Senior Scientist, Product Lead CMC Regulatory Affairs

Johnson & Johnson Innovative Medicine•Horsham, PA

2d•$109,000 - $174,800

About The Position

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. We are searching for the best talent for our Senior Scientist, Product Lead CMC Regulatory Affairs position to be in Titusville, NJ; Raritan, NJ or Horsham, PA. Purpose: The Senior Scientist, Product Lead CMC Regulatory Affairs is a leading expert individual contributor and works independently to own major portions of complex regulatory submissions and conveying information to clinical development, commercial, and medical affairs teams on regulatory aspects in a scientific/technical field of expertise regarding clinical study design, labeling, and submission.

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 is required.
Demonstrated ability to communicate regulatory requirements is required.
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 and 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, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.

Nice To Haves

An MS, Ph.D., or Pharm. D. degree preferred.
Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry is preferred.
Prior drug development, analytical development, or manufacturing experience preferred.
Strong attention to detail with high-level verbal and written communication skills preferred.
Communicates cross-functionally and cross-company. Presents and defends CMC management-approved regulatory strategy and opinion to project teams preferred.
Demonstrates model behavior that understands what the priorities are and encourages others to drive for results preferred.
Experience interacting with Health Authorities under supervision of a senior member of the CMC RA staff preferred.
Working knowledge of global HA laws, regulations and guidances preferred.

Responsibilities

Contributing 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.
Supporting global regulatory filings for development compounds and marketed products in collaboration with other CMC RA senior personnel.
Preparing regulatory dossiers for submission to Health Authorities under supervision.
Coordinating, compiling, and managing CMC country specific documents required as part of the approval process for global submissions.
Assisting in developing and preparing CMC Health Authority responses as needed according to the proposed strategy.
May participate in selected initiatives within CMC RA / GRA.
Driving a culture of continuous improvement to ensure compliance with Johnson and Johnson standards, regulatory requirements and expectations.
Communicates critical issues to Management.

Benefits

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)).
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