Regulatory Associate

About the Job

The Regulatory Associate will report to the Regulatory Manager and will be responsible for managing products under development and/or marketed products

Roles and Responsibilities

• According to the Blue Print initiative, Develop regulatory strategy and provide regulatory expertise within project/product teams for products under development and/or marketed products
• Interface with various project/product teams. /
• Coordinate dossier and briefing package preparations according to the plans (new registration and maintenance) and monitoring dossiers up to implementation.
• Ensures optimal support to key stakeholders to deliver on-time high quality dossiers in compliance with Health Authority requirements.
• Liaise with HA contact person; organizing and preparing HA meeting and attending as appropriate together with Business Unit Regulatory Manager.
• Manage the maintenance of a portfolio of products.
• Provide support and communicating information on products to other functions (approvals, ...).
• Review and validate at country level promotional material with Marketing and Medical in line with Global strategies and policies.
• In liaison with his/her manager, can be involved in activities such as shortages, DHPC, B/R reevaluation, recall etc.
• Support the consolidation and provision of regulatory expertise and giving input about requirements and needs.
• Follow regulatory changes, competitor’s status and assess potential impact on daily activities and project strategy.

Main Requirements

• Degree in medicine, pharmacy, chemistry sciences or other relevant life sciences
• Minimum 3-6 years’ experiencein similar positionin different types of registrations, preferably in multinational organization
• Project management experience in the pharmaceutical industry or in a regulatory environment. Recognized expert in managing matrix teams

Skills

• Negotiation & communication skills
• Organization skills and high accuracy in documentation
• Knowledge of new decrees & guidelines
• Multitasker
• Promptness in respond to authorities requirements and prompt in deliverables / Otoritelerin gerekliliklerine anında cevap verme ve hızlı teslim
• Problem solving and interpersonal skills

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!