Senior Manager, Regulatory Affairs Device (Hybrid)

Role Summary

The Senior Manager, Regulatory Affairs, Device works with internal and external partners to deliver products to patients. Prepares device regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations, and Research & Development (R&D) organizations. Represents RA Device on teams such as product development, Global Regulatory Product Teams, and Operations brand teams to negotiate, influence, and provide strategic advice. This individual will support the Eyecare Therapeutic Area.

Responsibilities

• Prepares device regulatory product strategies. Prepares and manages regulatory submissions, including new applications and amendments, renewals annual reports, supplements and variations, and responds to regulatory information.
• Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions.
• Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies.
• Responds to global regulatory information requests.
• Develops strategies for device agency meetings, manages preparation for agency meetings, and manages content of pre-meeting submissions.
• Manages products and change control with an understanding of regulations and company policies and procedures. Analyzes and approves manufacturing change requests.
• Represents RA Device on teams such as the product development, Global Regulatory Product Teams, and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions.
• Stays abreast of regulatory procedures and changes in regulatory climate. Analyzes legislation, regulation and guidance, provides analysis to the organization.
• Develops, implements, and documents policies and procedures within the regulatory affairs department. Participates in initiatives internal to RA Device.

Qualifications

• Required Education: Bachelor‚Äôs Degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject.
• Preferred Education: Relevant advanced degree preferred. Certification a plus.
• Required Experience: 8 years pharmaceutical experience
• Preferred Experience: 10 years pharmaceutical experience including 5-plus years in regulatory affairs or 5-plus years in Discovery, R&D, or Manufacturing.
• Experience developing and implementing successful global regulatory strategies and working in a complex and matrix environment.
• Strong oral and written communication skills.

Skills

• Knowledge of ISO/CE process and global product registration process. Experience with eCTD tools and EDMS applications.
• Knowledge of global regulatory intelligence and policy to analyze external regulatory trends and internal compliance trends to drive proactive initiatives to ensure compliance for Device/Combination Products.
• Understanding of device/combination product regulations (21 CFR Parts 3, 4, GCP, GLP, 210/211, 820 QSR, MDR/IVDR, ISO 13485, MDSAP, and other global regulatory requirements for Allergan‚Äôs devices and combination products).

Education

• Details provided in Qualifications above.