Senior Manager, North America Regulatory Liaison

Johnson & Johnson Innovative Medicine • Hopewell Township, NJ

3d • Hybrid

About The Position

This position is a hybrid role and can be located in Titusville, NJ; Raritan, NJ; or Spring House, PA. The Senior Manager, North America Regulatory Liaison, will be responsible for leading the end-to-end planning, coordination and execution of assigned deliverables. Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Requirements

• A minimum of a Bachelor’s degree in a scientific or technical discipline is required.
• A minimum of 8 years of relevant Regulatory Affairs experience in pharmaceutical, biotech or consumer over the counter (OTC) industry is required.
• A minimum of 8 years of relevant regulatory experience with a Bachelor’s degree; a minimum of 6 years of relevant regulatory experience with a Master’s or PharmD degree; or a minimum of 4 years of relevant regulatory experience with a Ph.D. is required.
• Knowledge of clinical drug development is required.
• Experience working with the U.S. FDA and global regulatory Health Authorities (HAs) is required.
• Experience responding to FDA and other HA requests and managing HA interactions is required.
• Experience in lifecycle management of IND/NDA/CTA/MAA and other regulatory submissions is required.
• Demonstrated experience in critically reviewing and compiling regulatory documents is required.
• Must have excellent communication and interpersonal skills.
• Must have strong organization and time management skills.
• Must have the ability to exercise independent judgment and execution in anticipating, evaluating and resolving complex functional and/or complex organizational issues with novel solutions.
• Must have strong leadership capabilities with the ability to work successfully in a matrixed environment.
• The ability to effectively prioritize assignments for multiple products and projects simultaneously is required.
• The ability to collaborate with all levels and influence decision-making within a cross-functional organization is required.

Nice To Haves

• Advanced degree (Master’s, PharmD, Ph.D.) in a scientific or technical discipline preferred.
• Experience in the Neuroscience therapeutic area is preferred.
• Experience in people management/coaching/mentoring is preferred.

Responsibilities

• Key contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory applications and managing procedures through approvals.
• In collaboration with the global regulatory team, develop global submission plans and Health Authority interaction plans.
• Lead and/or contribute to the planning, preparation (including authoring where relevant) and delivery of both simple and complex submissions throughout the product’s life cycle from either a global and/or regional perspective.
• Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
• Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s).
• Provide strategic regulatory input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents.
• Understand the regulatory framework, including regional trends, for various types of applications and procedures across all regions.
• Collaborate with cross-functional submission delivery teams.
• Participate and coordinate Health Authority interactions by leading regulatory team members and cross-functional team members.
• Serve as primary point-of-contact to Health Authority.
• If necessary, this position may work as Regional Regulatory Leader.
• May represent Johnson & Johnson or company externally with limited supervision.
• May cultivate and leverage strategic networks and partnerships.
• Demonstrate the ability of strategic thinking and contingency planning with respect to corporate objectives.
• Demonstrate effective critical thinking, including problem solving and goal setting for improved efficiency.

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)).
• long-term incentive program.
• Vacation - 120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Washington - 56 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior