Project Manager III
Global RA CMC Lead, Regulatory Affairs CMC
The Associate Director/Director Regulatory Affairs Global RA CMC Lead, Regulatory Affairs CMC, works with internal and external partners in order to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including clinical applications and marketing applications. Represents CMC on teams to negotiate, influence, and provide strategic advice. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Demonstrates understanding of drug development and leadership behaviors consistent with level.
• Identifies and collects data needed and prepares CMC regulatory product strategies. Seeks expert advice and technical support as required for strategies and submissions.
• Manages the preparation of CMC submissions. Prepares and manages regulatory applications, including new clinical applications and amendments, market applications, renewals, annual reports, supplements/variations under limited supervision. Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies.
• Manages products and change control in compliance with regulations and company policies and procedures. Analyzes and approves manufacturing change requests.
• Develops strategies for CMC meetings, support/manage preparation for agency meetings and content of pre-meeting submissions.
• Regularly informs regulatory management of important timely issues.
• Represents CMC regulatory affairs on teams such as the product development and Global Regulatory Product Teams, for assigned projects; negotiates with and influences team members to maximize chances for first pass approval or regulatory submissions.
• Supports combination products and medical devices including design control and change management activities
• Required Education: Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering or related
• Preferred Education: Relevant advanced degree is preferred.
• Required Experience:
• 8 years pharmaceutical or industry-related experience. Some portion should include experience related to pharmaceutical
regulatory work. Proven 3+ years in a leadership role with strong management skills.
• Experience working in a complex and matrix environment with multiple stakeholders and on cross-functional teams.
• Strong communication and proactive negotiation skills, both oral and written.
Experience interfacing with government regulatory agencies. Experience developing and
implementing successful global regulatory strategies.
• Preferred experience:
• 5 years’ experience in Regulatory Affairs; 10 years pharmaceutical experience (drug/medical device/combination product). 5 years in Discovery, R&D or Manufacturing
• Experience developing and implementing successful global regulatory strategies. Experience working with Health Authority
• Note: Higher education may compensate for years of experience.