
Associate Director, RA Submissions
Welcome to Johnson & Johnson – a global leader in healthcare, with a commitment to improving the lives of people around the world. We are currently seeking an experienced and driven individual for the role of Associate Director, RA Submissions. As a member of our Regulatory Affairs team, you will play a crucial role in ensuring the timely and successful submission of regulatory documents for our products. If you have a strong background in regulatory affairs, excellent project management skills, and a passion for making a difference in the healthcare industry, we want to hear from you. Join us on our mission to advance the health and well-being of individuals and communities everywhere.
- Coordinate and oversee the submission of regulatory documents for Johnson & Johnson products.
- Ensure compliance with all relevant regulations and guidelines in the healthcare industry.
- Communicate with regulatory agencies to obtain necessary approvals and maintain positive relationships.
- Stay updated on changes in regulatory requirements and communicate any potential impact on submissions.
- Collaborate with cross-functional teams to gather necessary information and documents for submissions.
- Develop and maintain project timelines to ensure timely submission of regulatory documents.
- Review and provide feedback on regulatory submissions to ensure accuracy and completeness.
- Manage and mentor a team of regulatory professionals to ensure high-quality submissions.
- Provide guidance and support to product development teams on regulatory requirements and strategies.
- Participate in regulatory strategy meetings and provide input on potential risks and mitigation plans.
- Proactively identify and address any potential issues or delays in the submission process.
- Foster a culture of continuous improvement and innovation within the Regulatory Affairs team.
- Represent Johnson & Johnson in regulatory meetings and conferences.
- Act as a subject matter expert on regulatory affairs within the company.
- Contribute to the overall success and growth of Johnson & Johnson's healthcare mission.
Bachelor's Or Master's Degree In A Scientific Or Related Field, With A Strong Emphasis On Regulatory Affairs.
Minimum Of 5 Years Experience In Regulatory Submissions And Strategy Within The Pharmaceutical Or Medical Device Industry.
In-Depth Knowledge Of Fda And International Regulatory Requirements And Guidelines.
Proven Track Record Of Successfully Leading And Managing Complex Regulatory Submissions Projects.
Excellent Communication And Leadership Skills, With The Ability To Collaborate With Cross-Functional Teams And Effectively Represent The Company To Regulatory Authorities.
Quality Assurance
Project Management
Communication
Leadership
Compliance
Strategy development
FDA regulations
Problem-Solving
Cross-Functional Collaboration
Regulatory Expertise
Global Submissions
Submission Planning
Communication
Emotional Intelligence
Leadership
Time management
Interpersonal Skills
Critical thinking
Teamwork
Active Listening
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Associate Director, RA Submissions in Raritan, NJ, USA is $130,000 - $170,000 per year. However, this can vary depending on factors such as the specific company, years of experience, and education level. It is always best to research the specific job and company in order to get a more accurate salary range.
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Johnson & Johnson is an investment holding company with interests in health care products. It engages in research and development, manufacture and sale of personal care hygienic products, pharmaceuticals and surgical equipment. The company operates through the following business segments: Consumer, Pharmaceutical and Medical Devices.

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