Overview
Senior Regulatory Affairs Professional Jobs in Edison, USA at Jobtailor
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.
Requirements
- 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.
#J-18808-Ljbffr
Title: Senior Regulatory Affairs Professional
Company: Jobtailor
Location: Edison, USA
Category:
