Sr Scientist Product Lead CMC RA

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.

We are searching for the best talent for a Senior Scientist Product Lead CMC RA - Synthetics, New Modalities to be in our Beerse (Belgium), Warsaw (Poland) or our East coast USA locations.

Principle responsibilities

• 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.

  

Sphere of Authority

• 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.

Position Requirements

• 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.

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):

East Coast USA - Requisition Number: R-098180

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

 

 

Required Skills:

 

 

Preferred Skills:

  

 

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 PLN/y– 262.200 PLN/y

 

 

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.