Senior Manager, North America Regulatory Liaison

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Raritan New Jersey United States of America Spring House Pennsylvania United States of America Titusville New Jersey United States of America

Job Description:

About Innovative Medicine

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.

Learn more at & Johnson Innovative Medicine R&D is recruiting for a Senior Manager North America Regulatory Liaison. This position is a hybrid role and will be located in Spring House PA; Titusville NJ; or Raritan NJ.

The Senior Manager North America Regulatory Liaison will serve as a strategic regulatory leader driving North America regulatory strategy and execution for assigned Immunology projects. This role will partner closely with global and cross-functional leaders to shape development pathways influence key decisions and ensure high-quality timely interactions with Health Authorities. The position will require a strategic mindset balancing risk mitigation with opportunity maximization to enable successful Immunology product development and lifecycle management.

The Senior Manager North America Regulatory Liaison will be responsible for leading the end-to-end planning coordination and execution of assigned deliverables.

Principal Responsibilities:

Regulatory Strategy & Leadership:

• Contribute to and help shape regulatory submission strategies identifying risks mitigation plans and opportunities.

• Provide strategic regulatory input into key development documents (e.g. clinical protocols study reports summaries).

• Apply knowledge of regional and global regulatory frameworks trends and requirements across all phases of development.

Submission Planning & Execution:

• Lead the planning preparation and delivery of regulatory submissions (simple to complex) across the product lifecycle.

• Develop and maintain submission delivery timelines content plans and execution strategies.

• Author and/or critically review submission components ensuring quality and compliance.

• Manage regulatory applications and associated procedures through Health Authority approvals.

Health Authority Engagement:

• Serve as primary point of contact with Health Authorities (e.g. FDA).

• Lead and coordinate Health Authority interactions including preparation of briefing materials and responses.

• Manage responses to regulatory queries and requests.

Cross-functional Collaboration:

• Partner with global regulatory and cross-functional teams to align on submission and interaction plans.

• Lead or contribute to cross-functional submission teams to ensure timely and effective execution.

• Communicate clear proactive status updates to stakeholders.

Operational Excellence & Influence:

• Identify and drive process improvements applying critical thinking and problem-solving skills.

• Demonstrate strategic thinking including contingency planning aligned with business objectives.

• Influence decision-making across a matrixed organization.

Representation & Networking:

• Represent the company externally with Health Authorities and industry partners as appropriate.

• Build and leverage strategic relationships and networks.

Additional Scope:

• May serve as Regional Regulatory Leader for assigned programs.

Qualifications:

• A minimum of a Bachelors degree in a scientific or technical discipline is required. Advanced degree (Masters PharmD Ph.D.) in a scientific or technical discipline preferred.

• A minimum of 8 years of relevant regulatory experience with a Bachelors degree; a minimum of 6 years of relevant regulatory experience with a Masters or PharmD degree; or a minimum of 4 years of relevant regulatory experience with a Ph.D. is required.

• Experience in pharmaceutical biotech or OTC industry is required.

• Strong knowledge of clinical drug development and regulatory pathways is required.

• Experience managing lifecycle submissions (e.g. IND NDA CTA MAA) is required.

• Demonstrated experience preparing reviewing and delivering regulatory documentation is required.

• Proven track record interacting with FDA and other global Health Authorities is required.

• Experience in Immunology therapeutic area preferred.

• Experience in people management/coaching/mentoring is preferred.

• Must have excellent communication and interpersonal skills.

• Must have strong stakeholder management skills.

• Must have the ability to exercise independent judgment in resolving complex regulatory and organizational challenges.

• 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.

• This position may 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 external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

Preferred Skills:

Analytical Reasoning Business Writing Compliance Risk Fact-Based Decision Making Industry Analysis Legal Support Mentorship Organizing Product Licensing Public Policies Regulatory Affairs Management Regulatory Compliance Regulatory Development Regulatory Environment Risk Assessments Strategic Thinking Technical Credibility

The anticipated base pay range for this position is :

$137000.00 - $235750.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).


This position is eligible to participate in the Companys long-term incentive program.


Subject to the terms of their respective policies and date of hire employees are eligible for the following time off benefits:

Vacation 120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado 48 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

Bereavement Leave 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave 80 hours in a 52-week rolling period10 days

Volunteer Leave 32 hours per calendar year

Military Spouse Time-Off 80 hours per calendar year


For additional general information on Company benefits please go to: - Experience:

Senior Manager