Regulatory Affairs Director
hace 1 mes
As a Regulatory Affairs Associate Director at Sandoz, you will lead a team of associates within the Regulatory API (RAPI) department. Your primary responsibility will be to drive and deliver high-quality documentation to support successful submissions, adhering to agreed timelines and project plans. This includes preparing registration documentation and assessing the appropriateness of registration documentation for active ingredients/intermediates.
Key Responsibilities- Lead, coach, and mentor associates to ensure sufficient training and development opportunities, maximizing regulatory competence.
- 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, ensuring compliance with current global regulatory standards.
- Formulate and drive global regulatory strategy, balancing business benefit with regulatory compliance.
- Generate, review, and approve internal regulatory guidance documents, protocols, and reports within assigned projects.
- 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 and for new technical trends.
- Transfer knowledge and experiences to the organization.
- Liaise with regulatory agencies and represent the company in regulatory meetings and discussions.
- PhD in a natural science (chemistry, pharmacy, biology, or related substances) with at least 3 years of work-related post-doctoral/industrial experience or Master/BSc in a natural science with at least 3 years of work-related experience, including people management experience.
- Leadership experience within the regulatory affairs function.
- Broad knowledge of Module 3 and regulatory guidelines.
- Good knowledge of relevant software tools.
- Good skills in presentation and scientific/technical writing.
- Good documentation skills and ability to understand and follow written procedures.
- Fluent oral and written English and Spanish.
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