Senior Manager, RA Submissions

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

Job Function :

Regulatory Affairs Group

Job Sub Function :

Regulatory Product Submissions and Registration

Job Category : People Leader

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 :

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 are seeking Senior Manager RA Submissions to be located Raritan NJ Titusville NJ or Spring House PA.

Job requirements :

Strong leadership capabilities with proven experience in managing direct reports mentoring junior staff and fostering a collaborative work environment.

Proven understanding regulatory requirements related to Clinical Trial Applications including ICH-GCP EMA and other relevant guidelines.

Demonstrated experience leading and managing the preparation review and submission of CTAs to regulatory bodies.

Exceptional analytical skills to identify potential issues analyze complex data and develop effective solutions in a fast-paced regulatory environment.

Effective verbal and written communication skills with the ability to liaise confidently with internal teams and external partners.

Bachelors Degree or higher in Life Sciences Pharmacy Regulatory Affairs or a related field.

Strong organizational skills with the ability to manage multiple submissions and regulatory deadlines simultaneously.

Ability to work or lead in a matrix environment.

Key Responsibilities

Lead and oversee a CTA team in planning preparing and maintaining regulatory submissions and filings ensuring accuracy and compliance throughout the process. Provide guidance and support for direct reports to facilitate smooth submission workflows.

Manage all HR-related processes for the team including performance management development and fostering a positive work environment. Ensure team members are aligned with organizational goals and standards.

Drive the coaching and professional development of team members and colleagues promoting continuous improvement skill enhancement and a high-performance culture.

Maintain and promote up-to-date expertise on global and regional regulations ensuring all submissions meet current guidelines standards and best practices.

Provide leadership and oversight to the CTA team ensuring the application of appropriate regulatory submission standards processes and policies to ensure compliance with regulatory agencies.

Analyze team workload prioritize assignments and oversee the tracking of submission activities using relevant systems and tools to ensure timely delivery.

Lead the development and alignment of submission operational strategies with overarching regulatory strategies ensuring coherence and efficiency.

Drive continuous improvement by leading the development and enhancement of departmental work practices processes and workflows.

Actively participate in CTA leadership team meetings contributing strategic insights and supporting decision-making processes.

Ensure open timely and effective communication channels with all stakeholders and team members to facilitate smooth project execution and meet deadlines.

Foster strong collaborations with key partners to proactively identify and resolve conflicts related to priorities resource allocation or deviations from plans removing obstacles to ensure project success. Collaborate across GRA functions and relevant groups as needed for assigned projects.

Education and Experience Requirements :

Bachelors degree and 8-10 years of overall experience required

7 years of relevant industry experience; Masters / Pharm D / PhD with 6 years experience preferred

People or team management experience required

Global CTA regulations knowledge and experience required

Project leadership experience required

Prior senior leadership experience preferred

Can work a hybrid schedule that includes work from home flexibility as well as a regular in-office requirement at one of the locations listed in the next section

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s) :

Titusville NJ; Raritan NJ; or Springhouse PA - Requisition # : R-040598

Switzerland - Requisition # : R-042491

Belgium Netherlands and Poland - Requisition # : R-042494

UK- Requisition # : R-042495

Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.

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 and 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 email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

Required Skills : Preferred Skills :

Compliance Management Cross-Functional Collaboration Design Thinking Developing Others Inclusive Leadership Leadership Operational Excellence Package and Labeling Regulations Process Improvements Product Packaging Design Regulatory Affairs Management Regulatory Compliance Risk Assessments Standard Operating Procedure (SOP) Strategic Thinking Sustainability Sustainable Packaging Team Management Transparency Reporting

The anticipated base pay range for this position is :

$120000-$207000

Additional Description for Pay Transparency :

Subject to the terms of their respective plans employees and / or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs : medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance. 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 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 Additional information can be found through the link below. Experience :

Senior Manager

Key Skills

Program Management,FDA Regulations,Management Experience,Facilities Management,Clinical Development,Data Management,Quality Systems,Project Management,Research & Development,GLP,Budgeting,Leadership Experience

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 120000 - 207000