Principal Scientist, CMC Regulatory Affairs Combination Products (1 of 2)

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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:

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:

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 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-093413

• Belgium Poland - Requisition Number: R-094873

• Switzerland - Requisition Number: R-094883

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 Principal Scientist CMC Regulatory Affairs - Combination Products. This position is a hybrid role and can be located in Raritan NJ; Titusville NJ; Spring House PA; or Horsham PA.

The Principal Scientist CMC Regulatory Affairs - Combination Products role will provide CMC (Chemistry Manufacturing and Controls) regulatory subject matter expertise for drug-device combination products and related device constituent parts involved in the preparation or administration of drugs. This role may support pre-approval and post-approval programs synthetic or biologic products and products in any therapeutic area.

The Principal Scientist will develop and execute regulatory strategies for assigned combination product programs submissions Health Authority interactions and lifecycle management activities. This individual may serve as a core member of the combination product development team and may serve as an ad hoc member of the CMC team (or Value Chain team for post-approval programs) and Global Regulatory Team. This role will also support successful development registration and lifecycle management of combination products globally.

This individual will provide subject matter expertise regarding global combination product and global medical device regulatory requirements and is expected to consult with other medical device regulatory experts within Johnson & Johnson Innovative Medicine or Johnson & Johnson MedTech as needed. The role will apply in-depth regulatory and scientific knowledge to address complex issues involving one or more related disciplines establish operational plans for assigned responsibilities provide guidance to technical and cross-functional colleagues and contribute to business results through effective regulatory execution.

Principal Responsibilities:

• Provide regulatory expertise and interpretation of global combination product and global medical device regulatory requirements including evolving global Health Authority CMC expectations for drug-device combination products their user interface and devices integral or separate involved in the preparation or administration of drugs.

• Develop and execute regulatory strategies for clinical marketing and lifecycle management submissions involving combination products including regulatory risk assessments and mitigation plans.

• Review device and combination product-specific submission content for clinical trial applications marketing applications Notified Body technical dossiers and development and review of applicable design control deliverables.

• Provide regulatory assessments for manufacturing device and product changes and determine regulatory impact globally.

• Develop regulatory strategies for Health Authority interactions briefing books and responses related to combination product regulatory questions.

• Participate in cross-functional initiatives related to regulatory process improvements guidance implementation and capability development.

• Monitor emerging global device and combination product regulations and communicate regulatory impacts to project teams and management.

• Perform other duties in support of Global Regulatory Affairs CMC Regulatory Affairs combination product development registration lifecycle management regulatory compliance and organizational capability-building objectives. These activities may include participation in selected due diligence internal consultation process improvement training and cross-functional regulatory initiatives.

Qualifications:

Education:

• A minimum of a Bachelors degree or equivalent in a scientific engineering pharmaceutical regulatory science or related discipline is required. Advanced degree (Masters PharmD Ph.D) in a scientific engineering pharmaceutical regulatory science or related discipline is preferred.

Required:

• A minimum of 8 years of relevant experience in Regulatory Affairs Quality and/or Product Development inclusive of post-graduate education.

• Experience in the pharmaceutical biotechnology medical device combination product or other regulated healthcare environment.

• Knowledge of scientific technical regulatory or product development principles relevant to regulated healthcare products.

• The ability to develop and execute regulatory strategies for assigned programs submissions Health Authority interactions or lifecycle activities.

• The ability to collaborate cross-functionally and influence decision-making across a global matrix organization.

• Excellent written and verbal communication skills.

• Strong analytical problem-solving skills.

• Strong attention to detail and organizational skills

• 10% domestic or international travel

Preferred:

• Understanding of drug-device combination product development processes including design control concepts risk management principles human factors/usability engineering principles quality management system principles lifecycle management activities and associated regulatory requirements.

• Experience supporting development registration or lifecycle management of pharmaceutical biologic medical device and/or drug-device combination products.

• Experience supporting global regulatory submissions Health Authority interactions Notified Body interactions and device-related CMC submission content is preferred.

• Knowledge of global regulatory requirements and frameworks applicable to drug-device combination products and medical devices including FDA combination product regulations and guidance documents (e.g. 21 CFR Part 4) Quality Management System Regulation (QMSR) EU Medical Device Regulation (EU MDR) and related global guidance documents.

• Understanding of how device and combination product requirements are integrated into pharmaceutical or biologic product development regulatory submissions and lifecycle management activities.

• The ability to interpret and apply regulatory requirements to support scientifically sound risk-based regulatory strategies.

• Regulatory Affairs Certification (RAC).

Johnson & Johnson is an 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 disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

Preferred Skills:

Benchmarking Coaching Consulting Corporate Governance Critical Thinking Drug Discovery Development Fact-Based Decision Making Healthcare Trends Interpersonal Influence Organizing Public Policies Regulatory Compliance Regulatory Development Scientific Research Strategic Thinking Subject Matter Experts (SME) Collaboration Technical Writing

The anticipated base pay range for this position is :

$117000.00 - $201250.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Companys 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: - Experience:

Staff IC