22 days ago
Our Client, a Global Pharmaceuticals Organisation in Essex are looking to hire a Deputy Head of Regulatory Affairs to join their fast expanding team.
The Client's Offices are based in Essex but the role offers 3 days a week remote working.
The Client's regulatory department is responsible for providing regulatory strategic advice and life cycle maintenance for the portfolio, globally as well as support with new product development initiatives.
Main responsibilities & duties as Deputy Head of Regulatory Affairs include:
- Reporting to the Head of Reg Affairs this is a number 2 position within a fast paced, exciting and rapidly growing function
- Management and development of multiple functions and teams
- 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 meeting.
- 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.
- Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and overseeing regulatory submissions.