Experienced RA Professional, Digital Regulatory Scientist at Johnson & Johnson

Raritan, New Jersey, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, MedTechIndustries

Requirements

Minimum of a Bachelor’s degree in a scientific or equivalent discipline
Minimum of 2 years relevant industry experience
Basic understanding of the drug development process

Responsibilities

Drive continuous improvement of regulatory submission processes, roles, and workflows across global markets
Lead initiatives to realign responsibilities, identify synergies, and optimize end-to-end submission content processes considering regional regulatory requirements
Map and maintain global process documentation to ensure clarity, compliance, and consistency across regions
Identify high-value scopes of work for digitalization, automation, or transfer to other organizational teams, ensuring scalability for global operations
Bridge global business needs with technology solutions to enable digital transformation in content operations
Gather and validate business and user requirements for new tools, automations, and processes across diverse geographies
Partner with IT, Digital Innovation, and regional process leads to design and deploy technology solutions that meet global standards
Collaborate closely with Regulatory Affairs and Digital Innovation teams worldwide to align improvements with broader global strategies
Support prioritization and funding decisions for digital initiatives with consideration of global impact and regional variations
Serve as a liaison between global operations, regulatory functions, and technology teams to ensure seamless integration
Track and report value realization from digital transformation initiatives across all regions
Ensure high standards of delivery, compliance, and continuous improvement globally, adhering to international regulatory frameworks

Skills

Key technologies and capabilities for this role

Regulatory AffairsDigital RegulatoryRegulatory SubmissionsDigital InnovationHealthcare InnovationMedTechInnovative Medicine

Questions & Answers

Common questions about this position

Is this a remote position?

This is a remote role based in the United States, with specific cities listed for reference only. Remote work options may be considered on a case-by-case basis and if approved by the Company.

What are the main responsibilities of the Digital Regulatory Scientist?

The role involves driving continuous improvement of regulatory submission processes, leading process optimization across global markets, and identifying opportunities for digitalization and automation. You will bridge business needs with technology solutions, gather requirements for new tools, and partner with IT and Digital Innovation teams.

What is the salary for this position?

This information is not specified in the job description.

What is the company culture like at Johnson & Johnson?

Johnson & Johnson emphasizes healthcare innovation to prevent, treat, and cure complex diseases, with a patient-inspired approach in Innovative Medicine. They focus on developing smarter treatments and profoundly impacting health for humanity through collaborative teams.

What makes a strong candidate for this role?

Strong candidates will have experience in regulatory affairs, particularly in digital transformation, process optimization, and global regulatory operations. Expertise in bridging business needs with technology solutions and partnering with IT teams is key, even though an internal candidate is pre-identified, all applications are considered.

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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