CSL Plasma
CMC Regulatory Affairs Manager
At a glance
Location: US-NC-Holly Springs Map
Posted: 06/09/2021
Closing: 07/08/2021
Degree: Not Specified
Type: Full-Time
Experience: At least 7 year(s)
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 Regulatory Affairs Manager CMC; is responsible for leading the coordination, prioritization and tracking of regulatory activities and CMC submissions associated with the company’s research, development and post-marketing activities for a variety of therapeutic areas.

Responsibilities include:

  • Foster effective and productive communication among various cross-functional groups including Regional Regulatory Leads, , Labelling, Quality, Technical Development, Operations and representatives from other functional areas, as appropriate, via proactive networking and facilitation of the Project Team.
  • Develop and maintain detailed timelines for global regulatory activities and submissions for assigned CMC projects and ensure these timelines are adhered to.
  • Ensure planning and coordination of activities to support regulatory submissions via the Regulatory Submission Team. 
  • Work with Regulatory Regional leads to ensure that submissions are prepared in line with ICH requirements, other local or regional regulatory requirements, as applicable, and company policies and procedures. 
  • Track regulatory commitments and timelines for maintenance activities such as Post Marketing Commitments and Follow-up Measures, and ensuring appropriate submissions are made in accordance with applicable requirements and deadlines.
  • Work closely with the RA CMC Global Head to develop and maintain an effective Global Regulatory Affairs organisation through continuous improvement initiatives that deliver business excellence.
  • Identify opportunities and contribute to the growth and professional development of direct reports (if applicable)
  • Actively contribute to the global Seqirus regulatory community through designated projects
  • Contribute to budget preparation and resource planning

Qualification, Skills and Experience: -

  • A degree in Biological Science, Medical discipline or Pharmacy, or complementary experience in the pharmaceutical/ biotechnology industry.
  • 7+ years relevant experience; experience in both Regulatory Affairs and Project Management is preferred. Experience in biologicals is advantageous.
  • Effective delivery of objectives in a complex matrix environment
  • Ability to deal with rapid change
  • Effective verbal & written communication skills in a cross functional environment
  • Attention to detail
  • 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
  • Excellent presentation skills

CMC Regulatory Affairs Manager