Sr Scientist Product Lead CMC RA
Johnson & Johnson Innovative Medicine
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Benefits offered by this job
Job summary
Johnson & Johnson Innovative Medicine is seeking a Senior Scientist Product Lead CMC RA - Synthetics, New Modalities to support East Coast USA locations, Beerse (Belgium) or Warsaw (Poland).
The role focuses on leading global CMC regulatory strategies, coordinating dossiers and regulatory submissions, and guiding cross-functional teams to ensure compliance and timely approvals across development programs.
Qualifications
- BS in biological, pharmaceutical, chemical or engineering sciences with generally a minimum of 6+ years of experience.
- An MS, Ph.D., or Pharm. D. degree preferred.
- Demonstrated ability to communicate regulatory requirements.
- Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry.
- Prior drug development, analytical development, or manufacturing experience.
- Strong attention to detail with high-level verbal and written communication skills.
Responsibilities
- Contributes to the development of global CMC regulatory strategies and dossier plans.
- May participate as the Regulatory CMC Lead on CMC Teams and provide regulatory expertise to enable global product development.
- Supports global regulatory filings for development compounds and potentially marketed products.
- Prepares regulatory dossiers for submission to Health Authorities under supervision.
- Coordinates and manages CMC country-specific documents for global submissions.
- Assists in developing and preparing CMC Health Authority responses as needed.
- May participate in selected initiatives within CMC RA / GRA.
- Drives a culture of continuous improvement to ensure regulatory compliance and communicates critical issues to Management.
Skills
Education
Tools
Job description
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Discovery & Pre-Clinical/Clinical Development
Regulatory Science
Scientific/Technology
Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America
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.
- Contributes to the development of global CMC regulatory strategies and dossier plans according to scientific/risk-based principles in collaboration with other Global CMC Regulatory Affairs (CMC RA) personnel.
- May participate as the Regulatory CMC Lead on CMC Teams and represent CMC RA by providing regulatory expertise on the CMC Core Team and Global Regulatory Team (GRT) to facilitate successful product development globally and to provide input on team recommendations.
- Supports global regulatory filings for mainly development compounds, and potentially also marketed products, in collaboration with other CMC RA senior personnel.
- Prepares regulatory dossiers for submission to Health Authorities under supervision.
- Coordinates, compiles, and manages CMC country specific documents required as part of the approval process for global submissions.
- Assists in developing and preparing CMC Health Authority responses as needed according to the proposed strategy.
- May participate in selected initiatives within CMC RA / GRA.
- Drives a culture of continuous improvement to ensure compliance with Johnson and Johnson standards, regulatory requirements and expectations. Communicates critical issues to Management.
- May contribute to the development/implementation of global CMC regulatory strategies and dossier plans for development compounds (and marketed products).
- Ensures the CMC regulatory strategy is in alignment with the strategies of global regulatory affairs, the therapeutic area, commercial, regional functions and the Quality Target Product Profile (QTPP).
- Assures connectivity to the overall global regulatory strategy through partnership and communication with Therapeutic Area Regulatory Affairs (Global Regulatory Leader) or other senior level CMC RA personnel.
- Provides input to and assists in the preparation of dossiers for submission to Health Authorities (NDA/BLA /MAA/IND/CTA and post approval variations).
- Assists in providing accurate regulatory assessments of CMC changes to teams for execution of regulatory planning and implementation.
- Escalates issues to CMC RA Management that affect registration, regulatory compliance and continued lifecycle management of the product.
- Assists in execution or development of contingency plans for issues that affect registration, regulatory compliance, and continued lifecycle management of the product.
- Provides CMC Regulatory support to health authority inspections.
- BS in biological, pharmaceutical, chemical or engineering sciences with generally a minimum of 6+ years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent. An MS, Ph.D., or Pharm. D. degree preferred.
- Demonstrated ability to communicate regulatory requirements.
- Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry.
- Prior drug development, analytical development, or manufacturing experience.
- Strong attention to detail with high-level verbal and written communication skills.
- Communicates cross-functionally and cross-company. Presents and defends CMC management-approved regulatory strategy and opinion to project teams.
- Demonstrates model behavior that understands what the priorities are and encourages others to drive for results.
- Experience interacting with Health Authorities under supervision of a senior member of the CMC RA staff.
- Working knowledge of global HA laws, regulations and guidances.
Beerse (Belgium), Warsaw (Poland) - Requisition Number: R-097794
$109,000.00 - $174,800.00
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
This position is eligible to participate in the Company’s long-term incentive program.
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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