Salary To be Discussed
17 days ago
Our Client, a leading Pharmaceuticals Organisation in Essex are looking to hire a Regulatory Affairs Manager to join their fast expanding team.
Main responsibilities & duties as Regulatory Affairs Manager Include:
- 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.