Senior Regulatory Affairs Specialist
Are you passionate about ensuring that healthcare products meet regulatory requirements and are safe for patients? Do you have experience navigating complex regulatory landscapes and providing strategic guidance to cross-functional teams? If so, Johnson & Johnson is seeking a talented and driven Senior Regulatory Affairs Specialist to join our team. As a leader in the healthcare industry, we are committed to bringing innovative and life-changing products to market. In this role, you will play a critical role in driving regulatory compliance and supporting the development and approval of our products. We are looking for someone with a strong background in regulatory affairs, excellent communication and problem-solving skills, and a proven track record of success in a fast-paced environment. Join us in our mission to make a difference in the lives of patients around the world.
- Ensure compliance with all relevant regulations and guidelines for healthcare products.
- Provide strategic guidance to cross-functional teams on regulatory requirements and processes.
- Conduct research and analysis on regulatory landscapes to inform decision-making.
- Prepare and submit regulatory submissions for product approvals and registrations.
- Communicate with regulatory agencies and respond to any inquiries or requests.
- Collaborate with internal teams to develop and execute regulatory strategies.
- Stay up-to-date with changes in regulations and industry standards.
- Review and approve labeling, packaging, and promotional materials for regulatory compliance.
- Develop and maintain relationships with key stakeholders, including regulatory agencies and industry organizations.
- Conduct internal audits to ensure compliance with regulatory standards.
- Provide training and support to internal teams on regulatory processes and requirements.
- Participate in product development meetings to provide regulatory guidance and ensure compliance throughout the development process.
- Monitor and track timelines for regulatory submissions and approvals.
- Identify and mitigate potential regulatory risks.
- Support post-market surveillance activities, including adverse event reporting and product recalls.
- Maintain accurate and organized documentation of all regulatory activities and submissions.
- Mentor and train junior regulatory affairs team members.
- Represent the company in external meetings and industry conferences related to regulatory affairs.
- Continuously improve and streamline regulatory processes to increase efficiency and effectiveness.
- Uphold the company's commitment to ethical and compliant business practices.
Extensive Knowledge Of Regulatory Requirements: The Senior Regulatory Affairs Specialist Should Have A Deep Understanding Of Local, National, And International Regulations Related To The Medical Device And Pharmaceutical Industry. This Includes Knowledge Of Fda And Other Regulatory Bodies’ Guidelines, As Well As Experience With Product Registrations And Submissions.
Strong Communication Skills: As A Senior Member Of The Regulatory Affairs Team, Effective Communication Is Crucial. The Senior Regulatory Affairs Specialist Must Be Able To Clearly Communicate Complex Regulatory Information To Various Stakeholders, Including Internal Teams, Regulatory Agencies, And Third-Party Partners.
Experience With Product Registration And Submissions: Johnson & Johnson Products Are Subject To A Variety Of Regulatory Requirements, And The Senior Regulatory Affairs Specialist Should Have Experience Managing Product Registrations And Submissions. This Includes Compiling And Submitting Necessary Documentation, Responding To Queries From Regulatory Agencies, And Ensuring Compliance With All Applicable Regulations.
Leadership And Project Management Skills: The Senior Regulatory Affairs Specialist Will Be Responsible For Leading Regulatory Projects And Managing A Team Of Regulatory Professionals. This Requires Strong Leadership Skills, As Well As The Ability To Effectively Manage Timelines, Resources, And Budgets To Ensure Timely And Successful Completion Of Projects.
Attention To Detail And Problem-Solving Abilities: The Senior Regulatory Affairs Specialist Must Have A Keen Eye For Detail And The Ability To Identify And Resolve Potential Regulatory Issues. They Should Be Able To Anticipate And Address Potential Roadblocks, And Develop Creative Solutions To Ensure Compliance With Regulatory Requirements.
Risk Management
Quality Assurance
Regulatory compliance
FDA regulations
Medical Devices
Clinical Trials
Regulatory Strategy
Pharmaceutical Industry
Labeling Requirements
Global Submissions
Post-Market Surveillance
Communication
Emotional Intelligence
Leadership
Time management
Interpersonal Skills
creativity
Critical thinking
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Senior Regulatory Affairs Specialist in Irvine, CA, USA is between $90,000 and $120,000 per year. However, this can vary depending on factors such as years of experience, specific industry, and the company's size and financial status. Additionally, bonuses and benefits may also be included in the overall compensation package.
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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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