Regulatory Affairs Professional, CMC Certificates and Samples - Business Support

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

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Raritan, 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 https://www.jnj.com/innovative-medicine

Johnson & Johnson Innovative Medicine R&D is recruiting for a Regulatory Affairs (RA) Professional, CMC (Chemistry, Manufacturing and Controls) Certificates and Samples - Business Support.  This position is a hybrid role and will be located in Raritan, NJ. 

The RA Professional, CMC Certificates and Samples - Business Support will contribute to the development of global CMC regulatory strategies with reference to Certificate and Sample requirements in collaboration with other CMC RA personnel.

Principal Responsibilities:

• Handle Certificate and Sample registration activities for diverse portfolio of global drug products working with other functions across sites and departments.  This will include managing country specific requirements such as Certificates of Pharmaceutical Product, Good Manufacturing Practices (GMPs), manufacturing license and other documentation to support first submissions, post approval changes, renewals and affiliate or health authority requests.

• Request certificates from Health Agencies (HAs), manufacturing sites and other affiliate offices and ensure documents are correct and available in a timely manner.

• Coordinate notarization and legalization of documents (in many cases working with government agencies).

• Organize and dispatch documentation to global affiliates against strict timelines as part of the approval process for global submissions.

• Organize, request and track orders for registration samples, working with regional and local regulatory affiliates and Global Supply Chain personnel. 

• Participate in cross-functional team meetings, work within a team environment on assigned projects.

• Assist with improvement projects within the department.

Qualifications:

• A minimum of a Bachelor’s degree in Biological, Pharmaceutical, Chemical or Engineering Sciences is required.

• A minimum of 2years overall professional experience is required.

• Experience working in the pharmaceutical, medical device, and/or consumer industries is preferred.

• General knowledge of the regulatory environment, guidelines and practices globally is preferred.

• Knowledge of Regulatory Affairs Chemistry, Manufacturing and Controls (CMC) is preferred.

• Must have excellent verbal and written communication skills.

• Must have strong organizational skills and attention to detail.

• The ability to understand customer expectations and quality of deliverables and deadlines is required.

• The ability to manage multiple tasks/projects/priorities and complex software systems simultaneously is required.

• The ability to work effectively in a matrix environment and collaborate with cross-functional teams and local affiliates globally is required.

The anticipated base pay range for this position in all other U.S. locations is $74,000 to $119,600. 

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/ pe