Janssen Research & Development, LLC. is recruiting for a Senior Associate, Global Regulatory Affairs – CMC. This position can be located in the United States (Malvern/Chesterbrook, PA; Spring House, PA; Horsham, PA; Raritan, NJ; Titusville, NJ; La Jolla, CA; or Fremont, CA), Europe (Leiden, Netherlands; Cork, Ireland; High Wycombe, United Kingdom; or Beerse, Belgium) and Canada (Toronto). Remote work options may be considered on a case-by-case basis and if approved by the Company (within one of the countries list above).

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research and Development, LLC. is part of the Janssen Pharmaceutical Companies.

The Global CMC Regulatory Affairs Senior Associate contributes to the development of global CMC regulatory strategies and dossier plans according to scientific/risk-based principles in collaboration with other CMC RA personnel.

Principal responsibilities:

Regulatory Strategy

• May contribute to the development/implementation of global CMC regulatory strategies and dossier plans for development compounds and marketed products.
• May be a CMC Regulatory Lead on CMC/VST teams.
• Assists in execution or development of contingency plans for issues that affect registration, regulatory compliance, and continued lifecycle management of the product.
• Assists in execution of a CMC strategy that is in alignment with Therapeutic Area, regional strategies, commercial strategy, and Quality Target Product Profile.
• Assists in developing and preparing CMC Health Authority responses as need according to the proposed strategy.

Submissions

• Works with the CMC/VST teams or other CMC RA personnel to develop CMC content and dossier plans.
• Prepares regulatory (CMC) sections of development/project plans and adapts strategy as issues arise to gain rapid approval with reasonable risk.
• Provides input to and assist in the preparation of dossiers for submission to Health Authorities (NDA/BLA /MAA/IND/CTA and post approval variations).
• Leads preparation of country specific required documentations to support global submissions.
• Assists with CMC RA submissions for renewals, annual product submission, and questions from LOC partners/health authorities/other JNJ partners.
• Works with other CMC RA personnel to develop global marketing approval submission plan and timing per the GRT.
• Works with other CMC RA personnel to assure compliance with local regulatory requirements and commitments per the GRT.

Health Authority Interactions

• Assists in preparing responses to HA communications/questions in alignment with global strategy.
• Provides CMC Regulatory support to health authority inspections.

Regulatory Input into Other Functions

• Assists in or conducts regulatory assessments of CMC change controls.

Qualifications

Education:

• BS in engineering, biological, pharmaceutical, or chemical 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.
• MS, Ph.D., or Pharm.D. degree preferred.

Required:

• Prior drug development, analytical development, or manufacturing experience is required.
• Demonstrated ability to communicate regulatory requirements is required.
• Good verbal and written communication skills, good organizational skills and strong attention to detail is required.
• Communicates cross-functionally and cross-company as well and presents and defends CMC management-approved regulatory strategy and opinion to project teams is required.
• Demonstrates model behavior that understands what the priorities are and encourages others to drive for results is required.
• Working knowledge of global HA laws, regulations, and guidances is required.
• An understanding of product development is required.
• Solid understanding of biology, chemistry, and/or engineering relevant to therapeutic area is required.

Other:

• This position will require approximately 5% travel, both International and Domestic.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

The anticipated base pay range for this position in the San Francisco Bay Area, CA is $116,700 to $187,795.

The anticipated base pay range for this position in all other US locations is $102,000 - $163,300.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

• Vacation – up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
• Holiday pay, including Floating Holidays – up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

Additional information can be found through the link below.

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits