Senior Director, Regulatory Affairs, Immunology
Welcome to Johnson & Johnson, a global leader in the healthcare industry with a focus on improving the lives of patients around the world. We are currently seeking a highly experienced and driven Senior Director, Regulatory Affairs to join our Immunology division. In this role, you will have the opportunity to lead and develop a team of regulatory professionals, while ensuring compliance with all regulatory requirements in the development and commercialization of our immunology products. We are looking for an individual with a strong background in regulatory affairs, specifically in the immunology space, who is able to effectively navigate complex regulatory environments and drive successful outcomes. If you have a passion for making a difference in the lives of patients and possess the necessary qualifications and skills, we invite you to apply for this exciting opportunity at Johnson & Johnson.
- Lead and develop a team of regulatory professionals in the Immunology division.
- Ensure compliance with all regulatory requirements in the development and commercialization of immunology products.
- Establish and maintain relationships with key regulatory authorities to facilitate successful outcomes.
- Provide strategic guidance and expertise on regulatory affairs to cross-functional teams.
- Develop and implement regulatory strategies for new product development and current product maintenance.
- Stay up-to-date on changes in regulatory guidelines and communicate their impact on the company's products and processes.
- Collaborate with internal and external stakeholders to ensure timely and accurate submission of regulatory documents.
- Conduct risk assessments and develop risk mitigation plans to support product development and commercialization.
- Serve as the primary point of contact for regulatory agencies during inspections and audits.
- Monitor and track regulatory submissions and approvals, ensuring compliance with timelines and regulations.
- Develop and maintain Standard Operating Procedures (SOPs) to ensure consistency and efficiency in regulatory processes.
- Act as a subject matter expert on regulatory affairs, providing guidance and training to team members and other departments within the company.
- Continuously evaluate and improve processes to ensure compliance and efficiency.
- Represent the company in industry conferences and meetings related to regulatory affairs.
- Uphold the company's commitment to improving the lives of patients through ethical and compliant business practices.
Advanced Degree In Life Sciences: A Senior Director, Regulatory Affairs, Immunology At Johnson & Johnson Should Possess An Advanced Degree In A Relevant Field Such As Immunology, Pharmacology, Or Biochemistry.
Extensive Regulatory Experience: Candidates Should Have At Least 10-12 Years Of Experience In Regulatory Affairs, Preferably In The Pharmaceutical Or Biotech Industry. They Should Have A Deep Understanding Of Global Regulatory Requirements And Experience With Regulatory Submissions And Approvals.
Strong Leadership Skills: As A Senior Director, This Role Requires Strong Leadership And Management Skills To Lead A Team And Collaborate With Cross-Functional Teams. Candidates Should Have A Proven Track Record Of Successfully Managing And Developing A Team To Achieve Regulatory Goals.
In-Depth Knowledge Of Immunology: Since This Role Specifically Focuses On Immunology, Candidates Should Have A Strong Understanding Of The Science And Regulatory Landscape In This Therapeutic Area. This Includes Knowledge Of Relevant Guidelines, Regulations, And Industry Trends.
Excellent Communication And Interpersonal Skills: Effective Communication And Collaboration Are Essential For A Senior Director In Regulatory Affairs. Candidates Should Have Excellent Written And Verbal Communication Skills, As Well As The Ability To Build Relationships And Influence Stakeholders At All Levels.
Quality Assurance
Change Management
Global regulations
Team Leadership
Compliance Management
Risk assessment
Clinical development
Cross-Functional Collaboration
Product Registration
Regulatory Strategy
Labeling Expertise
Communication
Leadership
Time management
Interpersonal Skills
flexibility
Attention to detail
Teamwork
Active Listening
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Senior Director, Regulatory Affairs, Immunology in Zürich, Switzerland is between CHF 170,000 and CHF 250,000 per year. However, the exact salary may vary depending on the specific company, years of experience, and other factors. It is always best to research the specific company and their salary range for this position.
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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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