Sanofi
pharmaceutical or biotechnology
SeniorRegulatoryAffairsManager
“Senior Regulatory Affairs Manager at Sanofi. Skills: regulatory strategies, regulatory submissions, lifecycle management, health authority interactions, stakeholder management, leadership. developing, implementing and delivering regulatory strategies. influence policy”
What You'll Achieve.
deliver business priorities; optimal business outcomes; drive the strategic priorities; maximise business opportunities; achieve affiliate and corporate priorities; achieve business priorities; drive early submission and approvals; negotiate timely approvals; optimal product labelling and risk minimisation strategies; timely submission of post-approval variations; active discontinuation of unused registrations with no portfolio value; effective delivery of regulatory strategies; maintenance of compliance; meet required corporate and regulatory standards; serious injuries remain low; continuous reduction in the rate of incidents related to unsafe practices and unsafe conditions
Industry & Context.
risk minimisation strategies; risk assessment
What They're Looking For.
Must Have
Regulatory Affairs experience within the pharmaceutical or biotechnology industry, including regulatory submissions and lifecycle management, Experience working with TGA and/or Medsafe regulatory processes and health authority interactions, stakeholder management and cross-functional collaboration skills within matrix environments, Ability to independently manage complex regulatory activities with a strategic and execution-focused mindset, Leadership experience managing, mentoring, or coaching team members, Bachelor’s degree in Life Sciences, Pharmacy, or a related scientific discipline, Excellent communication and relationship-building skills
What You'll Do.
implementing and delivering regulatory strategies
accelerate access to new products
optimise the value of the existing product portfolio
Engagement with health authorities
influence the regulatory environment
Collaboration with local and global stakeholders
Implementation of the necessary quality systems
Investment in people development
develop and coach regulatory team
Conduct regular performance and development discussions
Ensure all relevant staff are aware of compliance obligations
Ensure brand team plans include optimal regulatory and risk minimisation strategies
Develop and maintain excellent relationships with health authorities
Monitor regulatory environment
Ensure continued regulatory compliance
Keep up to date with developments in regulatory affairs
Implement local regulatory risk assessment procedures
Manage regulatory review of promotional/non promotional materials
Ensure resources and outsource arrangements are managed
Ensure appropriate systems in place for tracking compliance
Ensure maintenance of regulatory quality system
Ensure audit readiness
Contribute to the development and maintenance of a safe working environment
Provide and maintain systems of work and working environments that are safe and without risks to health
Provide the information
training and supervision necessary to ensure the health and safety of employees
Consult with employees about HSE matters
Ensure the health and safety of people visiting or working who are not employees
Comply with corporate and legal health and safety requirements
Immediately notify any serious incidents
Undertake duties in accordance with the current Sanofi Policies and Procedures
How You'll Work.
Team & Collaboration
co-operating transversally through integrated brand planning; Collaboration with local and global stakeholders; alignment with key local and global stakeholders; collaboration with key local and global stakeholders; cross-functional collaboration skills within matrix environments
Communication Scope
Excellent communication and relationship-building skills; effective communication
Process & Methodology
integrated brand planning, strategic and execution-focused mindset
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