Senior Regulatory Affairs Professional

Responsibilities

• Participate in global and regional regulatory team meetings and advise the regulatory team on applicable regulatory requirements, project‑specific regulatory issues as assigned.
• Develop an understanding of the regional regulatory environment, competitor intelligence, and therapeutic area.
• Assist in the preparation of meetings and act as backup for contact with Regulatory Agencies as needed.
• Ensure responses to Regulatory Agency queries are made in a timely manner, and that content is consistent with the regulatory strategy.
• Work cross‑functionally, interact with internal and external colleagues with coordination between departments, and lead team meetings as appropriate.
• Advise team in required documents and submission strategies.
• Review clinical trial plans, protocols and submission plans ensuring alignment with regulatory requirements.
• Support the development and improvement of processes related to regulatory submissions.
• Provide regulatory input for and follow‑up to inspections, audits, litigation support, and product complaints.
• Stay on top of current and pending approvals in assigned therapeutic areas and be knowledgeable of laws, guidelines and requirements related to those areas.
• May interact with Health Authorities (HA) regarding program‑specific issues and serve as secondary HA point‑of‑contact to represent J&J/Janssen externally with some degree of supervision.

• Pharm D/PhD with 2-5 years’ experience OR Masters with 3-5 years of experience is required.
• Understanding of the drug development process.
• Previous experience in a health regulated industry preferred.
• Understanding of regulatory submission and approval process and applicable US and EMA regulatory guidelines.
• Relevant regulatory affairs experience in pharmaceutical/biotech.
• Experience responding to HA requests, managing HA interactions, and life cycle management applications.
• Diverse therapeutic area experience.
• Experience with in a cross‑functional team environment as an individual contributor and decision maker.
• Proactively anticipates issues; exercises judgment in developing new approaches/solutions and resolving issues.
• Influences or persuades others within area of immediate responsibility, scope, and level to accept new ideas, practices, and approaches.
• Skilled at project managing and effectively prioritizing assignments for multiple projects simultaneously.
• Strong interpersonal and communication skills.