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 is 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

Bachelor’s degree in a scientific or equivalent discipline + 6 years experience in academia or industry OR Pharm D/PhD + 2 years experience OR Masters +3 years of experience is required
Understanding of the drug development process
Preferred: Previous experience in a health regulated industry
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 within 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

medical
dental
vision
life insurance
short
and long-term disability
business accident insurance
group legal insurance
pension and savings plans (401(k))
vacation – 120 hours per calendar year
sick time
40 hours per calendar year
holiday pay, including Floating Holidays – 13 days per calendar year
work, personal and family time
up to 40 hours per calendar year
parental leave – 480 hours within one year of the birth/adoption/foster care of a child
condolence leave – 30 days for an immediate family member: 5 days for an extended family member
caregiver leave – 10 days
volunteer leave – 4 days
military spouse time-off – 80 hours

Senior Regulatory Affairs Scientist

Key skills