Regulatory Affairs Project Coordinator

Regulatory Affairs Project Coordinator

McGinley is working with a globally renowned Pharmaceutical Company in the South-East, who are looking for a Senior Analytical Development Analyst to join their rapidly growing team in the UK. Our client specializes in the development, licensing and marketing of niche generic medicines and proprietary brands in the UK and across Europe.

The Regulatory Affairs Project Coordinator will be working within the Regulatory department to support the regulatory activities (Technology transfer – Contract Research and Manufacturing Services). This is a key role in ensuring that the Regulatory applications are being completed within a timely manner and being the key support in liaising with internal and external clients.

Your main responsibilities will be:

Coordinating tech transfer and new product launches.
Requesting and chasing requested documents from formulators, manufacturers and suppliers.
Ordering of Active pharmaceutical ingredient, impurities, innovator samples and sending to formulators or manufacturers for validation batches.
Organising meetings between various departments and external meetings.
Writing and distributing minutes of meetings and tracking outstanding issues.
Liaising with Contract Manufacturers and Quality Control for completion for allocated projects.
Preparation of documents for Regulatory Variations and Quality modules.
Checking documentation meet NEEs (Non-eCTD electronic submission format) requirement for variation and submission.
Proof reading of artworks.
Providing information on trackers to various departments.
Supporting the department for preparation for inspections.
General Administration work related to the Regulatory activities and managing all external and internal communication activities.Experience

Candidates will need to show evidence of the following:

A minimum of 6 months experience of working in coordinating technology transfer of products and project coordination.
Experience of working within a Regulatory department.
Have an understanding of the Quality Assurance and Quality Control department’s activities.
Strong IT skills (proficient in MS Office: Word, Excel and Outlook).
Extremely organised to deal with a variety of projects and able to prioritise conflicting demands.
High level of accuracy and good attention to detail.
Ability to work under pressure with multiple projects to strict on-going deadlines.
The ability to grasp new concepts quickly and to assimilate data from a wide range of Scientific areas.
Excellent communication skills (oral and written) and interpersonal skills.If you feel this job is well suited for you,, or contact us for further information on this role or similar positions.

McGinley Healthcare & Scientific Ltd. is an equal opportunity employer and employment business, committed to a policy of treating all its employees and job applicants equally.