Senior Director CMC RA Synthetics – Established Modalities

Description

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

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Senior Director, CMC RA Synthetics – Established Modalities

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):

Spring House or Horsham PA and Raritan or Titusville NJ, USA - Requisition Number: R-044620

Allschwil or Zug, Switzerland - Requisition Number: R-044622

Beerse, Belgium and Leiden, Netherlands - Requisition Number: R-041302

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

We are searching for the best talent for Senior Director, CMC RA Synthetics – Established Modalities role.

Purpose: This Senior Director provides strategic leadership and direction for global CMC regulatory affairs, ensuring the development and execution of innovative regulatory strategies that enable timely approvals and lifecycle management of synthetic pharmaceutical products. By leading a team of senior professionals in a matrix environment, the position fosters a high-performing culture through coaching, career development, and alignment with organizational goals and compliance standards.

As a key member of the CMC RA Senior Leadership Team, the incumbent shapes regulatory approaches, influences health authority interactions, and drives consistency in practices, policies, and systems across regions. It serves as a critical advisor to senior stakeholders on regulatory intelligence, risk management, and evolving global requirements, while building strategic relationships with regulatory bodies to support business objectives and maintain product availability worldwide.

You will be responsible for:

• Leading a team of Directors, Senior Managers, and senior individual contributors in a complex matrix environment, ensuring meaningful career development conversations, regular coaching, and actionable feedback.
• Serving as a key member of the CMC RA Senior Leadership Team to define strategic direction, drive organizational performance, and ensure consistent application of policies, systems, and programs across regions.
• Overseeing the development and execution of global CMC regulatory strategies for synthetic products, championing innovative approaches to accelerate approval cycles and optimize lifecycle submissions.
• Planning and coordinating global regulatory submissions to secure and maintain product approvals, while proactively managing risks and opportunities in alignment with supply chain initiatives and portfolio strategies.
• Leading lifecycle management activities for commercial products, including regulatory approvals for line extensions, manufacturing changes, site transfers, and global market expansions, supported by effective resource planning and operational execution.
• Coordinating and leading Health Authority meetings in partnership with regional and local regulatory leaders to ensure successful outcomes.
• Advising senior leaders in Commercial and Supply Chain functions on broad regulatory matters, including labeling, submission strategies, and clinical study design when required.
• Providing regulatory intelligence and insights on evolving global requirements, emerging pathways, and policy developments to inform cross-functional senior leadership teams.
• Ensuring robust procedures and controls are in place to maintain compliance with internal and external standards, driving quality and efficiency across the global regulatory affairs function.
• Representing CMC Regulatory Affairs in senior governance bodies, cross-functional teams, and regional leadership forums to influence decision-making and strategy.
• Building and sustaining strategic relationships with health authorities, professional organizations, and thought leaders across major markets to advance regulatory objectives.
• Managing operational aspects of the team, including budget oversight, performance management, compliance, and workforce planning to meet current and future business needs.
• Creating a purpose-driven environment by aligning Johnson & Johnson’s Credo with team strategies and enterprise goals.

Qualifications / Requirements:

• BS in biological, pharmaceutical, chemical sciences, or engineering with a minimum of 15+ years of experience inclusive of post graduate education and/or in pharmaceutical or health care industry experience. A MS, Ph.D., or Pharm. D. degree (or equivalent) is preferred.
• Strong people management skills are 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; 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 synthetic products with a proven track record and deep understanding in developing and implementing successful CMC regulatory life cycle strategies.
• Experience leading interactions with Health Authorities.
• Strong knowledge of global HA laws, regulations, guidance, and global regulation submission routes
• 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 and life cycle management.
• Strong analytical, problem-solving, and critical thinking skills.
• Collaborative, able to shape and influence without direct line authority. Skilled at engaging and building relationships with senior business stakeholders required.
• Strong communication to create clear and concise messaging to leadership.
• Detail and solution oriented with ability to work within broad guidelines but challenge status quo.

OTHER:

• Requires proficiency in English (written and verbal) to communicate effectively and professionally.
• May require up to 20% of domestic and international travel.
• Requires the ability, through our flexible work policy, to work on-site a minimum of three days each week, with the option for two remote workdays each week.

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