Senior Manager, North America Regulatory Liaison

Johnson & Johnson • Titusville, NJ

1d • Hybrid

About The Position

Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Manager, North America Regulatory Liaison. 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.

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
• group legal insurance
• consolidated retirement plan (pension)
• savings plan (401(k))
• long-term incentive program
• 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

What This Job Offers

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