Director, CMC Regulatory Affairs Biologics New Modalities

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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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-021142

• Netherlands, Belgium - Requisition Number: R-029217

• Switzerland - Requisition Number: R-029225

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 Director, CMC (Chemistry, Manufacturing and Controls) Regulatory Affairs Biologics New Modalities. This position is a hybrid role and can be located in Leiden, Netherlands or Beerse, Belgium.

The Director, CMC Regulatory Affairs Biologics New Modalities will lead a team of CMC regulatory professionals and will be responsible for development, implementation, and maintenance of global CMC regulatory strategies for innovative biologics, including Cell and Gene Therapy (CGT) products over their lifecycle.

Principal Responsibilities:

• Collaborate closely with senior leadership to shape strategic direction in critical areas, fostering a high-performance organization with consistent application of practices, policies, systems and programs.

• Lead planning, organization, and resource allocation within CMC Regulatory Affairs, focusing on new modalities, such as CGT. Partner with business support teams to drive the execution of key projects and workstreams.

• Lead initiatives within CMC Regulatory Affairs (RA)/Global Regulatory Affairs (GRA) for the Biologics New Modalities group.

• Supervise and provide leadership and oversight for the CMC RA teams that develop and execute global CMC regulatory strategy for one or multiple products.

• Identify, prioritize and drive projects and workstreams. Ensure that appropriate objectives and metrics are established, monitored and met, including removing barriers.

• Participate in and conduct due diligence/licensing evaluations as needed.

• Train, coach and develop team members.

• Drive a culture of continuous improvement to ensure compliance with Johnson & Johnson standards, regulatory requirements and expectations. Communicate critical issues to Senior Management.

• Represent CMC RA on Cross Functional Governance Committees.

• Serve as a Single Point of Contact (SPOC)/Subject Matter Expert (SME) on internal and external teams to proactively influence policy and practice on specific areas of CMC regulatory expertise related to innovative biologics.

• Create engagement and a culture of collaboration flexibility, and competitiveness by increasing business and scientific acumen, industry knowledge and skills.

• Enable a culture of performance driving a more flexible organization using levels as process improvement and innovation supported by the business support group.

Qualifications:

• A minimum of a Bachelor’s degree is required, preferably in Cell and Molecular Biology, Pharmaceutical Sciences, Chemistry or Bioengineering. An advanced degree (Master’s, Ph.D., Pharm. D.) is preferred.

• A minimum of 12 years of experience, inclusive of post graduate education, in the pharmaceutical, healthcare or related industry is required.

• Solid understanding of biology, chemistry and/or bioengineering relevant to pharmaceutical industry is required.

• Proven track record and/or strong understanding in developing and implementing successful CMC regulatory lifecycle strategies is required.

• Expertise in product development and how it is applied to global regulatory strategies is required.

• Experience leading health authority interactions is required.

• Strong knowledge of global regulatory laws, regulations, guidance and submission routes pertaining to drugs from early development to commercial maturity is required.

• Good understanding of competitors in the area and their current activities in early/late development within Biologics New Modalities space, including Cell and Gene Therapy, is required.

• People management experience is preferred.

• Experience in leading a diverse community of professionals in a global and matrix environment is required.

• Must have excellent verbal and written communication skills.

• Must be a seasoned leader, decision maker and constructive challenger.

• Must demonstrate model behavior that understands what the priorities are and encourages others to drive for results.

• The ability to communicate cross-functionally and cross-company, present and defend CMC management-approved regulatory strategy to project teams and recognize and account for global regulatory impact is required.

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