Regulatory Affairs Manager

Reporting to the Associate Director, Regulatory Affairs, you will be a key member of the team which is responsible for providing strategic and operational regulatory support to project management on new divestment projects, technical transfer, CMOs, quality assurance and commercial departments.

Our Regulatory Affairs Department has an ethos of continuous improvement, refining systems and creating efficiencies. This, along with the rapid growth of the business, leads to a varied and dynamic working environment.

Main responsibilities duties:

• Provides strategic and operational regulatory support to project management on new divestment projects, technical transfer, CMOs, quality assurance and commercial departments
• Leads the preparation of core dossiers and submissions for global roll out
• Authors, reviews and approves M3 dossier sections as necessary, justification documents and Product Information
• In collaboration with global partners, consultancies and distributors, outlines global regulatory intelligence and form a global regulatory strategy
• In collaboration with senior management and project strategy teams, develops and reviews global cross functional regulatory strategies
• Ensure diligent reporting and progress updates on regulatory workload at weekly/bi-weekly internal regulatory meetings
• Negotiates and makes agreements on behalf of the department
• Interprets applicable regulations and guidelines for project team use. Keeps project team abreast of regulatory decisions, evolving regulatory requirements, risks and mitigation plans
• Serves as a primary contact to the local health authority (HA(s), local consultancies/ distributors and internal stakeholders, to ensure timely and accurate submissions
• Facilitates communication between the HA(s) and the project team. Attends and generally leads agency meetings, if required
• Coordinates and solicits components of the submission from various functional areas, distributors and CMOs
• Proactively identifies project issues to the project team and supports mitigation plans
• Attends cross functional meetings, vendor meetings and kick-off meetings as required
• Mentors and/or manages other Regulatory Managers, Regulatory Associates and other junior level or administrative Regulatory staff
• Maintains a high level of professional expertise through familiarity with scientific literature and participation in training courses
• Other responsibilities may include interviewing, hiring, and training employees; planning, assigning, and overseeing regulatory submissions

About you:

Candidates with at least 5 years of regulatory generalist experience within a pharmaceutical company, CRO, CMO, or similar organisation, are likely to have the skills required to be successful in this role. We are also looking for:

• Bachelor s degree in science/health discipline
• Great IT skills including MS Word, Excel, Project, PowerPoint, and Outlook
• Expertise in regulatory submission structure and content (e.g., MAA, NDA)
• Expertise in artwork requirements and review in line with regulations
• Strong knowledge of EU regulatory framework and guidelines
• Experience in compliance and maintaining product life cycle databases and RIMs systems
• Ability to effectively communicate with regulatory authorities
• Ability to independently present complex regulatory strategies with internal stakeholders and partners
• Awareness of emerging markets submission rollouts
• Expertise in writing scientific and technical documents, and strong attention to detail with proofreading materials
• Excellent time management skills with demonstrated ability to juggle multiple competing tasks and demands
• Strong organisational skills to establish priorities including scheduling and meeting deadlines
• Ability to work successfully within cross-functional teams
• Excellent professional communication skills, both written and verbal
• Fluent English language (written and verbal) is required, and another language, especially Italian or French, is desirable

What we offer:

We offer a competitive salary plus bonus and rewards package including holiday, health wellbeing program, employee recognition awards, social events, pension scheme and hybrid working.