Regulatory Affairs Associate Director
hace 1 mes
Job Summary:
As a Regulatory Affairs Associate Director at Sandoz, you will lead a team of regulatory professionals responsible for ensuring compliance with global regulatory standards. Your expertise in regulatory affairs will drive the development and implementation of regulatory strategies to support the company's business goals.
Key Responsibilities:
- Lead a team of regulatory professionals to ensure compliance with global regulatory standards.
- Develop and implement regulatory strategies to support business goals.
- Coordinate the preparation and execution of regulatory documents.
- Ensure regulatory CMC submissions are of high quality, consistent, and complete.
- Formulate and drive global regulatory strategy to maximize business benefit balanced with regulatory compliance.
- Generate, review, and approve internal regulatory guidance documents, protocols, and reports.
- Establish and maintain sound working relationships with colleagues, partners, and customers.
- Provide regulatory guidance to cross-functional teams and determine regulatory impact for changes in chemistry, manufacturing, and control procedures.
Requirements:
- PhD in natural science (chemistry, pharmacy, biology, or related substances) with at least 3 years of work-related post-doctoral/industrial experience or Master/BSc in natural science with at least 3 years of work-related experience including people management experience.
- Leadership experience within regulatory affairs function.
- Broad knowledge of regulatory guidelines.
- Good knowledge of relevant software tools.
- Good skills in presentation and scientific/technical writing.
- Fluent oral and written English and Spanish.
About Sandoz:
Sandoz is a leader in the global medicines industry, touching the lives of almost 500 million patients last year. We have an ambition to do more and are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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