Job Posting Title Associate Director, RA Submissions

Job title:

Job Posting Title Associate Director, RA Submissions

Company:

Johnson & Johnson

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at https://www.jnj.comJob Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory Product Submissions and RegistrationJob Category:
ProfessionalAll Job Posting Locations:
Beerse, Antwerp, Belgium, Leiden, NetherlandsJob Description:About Innovative MedicineOur 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://www.jnj.com/innovative-medicinePlease 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):US (Titusville, NJ; Raritan, NJ; Horsham, PA) – Requisition Number: 2506229584WHigh Wycombe, UK – Requisition Number: R-009929Allschwil, Switzerland – Requisition Number: R-009934Beerse, Belgium and Leiden, Netherlands – Requisition Number: R-009938Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.We are searching for the best talent for Associate Director, RA Submissions.You will be responsible for:Depending on the project and assigned submission(s), required activities may include, but may not be limited to:

• Develop and maintain a regulatory submission operational strategic plan for assigned products, influencing strategic submission management and publishing considerations for global registration filings.
• Coordinate dossier planning and execution of the global operational submission strategy in alignment with Global Regulatory Team (GRT) and Global Filing and Launch Strategy (GFLS) goals to ensure delivery of initial and major applications through both direct leadership and appropriate delegation.
• Creation and management of complex Dossier Plans for registration submissions, primarily focusing on the US and EU, based on in-depth knowledge and expertise, seeking input from regulatory therapeutic areas, functional area representatives, publishing partners, and key stakeholders. Ensure that all required documents are included in the dossier and perform a review of the published output.
• Act as the Subject Matter Expert (SME) on, and key point of contact for, global registration dossiers for assigned products, providing insights on product dossier plan details, context, and submission history to cross-functional partners and other submission managers executing regional submissions.
• Serve as a member of the Global Regulatory Team (GRT), ensuring the transfer of relevant information between GRT, Submission Working Group (SWG), Global Dossier Team (GDT), and Product Care Team (PCT).
• Maintain effective interactions with relevant partners to ensure identification of risks, priority conflicts, resource issues, and develop mitigation strategies relative to the scope of their responsibilities.
• Ensure relevant submission processes are applied to all submissions, providing guidance to internal and external partners as needed, and coordinate with dossier level publishing partners to achieve production of regulatory submissions that conform to regional and country specific regulatory requirements.
• Monitor the efficiency of submission processes with responsibility for initiating changes within the scope of decision-making authority to minimize inefficiencies and ensure quality.
• Meet regularly with submission collaborators to identify and resolve issues with the quality and delivery of, Dossier Plans, component deliverables, and timelines against established critical metrics.
• Track submission events/activities in appropriate systems/tools.

Qualifications / Requirements:

• A minimum of Bachelor’s degree or equivalent experience in a related field (Pharmacy, Life Sciences, Regulatory Affairs, etc.)
• A minimum of 8 years of experience in regulatory affairs, submission management, or a related field.
• In-depth understanding of the pharmaceutical product development process.
• Proficiency in the use of Regulatory Information Systems, and submission planning and publishing tools
• Proficiency in global submission-related Health Authority regulatory requirements and guidelines
• Proficiency in English; other languages may be required depending on assignment.
• Demonstrated excellent communication and interpersonal skills.
• Proven track record in leading cross-functional teams and influencing strategic decisions.
• Demonstrated ability in problem solving, trouble shooting, decision making, and adaptability.
• Ability to lead teams and work effectively with partners in a fast-paced, matrixed, and dynamic environment.
• May require travel, both domestic and international, of up to 5%.

Expected salary

Location

Leiden, Zuid-Holland

Job date

Thu, 17 Apr 2025 22:38:26 GMT

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