Senior Manager, RA Submissions at Johnson & Johnson

Mechelen, 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, MedTechIndustries

Requirements

Strong leadership capabilities, with proven experience in managing direct reports, mentoring junior staff, and fostering a collaborative work environment
Proven understanding of regulatory requirements related to Clinical Trial Applications, including ICH-GCP, EMA, and other relevant guidelines
Demonstrated experience leading and managing the preparation, review, and submission of CTAs to regulatory bodies
Exceptional analytical skills to identify potential issues, analyze complex data, and develop effective solutions in a fast-paced regulatory environment
Effective verbal and written communication skills, with the ability to liaise confidently with internal teams and external partners
Bachelor’s Degree or higher in Life Sciences, Pharmacy, Regulatory Affairs, or a related field
Strong organizational skills with the ability to manage multiple submissions and regulatory deadlines simultaneously
Ability to work or lead in a matrix environment

Responsibilities

Lead and oversee a CTA team in planning, preparing, and maintaining regulatory submissions and filings, ensuring accuracy and compliance throughout the process. Provide guidance and support for direct reports to facilitate smooth submission workflows
Manage all HR-related processes for the team, including performance management, development, and fostering a positive work environment. Ensure team members are aligned with organizational goals and standards
Drive the coaching and professional development of team members and colleagues, promoting continuous improvement, skill enhancement, and a high-performance culture
Maintain and promote up-to-date expertise on global and regional regulations, ensuring all submissions meet current guidelines, standards, and best practices
Provide leadership and oversight to the CTA team, ensuring the application of appropriate regulatory submission standards, processes, and policies to ensure compliance with regulatory agencies
Analyze team workload, prioritize assignments, and oversee the tracking of submission activities using relevant systems and tools to ensure timely delivery
Lead the development and alignment of submission operational strategies with overarching regulatory strategies, ensuring coherence and efficiency
Drive continuous improvement by leading the development and enhancement of departmental work practices, processes, and workflows
Actively participate in CTA leadership team meetings, contributing strategic insights and supporting decision-making processes
Ensure open, timely, and effective communication channels with all stakeholders and team members to facilitate smooth project execution and meet deadlines
Foster strong coll

Skills

Regulatory Affairs

CTAs

Clinical Trial Applications

ICH-GCP

EMA

Leadership

Submissions

Regulatory Requirements

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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