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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.
Job Function:
Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function:
Regulatory ScienceJob Category:
Scientific/TechnologyAll Job Posting Locations:
Beerse, Antwerp, Belgium, Warsaw, Masovian, PolandJob Description:
Job Description
About Innovative Medicine
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.
Learn more at https://www.jnj.com/innovative-medicine
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 Beerse, Belgium or Warsaw, Poland.
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 pay range for this position, in the primary posting location, is:
€72,500.00 - €115,230.00The anticipated pay ranges for additional locations are:
Poland - The anticipated base pay range for this position is 163,000 - 262,200 PLN
Benefits:
In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.
Skills Required
- Bachelor's degree in biological, pharmaceutical, chemical, engineering, or related scientific discipline
- Master's degree, PharmD, or Ph.D.
- At least 4 years of related pharmaceutical or healthcare industry experience, including postgraduate 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 CMC Regulatory Affairs supervision
- Working knowledge of global health authority laws, regulations, and guidance
- Ability to present and defend CMC regulatory strategy and opinions to project teams
- Ability to communicate regulatory requirements to cross-functional and cross-company stakeholders
- Excellent verbal and written communication skills
- Strong attention to detail
Johnson & Johnson Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.
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Healthcare Strength — Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
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Retirement Support — Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
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Parental & Family Support — Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.
Johnson & Johnson Insights
What We Do
Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines
