Senior Regulatory Affairs Program Lead
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that's reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs from the pediatric to aging eye in a patient's lifetime.
Your unique talents will help patients on their journey to wellness.
Purpose : A strategic, leadership role managing regulatory activities across product development and lifecycle, providing independent guidance, leading submissions, and overseeing compliance efforts. Responsible for developing regulatory plans, guiding cross-functional teams, and managing complex regulatory projects. May have direct supervisory responsibilities for contract resources or employees.
You will be responsible for :
- Managing regulatory strategies for product development and lifecycle management.
- Providing independent regulatory guidance to product teams.
- Leading complex international and domestic submissions and approvals.
- Overseeing conformance with regulations in claims, labeling, and promotion.
- Developing and approving regulatory documentation, including labeling and advertising.
- Coordinating and monitoring regulatory project schedules and deliverables.
- Guiding the development of regulatory policies and best practices.
- Supporting regulatory audits, inspections, and compliance programs.
- Managing and influencing relationships with health authorities.
- Overseeing and mentoring regulatory team members or vendors.
- Ensuring alignment of regulatory activities with corporate strategic goals.
- Tracking global regulatory trends and implementing proactive strategies.
- May provide supervision and direction to contract resources or employees.
Qualifications / Requirements :
Minimum of a Bachelor's Degree required, Advanced Degree highly desired; desired areas of study include Science, Engineering, or related field.Minimum of 6+ years of related Regulatory Affairs experience (4+ years with Advanced Degree); Medical Device regulatory experience strongly preferred.Experience with Vision related medical device regulatory highly desired.Working knowledge of US FDA & EU MDR regulatory requirements & processes required.A demonstrated track record of developing and driving implementation of regulatory strategies.Working knowledge of how global regulations impact product registration.Good communication skills for effective collaboration with cross-functional partners.Corresponding and collaborating with J&J colleagues globally for strategic contribution and achievement of regulatory milestones.Evaluating new regulatory requirements as well as regulatory changes and correctly assessing business impact.Excellent verbal and written communication skills; strong attention to detail.Advanced analytical and problem-solving skills.High organization skills with the ability to lead multiple projects / tasks simultaneously and effectively prioritize projects and tasks.Strong learning skills for complex technology and presentation skills to allow presentation of complex regulatory strategies in a clear, concise, and comprehensive fashion.This position will require up to 10% travel.Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https : / / www.jnj.com / contact-us / careers or contact AskGS to be directed to your accommodation resource.