Regulatory Affairs Specialist

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer

We are looking for a Regulatory Affairs Specialist to support the CSS business and Medicinesensuring that regulatory compliance is maintained in the UK/Ireland based in Wokingham, UK.

You will be responsible for ensuring that the company’s products align with relevant legislation and standards and international practices. You will develop and build clear regulatory strategies for new product licenses, modifications, and license renewals.

Responsibilities:

• Setting and communicating timelines for license variations and renewal approvals and advising scientists and manufacturers on regulatory requirements
• Resolving sophisticated issues as they arise and maintaining quality systems undertaking and leading regulatory inspections
• Reviewing company practices and providing advice on changes to systems. Collaborating closely with, and making presentations to regulatory authorities
• Submitting license applications to authorities to deadlines

• You should have experience and knowledge of MDD/MDR directives, environmental directives etc, and experience in new product registration and life cycle management experience.
• Science degree or degree in pharmaceutical sciences with validated ability in Regulatory Affairs in UK and Ireland.
• Experience in leading regulatory policy activities and/or policy advocacy, Ability to drive, challenge and improve the regulatory environment
• Experience in engaging with health authorities, professional organisations, or trade associations.
• A successful track record demonstrating ability to analyze new regulations or policies and assess the impact on the pharmaceutical business or development programs is required
• Excellent oral and written communication skills are essential for the position

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.