Sr. Regulatory Affairs CMC Manager

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Nov 22, 2021
Ref
R-145468
Required Education
Doctorate/PHD/MD
Position Type
Full time
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 portfolio.

Your key accountabilities 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.
  • Mentor junior colleagues and support their growth and professional development
  • 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

To be successful in this role, you will have:

  • A degree in Biological Science, Allied Medical discipline or Pharmacy; preferably with a Masters or PhD, or complementary experience in the pharmaceutical/ biotechnology industry.
  • 7-10 years’ regulatory experience with extensive knowledge and experience CMC Regulatory Affairs. Experience in biologicals is Advantageous
  • 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 along with excellent presentation skills
  • Excellent project management skills
  • Strong negotiation skills with internal and external stakeholders
  • Extensive and proactive commercial awareness with evidenced application to regulatory strategies

About Us

Our Benefits

Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.

About Seqirus

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.

We want Seqirus to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.

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