Regulatory Affairs Manager (Medical Device) at Short Hills

 

Overview

 

Regulatory Affairs Manager will report to Director of Regulatory Affairs and will manage a project and/or team of Regulatory Affairs Professionals.

 

Duties Include:

•  Preparing and compiling components for regulatory applications

•  Directing others in the preparation of high quality, detailed regulatory documents.

•  Advising on regulatory strategy and executing specific regulatory projects

•  Interacting with regulatory authorities on specific project / product issues as required

•  And depending upon level of experience, may also be responsible for:

o  Managing all parts of a regulatory project including overall strategy, resource, costs, time and clients. Choose the method and processes of work to achieve overall objectives. Ensure that project work proceeds according to agreed deadlines and maintaining status records

o  Assuming responsibility for a functional area or have a unique contribution to a department

o  Working with the commercial team on proposal preparation and visiting client sites with new and existing clients

Your role with us will be exciting and challenging; you may be assigned to a project which is being run from our offices in Maidenhead for 6 months, or alternatively be based at one of our client sites – or a mixture of both! This way of working is not for everyone, but for those who relish the idea of working for different companies on different projects for varying lengths of time then a permanent position at Pharmalink could be for you!

You will undertake a rigorous recruitment process involving a series of interviews and a presentation to ensure that Consulting is the right career choice for you, and that you are right for us and for our clients. Working for Pharmalink on a permanent basis will be the best career move you have ever made – exposure to different clients and projects from large blue-chip companies through to University spin offs, extensive training and development, support from a highly experienced Regulatory team – and we do know how to throw a good social event too!

The success of Pharmalink Consulting depends on its people. Capitalizing on what is unique about individuals and drawing on their different perspectives and experiences will add value to the way we do business.

By accessing, recruiting and developing talent from the widest possible talent pool we can gain an insight into different markets and generate greater creativity in anticipating employee and client needs.

 

We offer our employees a blue-chip benefits package that includes 4 weeks of vacation, matching 401(k), tuition reimbursement, 100% paid health care premiums and MUCH more!

 

 

 

 Requirements

 

•  BS Degree (or higher) in a scientific field, preferably some pharmaceutical or biotech industry experience or training in a scientific area

•  5-10 years’ experience in regulatory affairs, specifically with medical devices

•  An applied understanding of a specific regulatory discipline and the principles, concepts and theories governing Regulatory Affairs

•  Strong written and verbal communication skills in English

•  Ability to work to strict deadlines and under pressure

•  Excellent team player with the ability to work autonomously

•  Ability to travel to Pharmalink and/or client sites on a regular basis

Country: USA, State: New Jersey, City: Short Hills, Company: Pharmalink Consulting.