Chemistry Manufacturing Controls Manager

Vertex Inc.•Boston, MA

7d•$103,200 - $154,800•Hybrid

About The Position

This notice is being provided as a result of the filing of an application for permanent alien labor certification for the below job opportunity. Employer: Vertex Pharmaceuticals Incorporated. Job Location: 50 Northern Ave., Boston, Massachusetts 02210. Openings: 1. Job Type: Full Time. Telecommuting permitted up to 40%.

Requirements

Preparation, including writing, of chemistry manufacturing control (CMC) submissions for both investigational and marketed products.
Demonstrated ability to assess post approval change for regulatory impact in global markets.
Experience in supporting regulatory inspections, audits, and inspection readiness activities from a CMC documentation and compliance perspective.
Demonstrated experience utilizing web-based publishing software, including Veeva, to facilitate regulatory submissions.
Sound knowledge of current Good Manufacturing Practice (cGMP) regulations and global regulatory frameworks including Federal Drug Administration (FDA), European Medicines Agency (EMA), and International Council for Harmonization of Technical Requirements for Human Use (ICH) for investigational and marketed products.
Evaluation of development and commercial change controls to identify any GMP-related changes that may impact regulatory applications.

Responsibilities

Review chemistry manufacturing control (CMC) sections of regulatory submissions, as well as the interactions and responses with regulatory agencies.
Contribute to the development of global regulatory CMC strategies for investigational and commercial products.
Work with regulatory colleagues in development of global regulatory CMC strategies and submissions.
Provide regulatory CMC guidance to cross-functional teams and key stakeholders.
Influence regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations.
Participate effectively on cross-functional teams and serve as the primary regulatory CMC contact for assigned products and projects.
Influence the execution of multi-product global regulatory CMC strategies for investigational and marketed products.
Contribute to the preparation and submission of regulatory CMC documentation and interact with Health Authorities for CMC topics.
Provide regulatory support and guidance to various cross-functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into investigational and commercial programs.