Manager, Regulatory Affairs Submissions

6084-Janssen Research & Development Legal Entity

Job Location:

Titusville, FL - USA

Monthly Salary: $ 100000 - 172500

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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:

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:

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 is recruiting for a Manager RA Submissions. The position can be located in Springhouse PA Titusville NJ or Raritan NJ. The position will manage Clinical Trial Applications as a member of the Next Generation Submissions (NGS) organization.

Key Responsibilities:

Be responsible for the operational management and delivery of global clinical trial regulatory submissions.
Create and handle dossier plans/submission packages in line with clinical trial regulatory strategy
Support decision making impacting the quality and timeliness of Clinical Trial Health Authority submissions
Make decisions on clinical trial submission operational strategies for the best project management approach within process/timeline/resource constraints.
Lead Clinical Trial Submission Team meetings to coordinate the preparation and maintenance of regulatory submissions and filings.
Take a leadership role for the monitoring and efficiency of the submission process and initiate changes within the scope of decision-making authority to minimize inefficiencies and ensure / improve quality.
Cultivate effective relationships maintaining open communication with key partners to ensure priority conflicts resource issues and deviations from the plan are identified and resolved.
Develop departmental work practices process enhancements / improvements and associated training materials
May be responsible for performance and development of direct reports.

Qualifications Experience and Skills:

University/bachelors degree and 6 years of related professional experience or
Masters/PharmD/PhD in combination with 4 years of relevant/related professional experience
In-depth understanding of drug development process
Ability to demonstrate in-depth knowledge of clinical trials regulatory submissions filings and processes
Ability to work and lead in a matrix environment
Proven ability to build positive relationships and influence stakeholders across an organization
Proficiency in relevant clinical trials submission-related Health Authority and Industry regulations and guidelines
Proficient use of Regulatory Information Systems
Fluency in English; other languages may be required depending on assignment.
Project / submission management proficiencies
Previous experience leading Clinical Trial Submission Team meetings to coordinate the preparation and maintenance of submissions and filings

Other

May lead and/or contribute to special projects and participate in process improvement initiatives.
May require up to 5% travel domestic and international.

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-037131
Switzerland- Requisition #: R-042460
Belgium Netherlands and Poland- Requisition #:R-042463
UK- Requisition #: R-042464

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:

Coaching Compliance Management Continuous Improvement Design Thinking Package and Labeling Regulations Process Improvements Product Packaging Design Quality Assurance (QA) Regulatory Affairs Management Regulatory Compliance Standard Operating Procedure (SOP) Strategic Thinking Sustainability Sustainable Packaging Technical Credibility Transparency Reporting

The anticipated base pay range for this position is :

$100000-$172500

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:

Manager