to develop and maintain an effective Global Regulatory Affairs organisation through continuous

improvement initiatives that deliver business excellence.

Contribute to the budget preparation and manage resource plans and monitor progress of the Regulatory team to ensure strategic objectives for the site are achieved

Deputise for Holly Springs Site Head, CMC & Compliance as required

Develop collaborative and respectful relationships with staff at National Human Medicines Regulatory Agencies within the Region & represent Seqirus at

meetings with these Regulatory Agencies

Knowledge, Skills & Competencies & Quals

Excellent strategic and tactical thinking ability

Demonstrated ability to lead, influence and motivate a team

A balanced technical understanding of products and processes combined with business, regulatory and compliance acumen

Ability to establish credible relationships within Seqirus and externally, including with Regulatory Authorities and Distributors/Agents in the Region.

Demonstrated sound judgement and flexible approach to managing situations

Effective delivery of objectives in a complex matrix environment

Ability to deal with rapid change

Strong verbal & written communication skills in a cross functional environment

Excellent presentation skills

Attention to detail

Excellent project management skills

Proactively owns and drives assigned tasks to completion

Proactively develops solutions and maximises opportunities ahead of time

Develops effective contingency plans

Strong negotiation skills with internal and external stakeholders

Extensive and proactive commercial awareness with evidenced application to regulatory strategies

Excellent customer focus with demonstrated management of customer

expectations and anticipating customer needs

Demonstrated ability to take measured risks with overall positive outcome for the business

7-10 years’ regulatory experience with extensive knowledge and experience CMC Regulatory Affairs.

Experience in biologicals is advantageous.

Masters or PhD, or complementary experience in the pharmaceutical/ biotechnology industry highly desirable

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Senior Manager RA - CMC & Compliance