Regulatory Affairs Manager
Proclinical is currently recruiting for a Regulatory Affairs Manager / Senior Executive for a pharmaceutical company located in Essex, England. Successful candidate will assist in providing regulatory strategic advice and life cycle maintenance for the portfolio, globally. In addition, support with new product development initiatives.
- 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.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Roberto Esposito at (+44) 0203 761 5702 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.