Amsterdam Area, Netherlands, Amsterdam, Netherlands
Are you looking for a rewarding career in a market-leading and innovative company?
Seqirus is the new global company created from the combined strength and expertise of bioCSL and the influenza vaccines business formerly owned by Novartis. In July 2015, bioCSL and the influenza vaccines of Novartis joined forces to create Seqirus, now the second largest influenza vaccine company in the world. With extensive research and production expertise and manufacturing plants in the US, UK, Germany and Australia, Seqirus is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. Seqirus has a workforce of over 2,000 employees, significant manufacturing capacity and a commercial presence in 20 countries.
Will ensure that all regulatory agency correspondence and all submissions are filed within the relevant documentation management systems or regulatory databases, so that regulatory commitments are tracked to ensure that across the business we maintain regulatory compliance, and furthermore as a business we are not exposed to non-compliant findings from external Human Medicines Regulatory Agency Inspections (i.e. FDA, EMA, MHRA, PEI & TGA etc.).
• Support the development and implementation of the global regulatory strategy for development products/programs
• Contribute to the ongoing regulatory risk assessment of development strategies
• Assist in the planning, preparation, review and submission of high quality applications including IND, BLA/MAA, regulatory agency briefing documentation and responses to questions.
• Support Global Strategic Labelling in the development of product labelling (PI, CMI, SmPC, PIL etc.)
• Assist in providing regulatory expertise and guidance for the development and review of technical (e.g. assay development, validation, stability, product development) and clinical protocols and reports
• Collaborate with Regions colleagues to ensure dossiers meet content requirements for applicable territories
• Monitor Regulatory Agency and ICH Websites to build and develop a strong understanding of the regulatory requirements for the region
• Deputise for Senior/Principal RA Scientist when required
• Ensure that RA submissions and approvals are updated in the RA tracking database and that internal company stakeholders are aware of submissions status, approvals and commitments
• Under direction of manager, ensure that submissions are clear, well written and communicate the company position accurately
• Contribute to a culture of continuous improvement and accountability
• Actively contribute to the global CSL regulatory community through designated projects
• Build and maintain relationships with Global Regulatory Affairs colleagues across the Seqirus company as appropriate to role
• 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 12 months of regulatory affairs experience, or related biologicals/ pharmaceutical industry experience
• Demonstrable experience of effective delivery of objectives in a complex global matrix environment;
• Demonstrated ability to collaborate and influence
• Demonstrated ability to deal with rapid change
• Customer service focus
• Demonstrated sound judgement and flexible approach to managing situations
• Strong planning, organising and time management skills
• Strong problem solving and analytical skills
• Effective verbal and written communication skills in a cross functional environment
• Attention to detail
• Computer literacy
• Ability to establish credible relationships within Seqirus and externally
Seqirus is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.