Associate Director - Regulatory CMC - Cork

Company: Confidential
Your Application: You have not applied yet
Location: Cork, Irlanda

Job Summary

Jul 23,

Excellent opportunity to join a pharmaceutical company based in as an Associate Director - Regulatory CMC. See below

A Regulatory CMC Associate Director is now required to join a pharmaceutical company in on a contract basis

The Regulatory CMC Associate Director will lead the site Regulatory team to support operations in the facility. The Regulatory CMC Associate Director is responsible for providing Regulatory Chemistry Manufacturing and Controls CMC oversight and will be the primary regulatory CMC for technology transfer activities and will manage interactions with Health Products Regulatory Authority and other regulatory authorities for assigned projects.

The position requires knowledge and experience in biologics and/or pharmaceuticals. The successful candidate must possess technical expertise in the areas of responsibility and demonstrate effective problem solving, strong understanding of regulatory affairs submissions and management skills and the ability to prioritize multiple tasks.

Key Responsibilities:

Working closely with Quality Assurance, Quality Control and
Manufacturing groups to assure the relevant product and regulatory expectations are met.
Act as the primary regulatory CMC with contract manufacturing organizations CMOs based in Europe.
Timely compilation and management of all necessary documentation for regulatory submissions.
Ensure submissions are of high quality; that content and format of regulatory submissions comply with application regulations and guidelines governing the development, licensure, and marketing of drugs and/or biologics.
Provide regulatory CMC support for impact assessment to change control, deviation and inspection management.
Coordinate and track regulatory commitments related to the site.
Lead and/or participate in cross-functional project teams and work effectively with multiple disciplines and personalities. Demonstrate initiative and have the ability to work both independently and collaboratively in a team structure and in a global organization.

Work Day: Full Time
Employment type: Permanent Job
Salary: Negotiable

Minimal experience: No experience

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