Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Regulatory Science
Job Category:Scientific/Technology
All Job Posting Locations: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
Job Description: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):
- United States - Requisition Number: R-100114
- Belgium, Poland - Requisition Number: R-101274
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Scientist, Product Lead CMC Regulatory Affairs - Synthetics, New Modalities. This position is a hybrid role and can be located in Titusville, NJ; Raritan, NJ; Spring House, NJ; or Horsham, PA.
The Senior Scientist Product Lead CMC Regulatory Affairs - Synthetics, New Modalities will be responsible for the following:
- Drive scientific strategy and critical decision-making through integration of disease biology, pharmacology, biomarkers, human genetics, and clinical data.
- Contribute to the development of global CMC (Chemistry, Manufacturing, and Controls) 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.
- Support global regulatory filings for mainly development compounds, and potentially also marketed products, in collaboration with other CMC RA senior personnel.
- Prepare 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.
- Assist in developing and preparing CMC Health Authority responses as needed according to the proposed strategy.
- May participate in selected initiatives within CMC RA/GRA.
- Drive a culture of continuous improvement to ensure compliance with Johnson & Johnson standards, regulatory requirements and expectations. Communicate critical issues to Management.
- May contribute to the development/implementation of global CMC regulatory strategies and dossier plans for development compounds (and marketed products).
- Ensure 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).
- Assure 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.
- Provide input to and assists in the preparation of dossiers for submission to Health Authorities (NDA/BLA /MAA/IND/CTA and post approval variations).
- Assist in providing accurate regulatory assessments of CMC changes to teams for execution of regulatory planning and implementation.
- Escalate issues to CMC RA Management that affect registration, regulatory compliance and continued lifecycle management of the product.
- Assist in execution or development of contingency plans for issues that affect registration, regulatory compliance, and continued lifecycle management of the product.
- Provide CMC Regulatory support to health authority inspections.
Qualifications:
Education
- A minimum of a Bachelor's degree in Biological, Pharmaceutical, Chemical or Engineering Sciences or a related scientific discipline is required. Advanced degree (Master's, PharmD, Ph.D.) preferred.
Required:
- A minimum of 4 years of related pharmaceutical or health care industry experience, inclusive of post graduate education.
- Solid understanding of biology, chemistry and/or engineering, relevant to the pharmaceutical industry.
- Prior drug development, analytical development, or manufacturing experience.
- Experience interacting with Health Authorities independently or under the supervision of CMC Regulatory Affairs staff.
- Working knowledge of global Health Authority laws, regulations and guidances.
- The ability to present and defend CMC management-approved regulatory strategy and opinion to project teams.
- The ability to demonstrate model behavior that understands what the priorities are and encourages others to drive for results.
- The ability to communicate regulatory requirements to stakeholders cross-functionally and cross-company.
- Excellent verbal and written communication skills.
- Strong attention to detail.
#LI-Hybrid
Required Skills:Preferred Skills:Analytical Reasoning, Coaching, Communication, Compliance Risk, Consulting, Controls Compliance, Corporate Governance, Critical Thinking, Data Governance, Drug Discovery Development, Healthcare Trends, Public Policies, Regulatory Compliance, Regulatory Development, Relationship Building, Scientific Research, Technical Writing, Technologically Savvy
The anticipated base pay range for this position is :$109,000.00 - $174,800.00
Additional Description for Pay Transparency:
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)).
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
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
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
