Associate Director Regulatory Affairs

Associate Director, Regulatory Affairs CMC - 57043

The opportunity:

The RA CMC Associate Director provides leadership, strategy and guidance to regulatory CMC teams supporting Teva’s production site in Kfar Saba Israel.

The role is responsible for development and implementation of professional standards, streamlined harmonised processes, and to manage the day-to-day activities of the RA CMC teams in line with site priorities and business strategies.

Our global RA CMC team is committed to achieving excellence through harnessing expertise and promoting collaboration, driving compliance and streamlining processes. We foster high-performing teams by embracing Teva’s leadership principles and maintaining an enterprise mindset within the balanced matrix.

How you’ll spend your day:

• Planning & Coordination:
• Plan and delegate functional activities, ensuring resources are available.
• Prioritize and coordinate daily tasks of assigned staff and time-critical regulatory activities.
• Regulatory Expertise:
• Collaborate with RA CMC, local site teams and cross-functional teams, on project strategies and compliance throughout the product lifecycle.
• Provide advice and expertise on regulatory issues and strategies for submissions and post-approval changes in various markets.
• Collaboration & Networking:
• Build networks within and outside the organization to support objectives.
• Promote cross-team collaboration and leverage skills to advance company goals.
• Encourage a collaborative way of working, leveraging available knowledge and skills to support Teva’s overall objectives and success.
• Compliance:
• Follow ICH guidelines, GMP, and internal SOPs; stay updated on industry regulations.
• Maintain and update SOPs and participate in the Change Control System.
• Ensure proper document archiving and database maintenance.
• Keep up to date with regulatory and other developments in the pharmaceutical industry, including relevant legislation and guidelines (all regions), pharmacopoeias and suggest appropriate changes to processes and policies as needed.
• Resource & Performance Management:
• Manage team headcount and recruitment, set goals, provide feedback, and support staff development.
• Implement company policies, ensure staff training, and maintain clear job description
• KPIs: Monitor and report on functional Key Performance Indicators.

Your experience and qualifications:

• University degree in the field of Science, e.g. Chemistry. Advanced degree (M.Sc., Ph.D.) is preferred.
• Minimum of 8-10 years of experience in regulatory affairs or compliance within the pharmaceutical industry, with at least 3-5 years in a leadership role.
• Practical experience in RA CMC
• Practical experience in assessing and writing CTD sections of Registration dossiers