Senor Scientist, Product Lead CMC Regulatory Affairs

7555-Janssen Pharmaceutica NV Legal Entity; Geel; Hybride; EUR 73 000 - 115 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Résumé du poste

Johnson & Johnson is recruiting a Senior Scientist, Product Lead CMC Regulatory Affairs - Synthetics, New Modalities. This hybrid role can be located in Beerse, Belgium or Warsaw, Poland.

You will drive strategy, manage regulatory dossiers, and coordinate global submissions with cross-functional teams across regulatory, development, and health authorities. You will contribute to global CMC regulatory strategies, lead on teams when needed, and ensure alignment with Therapeutic Area and corporate

Qualifications

• Bachelor’s degree in Biological, Pharmaceutical, Chemical or Engineering Sciences or a related scientific discipline.
• Advanced degree (Master’s, PharmD, Ph.D.) preferred.
• Minimum 4 years of related pharmaceutical or health care industry experience.

Responsabilités

• Drive scientific strategy and decision-making through integration of biology, pharmacology, biomarkers, human genetics, and clinical data.
• Develop global CMC regulatory strategies and dossier plans with Global CMC Regulatory Affairs (CMC RA) personnel.
• May participate as the Regulatory CMC Lead on CMC Teams and provide regulatory expertise on the CMC Core Team and Global Regulatory Team.
• Support global regulatory filings for development compounds and potentially marketed products.
• Prepare regulatory dossiers for submission to Health Authorities under supervision.
• Coordinate, compile, and manage CMC country-specific documents for global submissions.
• Assist in developing and preparing CMC Health Authority responses and participate in initiatives within CMC RA/GRA.

Connaissances

Analytical Reasoning

Coaching

Communication

Compliance Risk

Regulatory Development

Regulatory Compliance

Relationship Building

Scientific Research

Technical Writing

Regulatory Strategy

Formation

Bachelor’s degree in Biological, Pharmaceutical, Chemical or Engineering Sciences or a related scientific discipline

Advanced degree preferred

Description du poste

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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.

Job Function

Discovery & Pre-Clinical/Clinical Development

Job Sub Function

Regulatory Science

Job Category

Scientific/Technology

All Job Posting Locations

Beerse, Antwerp, Belgium; Warsaw, Masovian, Poland

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.

Responsibilities

• 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 Experience

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.

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

Pay Range

The anticipated pay range for this position, in the primary posting location, is: €72,500.00 - €115,230.00

The anticipated pay ranges for additional locations are: Poland - The anticipated base pay range for this position is 163,000 - 262,200 PLN

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.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 https://www.jnj.com/.