Associate Director, Regulatory Affairs CMC

The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (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 managers content strategy for regulatory submissions, including new marketing applications, supplements and variations. Builds and maintains relationships within the regulatory affairs functional areas, Operations and Research and Development (R&D) organizations. Represents CMC on teams such as product development, Global Regulatory Product Teams and Operations brand teams to negotiate, influence, and provide strategic advice. Serves as liaison and strategic partner with the regulatory agencies (e.g. FDA). Manages assigned projects within assigned resources. May supervise others.

Key Responsibilities Include :

• 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 applications and amendments, renewals, annual reports, supplements and 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, manage preparation for agency meetings and manages content of pre-meeting submissions. Serves as the point of contact for the regulatory agency meetings.
• Regularly informs regulatory management of important timely issues.
• Trains, develops and mentors individuals; may include formal supervisory responsibilities.
• Develops and implements policies and procedures within the regulatory affairs department.
• Analyzes legislation, regulation and guidance and provides analysis to the organization.
• Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members to maximize chances for first pass approval or regulatory submissions.
• Represents CMC regulatory affairs on project initiatives with other groups to drive efficiencies across the company.
• Supports combination products and medical devices including design control and change management activities

Basic:

• Required Education: Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
• Preferred Education: Relevant advanced degree preferred.
• Required Experience: 8 years pharmaceutical or industry related experience. Proven 3+ years in a leadership role with strong management skills
• Experience working in a complex and matrix environment.
• Strong communication skills, both oral and written.
• 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

Equal Opportunity Employer Minorities/Women/Veterans/Disabled