Regulatory Compliance Officer at Transport for NSW conducting investigations and audits for third party programs. Ensuring compliance with regulatory schemes and engaging with relevant programme participants.
About the role
- Senior Regulatory Affairs Scientist at Johnson & Johnson supporting regulatory compliance in drug development. Collaborating across functions to ensure adherence to regulations in healthcare innovation.
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 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
Requirements
- 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
- 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 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
Benefits
- medical, dental, vision, life insurance
- short- and long-term disability
- business accident insurance
- group legal insurance
- consolidated retirement plan (pension)
- savings plan (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
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