The Senior RA Manager, Regions role is a leadership role within the Regional regulatory team. The role contributes to the vision and goals for Global Regulatory Affairs and Seqirus, by providing regional strategic advice and support to Project/Product teams, Regions Commercial Operations and Business Development teams.
The role interfaces with other functions in Regulatory Affairs (e.g. Global Strategic Labelling, Regulatory CMC & Compliance, Regulatory Operations & Compliance,) and across the organization in Clinical, Medical, Pharmacovigilance, Commercial Operations and Business Development, etc 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, Regions will influence, lead and execute the regulatory strategy for one or more 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, Regions will 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 within the region (e.g. EMA, CBER, TGA). The Senior Manager, Regions will represent the company at external regulatory agency meetings as relevant to the project or product portfolio.
A degree in Biological Science, Allied Medical discipline or Pharmacy; preferably with a Masters or PhD, or complementary experience in the pharmaceutical/ biotechnology industry
At least 10 years of regulatory Strategy experience with extensive knowledge and experience of US regulatory affairs.
Experience in biologicals is advantageous.
Line management experience advantageous
Internal Number: R-074693
Seqirus is different - a new company with a long history.
A clear vision for fighting disease in the 21st century, driven by more than 100 years of experience in combatting influenza and other serious diseases. Seqirus is empowered by the global strength of our parent company, CSL Limited. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day.