Manager, CMC Regulatory Affairs 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:
People Leader

All Job Posting Locations:
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 https://www.jnj.com/innovative-medicine

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):
? United States - Requisition Number: R-000939
? Belgium - Requisition Number: R-005193

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 Manager, CMC (Chemistry, Manufacturing and Controls) Regulatory Affairs Certificates and Samples - Business Support. This position is a hybrid role and can be located in Raritan, NJ; Titusville, NJ; or Spring House, PA.

The Manager, CMC RA Certificates and Samples - Business Support will be a people leader with project management responsibilities. This role will have end to end responsibility for the Certificates and Samples processes within CMC Regulatory Affairs.

Principal Responsibilities: ? Request Certificates of Pharmaceutical Product, Good Manufacturing Practice (GMP) and Manufacturing License certificates from Health Authorities and manufacturing sites. Ensure that all certificates are legalized correctly and are submission ready in compliance with global standards. ? Develop, execute and oversee accurate planning for finished product samples. Coordinate with relevant departments to meet regulatory and logistical needs. Collaborate with cross-functional teams to ensure sample availability aligns with global submission plans. ? Lead, mentor and develop a high-performing team. Foster an inclusive and positive work environment where team members feel valued and supported. ? Encourage innovative thinking. Implement strategies for continuous improvement. ? Communicate effectively with team members, peers, and management. Provide project status updates and ensure information flows seamlessly within the team. Communicate critical issues to management. ? Effectively manage resources, including time, budget and personnel. Prioritize tasks and delegate responsibilities appropriately. ? Identify problems and implement effective solutions. Navigate complex situations and make informed decisions. ? Drive a culture of continuous improvement to ensure compliance with Johnson & Johnson standards, regulatory requirements and expectations.

Qualifications: ? A minimum of a Bachelor's degree in Biological, Pharmaceutical, Chemical or Engineering sciences is required. ? A minimum of 5 years of experience in the pharmaceutical or health care industry experience is required. ? Regulatory Affairs experience is required. ? Understanding of regulatory documents and the submissions process is required. ? Experience with planning and executing country specific requirements for regulatory submissions, including Certificates of Pharmaceutical Product (CPP) and the legalization of documents globally, is preferred. ? Experience interacting with Health Authorities, manufacturing sites and affiliate offices is required. ? People management experience is required. ? Project management experience is required. ? Must have excellent verbal and written communication skills. ? Must demonstrate model behavior that understands what the priorities are and encourage others to drive for results. ? The ability to communicate cross-functionally and cross-company, and present and defend CMC management-approved systems strategies and opinions to project teams is required. ? The ability to collaborate with all levels across a matrix organization.

The anticipated base pay range for this position in all other U.S. locations is $115,000 to $197,800.

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

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

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

This job posting is anticipated to close on April 3, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

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.

#LI-Hybrid

The anticipated base pay range for this position is :
The anticipated base pay range for this position in all other U.S. locations is $115,000 to $197,800.

Additional Description for Pay Transparency:
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)). This position is eligible to participate in the Company's long-term incentive program. 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 of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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