Associate QA Batch ReleaseAustraliëR-1317943085 Seqirus Pty
The Manager, Regulatory, GRA Region North America (GRA NA) is a member of a Regional Therapeutic Area Team and contributes to the vision and goals for Global Regulatory Affairs (GRA) by:
- Developing and leading the establishment and maintenance of high-quality relationships with regional health authorities and collaborating with respective GRA Global Regulatory Leads (GRLs) (Global Product Strategy or CMC) and internal stakeholders to enhance these relationships.
- May serve as the primary CSL Behring representative to regional health authorities for assigned products.
- Contributing to regulatory intelligence to account for changes in relevant regulations / laws impacting CSL Behring's business within the Region North America and providing regulatory assessment of these changes.
- Assuring a productive collaboration with key internal stakeholders, such as Regional commercial operations, to ensure successful development, strategic alignment and execution of regional regulatory strategies that result in successful applications for assigned products, from early development to Marketing Authorization (MA), and for any post MA submissions.
- Contributing regional regulatory perspective to the global regulatory strategy and aligning regional strategies with the global strategy throughout the product lifecycle for assigned products.
- Driving and executing comprehensive, commercially, and globally aligned regulatory activities within GRA NA for assigned products throughout development and after commercialization.
- Act as GRA NA representative for assigned projects to the Global Regulatory Affairs Strategy Team (GRAST) to provide regional input into the development and delivery of innovative, science-based, solution-oriented, and globally aligned regulatory strategy in conjunction with GRLs.
- Accountable for CSL Behring's relationship with respective health authorities (specifically CBER and CDER) for assigned products and negotiates with these authorities to achieve positive outcomes for CSL Behring. In support of this objective, works closely with the Regional Regulatory Therapeutic Area Lead (GRA NA TA Lead) in the preparation and conduct of FDA meetings, and leverages global GRA functions, as appropriate.
- Working closely with the GRA NA TA Lead, utilizes US regulatory affairs knowledge and experience, coupled with a global perspective, to ensure that emerging trends/issues are addressed and proactively influence the regional regulatory strategy in alignment with the global regulatory strategy.
- Work closely with the GRA NA TA Lead, to maintain an effective, globally minded, regulatory perspective that is focused on utilizing creative problem-solving skills, can clearly articulate the regional regulatory perspective to stakeholders and supports effective GRAST teams for assigned products.
- Executes comprehensive, commercially and globally aligned regulatory activities within Region for assigned products throughout development including timely and successful registration of new products and maintenance of existing products.
- Provides regional regulatory perspective, including health authority requirements, to assigned product GRASTs. In this forum, advocates and drives the 'one GRA' perspective with team stakeholders and actively supports GRAST activities.
- Participate in review and assessment of FDA draft guidance documents. Foster regulatory intelligence for assigned projects/therapeutic areas.
Your skills and experience
- A bachelor's degree in Science or Pharmacy. A post-graduate qualification is advantageous.
- Approximately 5 years of experience in the pharmaceutical industry, preferably in Biologics/Research & Development, some experience may be accounted for with advanced degree.
- Approximately 1-2 years of experience in regulatory, supported by additional pharmaceutical/industry experience.
- Awareness of regulatory guidelines and legislative requirements for US FDA.
- Experience in facilitating resolution of issues within a team environment with positive outcomes.
- Managing projects throughout a product's lifecycle utilizing past experience with health authorities and/or project teams.
- Experience working in a matrix environment including working with multiple stakeholders.
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