Senior Manager, RA Submissions

ndly impact health for humanity. Learn more at https://https://www.jnj.com

Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Product Submissions and Registration
Job Category:
People Leader
All Job Posting Locations:
Bucureşti, Romania, Leiden, Netherlands, Mechelen, Antwerp, Belgium, Warsaw, Masovian, Poland
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 https://https://www.jnj.com/innovative-medicine

We are seeking 3 Senior Managers, RA Submissions to be located in: USA (Raritan, NJ or Titusville, NJ) or EMEA (Turnhoustseweg, Belgium; Allschwil, Switzerland; High Wycomb, Great Britian; Leiden, Netherlands; Warsaw, Poland or Bucuresti, Romania)

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:

• Advanced knowledge of the product development process, CTA, regulatory affairs; knowledge of industry standards and trends, and internal submission requirements.

• Knowledge of regulatory information management systems and tools.

• Knowledge of global CTA regulations.

• Effective therapeutic area and product knowledge.

• Effective interpersonal, teamwork, and communication skills.

• Knowledge of people management and leadership processes.

• Ability to work or lead in a matrix environment.

• Project management and submission management capabilities.

• Skill in problem solving and troubleshooting.

• Proficiency in submission related HA and Industry regulations and guidelines as relevant.

You will be responsible for:

• Manages a team of CTA specialists in the planning and preparation and maintenance of regulatory submissions and filings. Provides guidance to project team members. Is responsible for performance oversight, development, and accountability of staff.

• Manages and leads team in all HR processes including the 5 Conversations.

• Leads the coaching and development process for team and other colleagues.

• Leads others and holds staff accountable to the application of appropriate regulatory submission standards, requirements, processes and policies to comply with applicable health agency requirements.

• Analyzes and prioritizes team workload and assignments. Ensures submission events are tracked using appropriate systems/tools.

• Directs the submission operational strategy in line with regulatory strategy as applicable.

• Takes a leadership role to ensure that all required documents are included in the dossier and that submission events/activities are tracked in appropriate systems/tools.

• Takes a leadership role in the development of departmental work practices, process enhancements and or improvements.

• Actively participates in CTA leadership team discussions and decision making.

• Ensures and maintains openly, timely and effective communications with all partners and staff to ensure timely deliverables.

• Ensures effective interactions with key partners to ensure priority conflicts, resource issues, and deviations from the plan are identified and resolved. Removes obstacles as needed. Partners across GRA and functional area contributing groups as needed for assigned projects.

• May be responsible for performing submission work (submission management).

• Contributes to the management of budget and resources for assigned organization and manages work to achieve budget goals.

Education and Experience Requirements:

• Bachelor's 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

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, Poland and Bucuresti, Romania -Requisition #: R-017935

• 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 ([email protected]) or contact AskGS to be directed to your accommodation resource.