Regulatory Affairs Associate Director
hace 4 semanas
Job Title: Regulatory Affairs Associate Director
Job Summary:
As a Regulatory Affairs Associate Director at Sandoz, you will lead a team of regulatory professionals in driving and delivering high-quality documentation to support successful submissions. Your responsibilities will include leading, coaching, and mentoring associates, ensuring sufficient training and development opportunities, and taking responsibility for financial targets. You will also ensure timely and accurate reporting of regulatory activities, analyze group performance, and make recommendations for improvement. Additionally, you will coordinate the preparation and execution of regulatory documents, formulate and drive global regulatory strategy, and establish and maintain sound working relationships with colleagues, partners, and customers.
Key Responsibilities:
- Lead, coach, and mentor associates to ensure regulatory competence
- Ensure sufficient training and development opportunities for associates
- Take responsibility for financial targets, including cost center responsibility
- Ensure timely and accurate reporting of regulatory activities
- Analyze group performance and make recommendations for improvement
- Coordinate the preparation and execution of regulatory documents
- Formulate and drive global regulatory strategy
- Establish and maintain sound working relationships with colleagues, partners, and customers
- Provide regulatory guidance to cross-functional teams and determine regulator impact for changes in chemistry, manufacturing, and control procedures
- Support or lead global regulatory projects/initiatives
- Keep knowledge up to date regarding regulatory guidelines and requirements in all global regions
- Responsibility for transfer of knowledge and experiences to the organization
- Liaise with regulatory agencies and represent the company in regulatory meetings and discussions
- Work according to internal and external guidance's, SOPs, and respective timelines
Requirements:
- PhD (natural science: chemistry, pharmacy, biology, or related substances) with at least 3 years of work-related post-doctoral/industrial experience or Master/BSc (natural science: chemistry, pharmacy, biology, or related substances) with at least 3 years of work-related experience, including people management experience
- Leadership experience within regulatory affairs function
- Broad knowledge on Module 3
- Broad knowledge of regulatory guidelines
- Good knowledge of relevant software tools
- Good skills in presentation and scientific/technical writing
- Good documentation skills and able to understand and exactly follow written procedures
- Fluent oral and written English
- Fluent Spanish
About Sandoz:
Generic and Biosimilar medicines are the backbone of the global medicines industry.
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