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Associate Director CMC Regulatory Affairs Lead
2 months ago
We are seeking an experienced Associate Director CMC Regulatory Affairs to lead our site Regulatory Affairs function and customer-related RA CMC compliance activities.
Key Responsibilities- Regulatory Leadership: Provide strategic guidance and oversight to the site Regulatory Affairs team, ensuring compliance with regulatory requirements and industry standards.
- CMC Regulatory Expertise: Develop and implement CMC regulatory strategies, ensuring alignment with company policies and procedures.
- Regulatory Support: Provide regulatory support and advice to internal and external customers, including preparation and review of regulatory documents and submissions.
- Team Management: Mentor, coach, and lead direct reports, including performance appraisals, objectives, and development planning.
- Regulatory Intelligence: Stay up-to-date with regulatory requirements and industry developments, providing insights and recommendations to the team.
- Collaboration: Work collaboratively with cross-functional teams, including quality, operations, and commercial, to ensure regulatory compliance and alignment.
- Communication: Develop and maintain effective communication with customers, stakeholders, and internal teams, ensuring clear understanding of regulatory requirements and expectations.
- Education: Bachelor's degree in Life Science or related field.
- Regulatory Experience: Advanced regulatory CMC experience in managing complex biotechnology dossier programs, complex regulatory projects, and regulatory intelligence.
- Leadership Skills: Proven leadership and management skills, including team management, coaching, and mentoring.
- Communication Skills: Excellent communication and interpersonal skills, with ability to develop and maintain effective relationships with customers, stakeholders, and internal teams.
- Regulatory Knowledge: In-depth knowledge of regulatory requirements and industry standards, including CMC regulations and guidelines.
As a member of the Lonza Group Ltd. team, you will have the opportunity to work with a global leader in life sciences, contributing to the development of innovative products and solutions that improve lives around the world.
We offer a comprehensive benefits package, including performance-related bonus, medical and dental coverage, 401k plan, life insurance, short-term and long-term disability insurance, an employee assistance program, paid time off (PTO), and more.
Lonza is an equal opportunity employer, committed to diversity and inclusion. We welcome applications from qualified candidates who share our values and are passionate about making a difference in the life sciences industry.
