Associate Director, Regulatory CMC Dossier
Your job alert was successfully created.
Janssen Research & Development L.L.C., a member of the Johnson & Johnson Family of Companies, is recruiting for an Associate Director, Regulatory CMC Dossier, located in Spring House, PA, Malvern, PA, Titusville, NJ, Raritan, NJ, or potential to work remotely within the US.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.
We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
• The Associate Director Regulatory CMC Dossier will represent Dossier Development and Operations group on matrix CMC development teams, providing direction and guidance on CMC dossier preparation and global filings.
• Responsible to manage the development of CTD Quality sections to support Regulatory CMC dossier applications. Provides technical oversight and authoring of the CMC dossier (Modules 2 and 3) of global marketing and clinical trial submissions, including global Health Authority responses.
• Develops the submission timeline, creates and manages eCTD documents, sets the dossier strategy, authors scientific content, and orchestrates the review and internal approval of content. Uses their scientific knowledge and technical writing skills, in conjunction with strong project management skills, to drive the timely completion of high-quality submissions across the various platforms and modalities in Janssen R&D portfolio.
• Keeps abreast of evolving global regulatory guidance. Provides interpretation of relevant CMC guidances (ICH, FDA, EMA, etc) and ensures ongoing alignment of dossier content with the latest regulatory expectations.
• Assumes personal ownership and accountability for business results and solutions; consistently delivers high quality results. Mentors junior staff in the development of dossiers.
• Consistently meets and sometimes exceeds the minimum competency standard to proactively sense and respond to problems and opportunities; works to enable continuous improvement and reduce cycle times for key deliverables; proactively takes action when needed.
• PhD with 6+ years relevant experience, MS with 10 years of relevant experience, or a BS with 12 years of relevant experience
• Strong technical background in chemistry, biology, engineering, pharmaceutics or related fields. Broad knowledge of pharmaceutical drug development functions and processes.
• Demonstrated experience in writing and preparation of regulatory CMC filings and associated technical reports and documentation.
• Detailed working knowledge of global CMC regulatory requirements for pharmaceuticals and demonstrated ability to apply them to author high quality CMC regulatory filings.
• Outstanding interpersonal, communication, negotiation, and writing skills. Proven ability to manage and deliver complex projects in a matrix team environment.
• Excellent verbal and written communication skills are required.
• A minimum of 3 years of direct experience in leading global CMC dossier preparation activities.
• Large molecule experience
• May require up to 10% domestic and international travel.
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.
United States-Pennsylvania-Spring House-
North America-United States, North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Malvern
Janssen Research & Development, LLC (6084)