Regulatory Manager

  •  

Boston, MA

Industry: Pharmaceuticals & Biotech

  •  

Not Specified years

Posted 64 days ago

  by    Sam Murphy

This job is no longer available.

Your responsibilities:

Promotional Material Review Process Owner:

To manage the Promotional Material process and perform related audits thereof.

To act as key contact for the Zinc database

To develop, mentor and run training sessions on the promotional material review process.

Promotional Material Reviewer:

Undertake the review of promotional materials in the capacity of Regulatory Affairs reviewer in compliance with the ABPI code and EU regulation.

Submission Management:

Act as a backup and appropriate submission support to Regulatory Affairs Associates including?support regulatory submissions, approvals and reconciliation of Regulatory changes through to implementation. Status of dossier compliance to be assured at all times.

Liaising with Merck Group Companies, associate companies, licensors and business partners to obtain the necessary information to compile successful submissions to the Regulatory Authorities. Supporting the Regulatory Affairs team for all aspects of artwork requests and approvals.

Who you are:

Fully conversant with Zinc software or similar application is strongly desirable. Ability to lead the Medical, Legal and Regulatory review process including training new starters, embedding the process across the business, identifying training needs, identifying process improvement and regularly auditing the process.

A Degree or Doctorate in health-related science, life science, Pharmacy.

Previous experience in promotional material review desirable and in Regulatory Affairs is preferred but it is not essential.

If you do not have experience in Regulatory Affairs you will have an interest to develop in this area and undertake regulatory tasks and act as a back-up for the Regulatory team.

Excellent organisational, verbal, written and communication skills and the ability to work under pressure to tight deadlines.?Good knowledge of clinical data and clinical studies to be able to understand relevance of medical publication.

What we offer:

Your possibilities to develop in our growing company are just as manifold as our product portfolio. We?offer a modern and international working environment to unleash your innovative potential in diverse teams, and take responsibility for our employees, products, the environment and society.

Salary

$168K - $192K