Regulatory Affairs Specialist - Remote

Regulatory Affairs Specialist - Remote

This role is remote but you must be UK based!

We are looking for 2 candidates!

The Company:

Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

The Project:

Drawing on relevant expertise and information from both internal and external sources, responsible for the preparation and uploading of critical regulatory documentation for submissions to the UK CABs for obtaining UKCA approval for the GB market. Secondary support of regulatory affairs activities as directed.

The Role:

The RA professional at this level should have knowledge related to the regulation of healthcare products, including regulatory frameworks, requirements, legislation and processes.  The specialist should possess skills such as basic project management, communications, interpersonal skills and the ability to understand scientific and health concepts. 

Under minimal supervision, the individual develops and executes regulatory strategies to support regulatory authorization of products in GB.  The Specialist helps define performance requirements and data needed for regulatory actions in conjunction with cross-functional teams.

Duties and Responsibilities:

• From varying data sources, identify and extract required data to create and/or maintain product records.
• Maintaining data integrity of the product and legal manufacturer information
• Preparing contracts per legal manufacturer with UK CABs
• Preparing submissions to support UKCA approval
• Work cross functional with internal teams to gather data and records
• Assisting with submitting license applications to authorities to strict deadlines
• Updating internal systems in relation to these licences/registrations
• To assist other members of the team with issues as they arise

Professional Experience Required:

• Proven regulatory submission experience
• Proven experience of working with EU NBs
• Strong database experience
• High degree of initiative
• Team player fosters the strength of a network
• Well organized, sense for detail
• Experienced in working remotely and in a virtual team
• Fluent in English

Education Requirements: 

• Successful graduation in a Life Science degree or equivalent

Other Requirements:

• Strong team player
• Excellent communication and interpersonal skills, ability to influence and motivate
• Proven success at meeting strategic goals and KPIs

In Return:

In return for this role you will receive a very competitive hourly rate. A minimum 12 month contract & an opportunity to work with a Global Leader within the Pharmaceutical sector, Johnson & Johnson. 

Things to remember before applying for this role:

• This role is INSIDE IR35. The pay rate for this role will depend on how you are paid (PAYE or Umbrella options).
• We are looking to process the first round of applications within the next 2 working days.
• We do not accept applications via email.
• You MUST be UK based to apply for this role.

If you are interested in this role please apply now! Make sure you fill out your application in full, you’re personal CV will be used for the recruiter’s reference only, they are not sent to Hiring Managers. Ensure all relevant information is included in your application! 

Thank you very much and we look forward to receiving your application.