Johnson & Johnson Careers
Lead Associate, Regional Regulatory Submission Management
Requisition ID: 1905750767W
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines,cardiovascular and metabolic diseases and pulmonary hypertension. Please visit http://www.JanssenRnD.com for more information.
Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information.
The Lead Associate, Regulatory Submission Management will:
- Be responsible for the submission operational management and delivery of regulatory submissions across multiple products and TAs to support the development, registration, and compliance in the assigned countries/ region
- Coordinate and compile Dossier Plans/Submission Packages in line with regulatory strategy. As a member of regional dossier team(s), seek input from regulatory global dossier teams, therapeutic and functional area representatives, regional and/or country representatives and other key stakeholders. while providing guidance to project team members.
- Ensure timely delivery of high-quality dossiers (working with partners to manage content, format, timelines) whilst maintaining appropriate records and oversight in applicable systems and tools.
- Lead regional and/or country-specific Submission Team meetings to coordinate the preparation and maintenance of regulatory submissions and filings for the assigned products and countries. Monitor the effectiveness of the dossier process and identify improvement opportunities.
- Lead and/or participate in special projects and process improvement initiatives; contribute to country-specific regulatory submission intelligence gathering and maintenance
- Where appropriate, provide component- level publishing support for regulatory-owned deliverables in PDF format to ensure dossier components conform to submission standards.
- Utilize current electronic document management systems/tools and/or publishing technologies to assemble and publish dossiers according to regulatory requirements for paper and electronic submissions, with a high degree of independence.
- Apply appropriate regulatory submission standards, requirements, processes, and policies to comply with applicable health agency requirements.
- Cultivate ongoing effective relationships within GRA as well as cross-functionally. Works with partners to communicate and resolve issues/ concerns with submission timelines.
- A minimum of a Bachelor’s Degree in combination with a minimum of 6 years of relevant/related professional experience OR a Masters/PharmD/PhD in combination with a minimum of 1 year of relevant/related professional experience is required
- Experience associated with managing global Marketing Applications (e.g., NDA/BLA/MAA/NDS) is required
- Experience managing Marketing Applications for emerging markets (ie: AsiaPac, LATAM, Middle East/Africa, etc.) is highly preferred
- In-depth understanding of drug development process is required
- Demonstrated project or submission management capabilities is highly preferred
- Previous experience leading Submission Team meetings to coordinate the preparation and maintenance of regulatory submissions and filings is highly preferred
- Ability to work or lead in a matrix environment required
- Demonstrated ability to build productive relationships and work with stakeholders across an organization required
- Knowledge of relevant submission-related Health Authority and Industry regulations and guidelines is required
- Ability to use Regulatory Information systems required
- This role will be located in Europe/Middle East/ Africa: Beerse, Belgium; Leiden, The Netherlands; or High Wycombe, England and may require up to 5% travel, domestic and international.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability
Janssen Biologics (7266)