REGULATORY AFFAIRS MANAGER
Closing date for applications: 4 January 2021
MAC Clinical Research manages clinical trials for the pharmaceutical industry and we are seeking to appoint a Regulatory Affairs Manager who is keen to learn and make a positive impact in a world-leading Clinical Development Organisation. Individual flair and enthusiasm will help you to develop quickly into the role and build a long-term career at MAC. This position would be a remote working role and could also be based at any of our office locations.
The focus of this role is to develop, lead and manage the Regulatory Affairs department and provide expert Regulatory Affairs support to MAC Clinical Research and its customers. You will develop best working practices and Standard Operating Procedures to deliver the portfolio of projects within the Regulatory Affairs Department.
Developing regulatory strategy for incoming opportunities and Proposals
Provide leadership for the Regulatory Affairs aspects of projects within the Regulatory Affairs department.
Drive and develop the processes to support all activities within the Regulatory Affairs department.
Ensure RA deliverables are achieved on time and to high quality.
Coordinate the RA activities and resources for the RA department and
Serve as a resource for allocated projects and its deliverables.
Ensure that all RA activities are performed in line with relevant SOP’s and in accordance with GCP and appropriate regulatory guidelines.
Ensure customer satisfaction.
Educated to Degree level (or equivalent) in an area relevant to the role.
Considerable demonstrable experience in Regulatory Affairs within a CRO or Sponsor company and in-depth working knowledge of effective practices.
5 years+ experience in a senior Regulatory Affairs role within the Pharmaceutical or CRO industries
Expert knowledge of the regulatory framework that surrounds drug development and the clinical trial process
Ability to lead by example on process development, departmental and project objectives, and overall business strategy and initiatives.
Able to proactively identify risks and issues and be able to devise mitigation and contingency plans and solve problems as they arise.
Knowledge of drug development process including the relationship between the CRO industry and Pharmaceutical companies.
Knowledge of clinical trial process; including the interaction between the Regulatory Affairs team with the wider project team and clinical operations
Competitive salary in keeping with pharmaceutical industry standards and will reflect experience
Free onsite parking
25 days annual leave (increasing in increments to 30 days after 6 years long service)
Your birthday off work
Regular hours (including Christmas Day, Boxing Day and New Years Day off)
MAC Clinical Research invites applications from highly motivated candidates, with a desire to achieve their full potential. You will be working with an organisation that sees you as an investment and is keen for you to achieve your career aspirations.
Please note that if we receive a high volume of applications this date may be brought forwards.
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