Regulatory Affairs Specialist / RA Project Manager

Long term: Responsible for maintaining regulatory compliance of Norgine’s marketing authorisations in all markets.

Short term: To provide Regulatory expertise during a compliance and remediation Module 3 CMC exercise (LINKS) to ensure that Module 3 dossier contents for registered products are aligned with manufacturing site activities.

This will include but is not be restricted to:

• Review and management of regulatory compliance strategies in liaison with relevant business partners and third parties
• Assistance with dossier retrieval, review (gap analysis) and remediation activities
• Regulatory assessment of manufacturing and supply change control proposals
• Liaison with relevant departments to ensure effective execution of regulatory strategies within company approved processes and procedures
• The project will be managed in accordance with approved policies and processes and must be delivered to agreed timelines.

DUTIES & RESPONSIBILITIES:

• Support regulatory colleagues in the retrieval of registered information
• Assist Technical Development in gap analysis of regulatory details versus manufacturing documents and record findings as required by project LINKS
• Develop and implement regulatory submission strategies to remediate any gaps identified through the gap analysis
• Liaise with Technical Development, M&S and others to obtain data and author submission ready documents, where necessary, in support of the submission strategies
• Prepare regulatory variation applications to support remediation activities
• Ensure correct regulatory management and assessment of change controls. Provide regulatory support to or trigger change control, where necessary
• Support any regulatory questions raised on authority assessment of the remediation variations
• Ensure all applicable regulatory information is stored securely and that databases and trackers are maintained
• To work in accordance with company policies and procedures
• Communicate effectively to all stakeholders to ensure timely implementation of cmc changes and regulatory commitments are met

INDIVIDUAL REQUIREMENTS:

• A scientific degree is essential
• A working knowledge of CMC in a regulatory and quality environment is essential, together with previous Module 3 experience
• A working knowledge of regulatory variation applications in Europe markets for products registered via the MRP/DCP and national routes.
• Good knowledge of EU GMP guidelines for the manufacture of pharmaceutical products
• Previous experience in change control processes and regulatory compliance related activities is desirable
• Demonstrates an ability to analyse and critique data. Able to make data driven recommendations/decisions and take appropriate action based on the facts
• Proven ability to follow up and close out actions
• Excellent verbal and written communication skills. Languages required : English ; other languages desirable : French
• Ability to present effectively to groups
• Influencing and negotiating skills. Ability to influence and challenge
• Works cooperatively within a team. Excellent teamwork within and across Technical Development, M&S and all other Business Units
• Able to work effectively without supervision
• Ability to work and lead successfully in a matrix organisation. Close collaboration with key Norgine personnel across all Business Units and within Technical Development and M&S where necessary
• Develop and maintain up to date knowledge with regard to guidelines