Role Purpose

Management of processes to ensure compliance with regulatory requirements and an inspection ready culture

Key Role Activities

• Provide Regulatory support for a portfolio of promoted and non-promoted products 
• Prepares and submits regulatory documentation with support from RSMO as required. 
• Monitors deadlines for different projects to ensure they are met or escalated to a Senior Regulatory manager and/or Head of RA. 
• Responsible for the content of the local labelling documents released to prescribers and patients. 
• Prepares and distributes local labelling documents within stipulated timelines following receipt of relevant approvals from RRR. 
• Prepares for and manages local procedures following the EMEA Regulatory Affairs strategic plan, assuring timely execution and compliance 
• Partner with allocated CVT to provide RA expertise and support Implements of RiskManagement Plans and when required co-ordinates cross functional team to implement/update Risk Management Educational Material.
• Complete above activities to ensure compliance with all regulatory requirements 
• Develops and maintain in depth knowledge of regulations/legislation. 
• Supports EMEA with collection of RA competitive intelligence as required. Internal contacts 
• Support other departments based on their needs (e.g. Supply Chain, Quality, Medical, and Commercial) by providing documentation and information in response to requests.

Qualifications

• University Degree in Pharmacy, Biology, Chemistry or related Life Science
• Registration with official governing bodies e.g. General Medical Council, Royal Society of Pharmacists Member of The Organisation for Professionals in Regulatory Affairs

Occasionally flexible work hours

Additional information about the process

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services