Senior Director CMC RA Synthetics – Established Modalities at Johnson & Johnson

Beerse, Flanders, Belgium

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, BiotechnologyIndustries

Requirements

Strategic leadership and direction for global CMC regulatory affairs
Ability to lead a team of Directors, Senior Managers, and senior individual contributors in a complex matrix environment
Experience fostering a high-performing culture through coaching, career development, and alignment with organizational goals and compliance standards
Membership in CMC RA Senior Leadership Team, shaping regulatory approaches and influencing health authority interactions
Expertise in regulatory intelligence, risk management, and evolving global requirements
Ability to build strategic relationships with regulatory bodies

Responsibilities

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

Skills

CMC

Regulatory Affairs

Synthetics

Regulatory Science

Pre-Clinical Development

Clinical Development

Johnson & Johnson

Healthcare products in pharmaceuticals and devices.

About Johnson & Johnson

Johnson & Johnson operates in the healthcare sector with three main areas: pharmaceuticals, medical devices, and consumer health products. In the pharmaceuticals segment, the company develops prescription drugs for various medical conditions such as cancer and infectious diseases. The medical devices segment provides products used in surgeries and other medical procedures, while the consumer health segment offers over-the-counter products, including baby care and personal health items. Johnson & Johnson generates revenue through direct sales and partnerships, and it invests significantly in research and development to create new products that meet the needs of consumers and healthcare providers. The company stands out from competitors by emphasizing diversity, equity, and inclusion in its workplace, fostering an environment where employees can share their perspectives. Its goal is to improve patient outcomes and enhance the overall health and well-being of individuals globally.

New Brunswick, New JerseyHeadquarters

1886Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

J&J faces a class action lawsuit in Australia over ineffective cold and flu medications.

Former J&J executives joining other firms could lead to increased competition.

Ongoing legal battles, like the lawsuit against Cigna, pose financial liabilities for J&J.

Differentiation

J&J operates in three segments: pharmaceuticals, medical devices, and consumer health.

The company invests heavily in R&D for innovative medical solutions and products.

J&J is committed to diversity, equity, and inclusion in its workplace culture.

Upsides

J&J's collaboration with Helsinki University Hospital focuses on value-based healthcare models.

The rise of personalized medicine offers J&J opportunities in targeted therapies.

Increased focus on digital health solutions presents expansion opportunities for J&J.

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