Senior Manager, RA Submissions
Senior Manager, RA Submissions
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1 Vacancy
Job Description
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 GroupJob Sub Function:
Regulatory Product Submissions and RegistrationJob Category:
People LeaderAll Job Posting Locations:
High Wycombe Buckinghamshire United KingdomJob 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 3 Senior Managers RA Submissions to be located in: USA (Raritan NJ or Titusville NJ) or EMEA (Turnhoustseweg Belgium; Allschwil Switzerland; High Wycombe Great Britian; Leiden Netherlands)
Purpose:
The Senior Manager RA Submissions is a member of the CTA Leadership team and provides direct supervision to the CTA team responsible for the delivery of compliant regulatory submissions required to support the development and registration of products. This position supervises CTA staff at global locations and at multiple levels and drives achievement of team results. This position may be responsible for performing additional project or submission related work based on area of responsibility. The Senior Manager RA Submissions makes decisions that impact CTA submissions that will be viewed by external authorities. This position makes decisions on strategies within process/timeline constraints and appropriate deviations from normal practice to meet unique challenges in the most efficient manner. The Senior Manager contributes to decisions on department guidelines standards processes and resourcing. This position is charged with making decisions associated with the management of assigned personnel and local administration including hiring and performance management. The Senior Manager RA Submissions focuses on both short- and medium-term (1-2 years) needs of the department and their deliverables. This position may provide guidance to cross-functional teams about submissions strategy processes and timing. This position requires the ability to make decisions and resolve issues with limited supervision. The Senior Manager makes decisions for project and non-project staff assignments and resourcing. This position exercises independent judgment and execution in anticipating interpreting evaluating and resolving complex organizational issues. This position keeps the supervisor apprised and solicits management support as needed.
The Senior Manager RA Submissions must have knowledge of:
- 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.
You will be responsible for:
- 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 and Raritan NJ - Requisition #: R-016928
- Beerse Belgium; Leiden Netherlands; Warsaw
- High Wycombe Great Britain- Requisition #: R-017931
- Allschwil Switzerland- Requisition #: R-017932
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 Experience:
Senior Manager
Employment Type
Full-Time
