Principal Scientist, CMC Regulatory Affairs

Johnson & Johnson is recruiting for a Principal Scientist, CMC Regulatory Affairs to be located in Raritan, NJ; Titusville, NJ; Horsham, PA; Malvern, PA or Spring House, PA.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/ .For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.At Johnson & Johnson, we all belong.The Principal Scientist, CMC Regulatory Affairs provides support for the registration activities for a diverse portfolio of biologic drug products. This includes country specific requirements, supporting documentation for renewals, annual reports, variations, and affiliate and health authority questions for both new products and post approval changes.Key Responsibilities• Track country approvals and ensure databases accurately reflect registration status.• Provide regular contact with other J&J affiliates around the world both in the Regulatory Affairs department and manufacturing sites.• Interact with external partners including contract manufacturing sites.• Under the direction of management, support pre- and post-approval drug substances and/or drug products for biologics by preparing regulatory dossiers for submission to health Authorities.• Contribute to the development of global CMC regulatory strategies and content plans, ensures that development strategy meets global regulatory requirements over product lifecycles, and further ensures that CMC regulatory strategy is in alignment with global regulatory strategy, Therapeutic Area portfolio, regional strategies, commercial strategy, and the Target Product Profile.• Actively participate on Global Regulatory Teams to develop global marketing approval submission plans and provide accurate regulatory assessments of CMC changes to teams and execution of regulatory planning and implementation.Education:• A minimum of a Bachelor's degree is required. An advanced degree is preferred.Experience and Skills:Required• 6 years of relevant pharmaceutical industry experience within chemistry pharmacy field or related areas is required.• Experience in the pharmaceutical manufacturing environment is required.• Solid understanding of biology and chemistry is required.• Experience with global Health Authorities regulations and guidances is required.• Ability to effectively communicate regulatory requirements and defend strategies to project teams is required.• Excellent interpersonal, teamwork and verbal/written communication skills are required.• Strong organizational skills and the ability to manage multiple tasks/projects/priorities and complex systems simultaneously is required.• Ability to demonstrate model behavior that understands what the priorities are and encourages others to drive for results will be needed.Preferred:• Working knowledge of regulatory laws and guidance is preferred.• Regulatory CMC experience is preferred.• Experience partnering with Quality Assurance, Analytical, and/or Manufacturing Operations experience is preferred.• Prior experience in drug development, analytical development or pharmaceutical manufacturing is preferred.The anticipated base pay range for this position is $113,000 to $195,500.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 of Work, Personal and Family Time - up to 40 hours per calendar year• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefitsThe 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 08/20/2024. 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.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 .