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Description:

Johnson & Johnson is recruiting for a Senior Director, CMC Regulatory Affairs Biologics – New Modalities, located in either Horsham, PA; Titusville, NJ; Raritan, NJ; or Beerse, Belgium.

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/.

Reporting to the VP CMC Regulatory Affairs (RA) Biologics, the Senior Director, CMC RA Biologics -- New Modalities oversees the development and execution of the global CMC regulatory strategy for biological products including Cell & Gene Therapies, CAR-T, bi- and tri-specific antibodies, and radiopharmaceuticals.

Key Responsibilities:

• Directs Directors, Senior Managers, and senior individual contributors in a matrix environment. Accountable for meaningful career development conversations and regular coaching and feedback.
• Drives innovative regulatory approaches using existing guidance and shapes new approaches to assure fast and efficient approval cycles.
• Plans and coordinates the cross-departmental preparation of regulatory submissions to obtain and maintain approval for pharmaceutical products and/or manufacturing and controls, considering portfolio strategies, and conducting a proactive management of risk and opportunities.
• Contributes to obtaining regulatory approvals and market access by overseeing and leading resource planning needed to ensure an effective execution of regulatory strategies and operational plans, including interactions with health authorities.
• Coordinates and leads Health Authority meetings in collaboration with regional and local regulatory leaders.
• Provides advice to clinical development, commercial, and medical affairs senior leaders/teams on broad regulatory aspects of clinical study design, labeling, and submission.
• Provides regulatory intelligence and insights on the evolving regulatory environment/climate and developments in regulatory strategies/pathways and on current regulatory processes, policies, and product/program specific regulatory aspects to cross-department global/regional Senior Leadership Teams (e.g., GRA, R&D and/or Commercial SLTs).
• Ensures appropriate procedures and controls are in place to ensure compliance to internal and external requirements, and to achieve quality and efficiency across and beyond the global regulatory affairs function.
• Represents CMC regulatory affairs in major disease area/program/sub-function/regional area in senior internal management and governance bodies (Senior Leadership Teams, Committees, Review Boards, etc.).
• Builds and maintains strategic relationships and associations with key regulatory health authorities, professional bodies, and thought leaders across major markets.
• Responsible for managing operational aspects of their teams (e.g., budget, performance, and compliance), as well as implementing workforce and succession plans to meet business needs.
• Proactively creates a purpose driven environment by aligning Johnson & Johnson’s Credo and Leadership Imperatives with the strategies and goals of the team and enterprise.

Qualifications:

Qualifications

Education:

• BS in biological, pharmaceutical, chemical sciences, or engineering is required.
• MS, Ph.D., or Pharm. D. degree (or equivalent) is preferred.

Experience and Skills:

• A minimum of 15 years of experience, inclusive of post graduate education and/or in the pharmaceutical or health care industry.
• Strong people management skills required. Minimum of 5 years demonstrated leadership and people development skills within a regulatory function preferred.
• High-level verbal and written communication skills. Strong attention to detail.
• Communicates cross-functionally and cross-company as well and presents and defends CMC management-approved regulatory strategy and opinion to project teams.
• Demonstrates model behavior that understands what the priorities are and encourages others to drive for results.
• Demonstrates innovative approaches to drive CMC regulatory strategies for biological products.
• Experience leading interactions with Health Authorities.
• Strong knowledge of global HA laws, regulations, guidance, and global regulation submission routes available for new study drugs.
• Ability to successfully work in ambiguity and shape new guidance on a global level.
• Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry.
• Experience developing regulatory strategies and an understanding of product development.

The anticipated base pay range for this position is $187,000 to $322,000. 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."

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. https://www.careers.jnj.com/employee-benefits

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.