Sr. Regulatory Affairs Professional

Johnson & Johnson•Titusville, NJ

2d•Hybrid

About The Position

Johnson & Johnson is seeking a Sr. Regulatory Affairs Professional to support drug development programs and marketed products across multiple therapeutic areas. This role offers a flexible rotational model for broad and diverse regulatory experience, focusing on addressing business needs and individual career development goals. The position is ideal for early professional candidates looking to advance their careers in regulatory affairs within the Innovative Medicine sector. The role involves hands-on experience to enhance leadership, problem-solving, and creative thinking skills, while also developing business acumen for a complex regulatory environment.

Requirements

Pharm D/PhD with 2-5 years’ experience OR Masters with 3-5 years of experience is required.
This position is strictly suited for candidates with early professional experience who are looking to develop their careers in regulatory affairs.
Understanding of the drug development process.
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.

Nice To Haves

Previous experience in a health regulated industry.
Understanding of regulatory submission and approval process and applicable US and EMA regulatory guidelines.

Responsibilities

Participate in global and regional regulatory team meetings and advise the regulatory team on applicable regulatory requirements and project-specific regulatory issues.
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.
Ensure timely and consistent responses to Regulatory Agency queries, aligning with the regulatory strategy.
Work cross-functionally, interact with internal and external colleagues, coordinate between departments, and lead team meetings as appropriate.
Advise teams on required documents and submission strategies.
Review clinical trial plans, protocols, and submission plans to ensure 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 informed about current and pending approvals in assigned therapeutic areas and related laws, guidelines, and requirements.
May interact with Health Authorities (HA) regarding program-specific issues and serve as a secondary HA point-of-contact with supervision.

Benefits

Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Consolidated retirement plan (pension) and savings plan (401(k)).
Vacation –120 hours per calendar year.
Sick time - 40 hours per calendar year (56 hours for Washington State employees).
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.
Annual performance bonus.