Drug Safety Associate in Westborough, MA

Reporting to the Associate Director, Global Regulatory CMC, this position will provide Regulatory CMC support for the IRiS to SHARE data remediation and any follow-on submissions that are required.

 
Independently provides project team representation while working closely with Manufacturing, Quality, Technical Support/service groups and Site Senior management to compile the required information in accordance with established timelines;


Monitors and tracks information, assuring accurate communication of the current status of post-approval change control assessments and submissions;
 

Coordinates and prepares regulatory document packages to support post-market changes.

Provides project team representation, consults on regulatory project needs and is responsible for developing required regulatory documentation/submissions.  Provides direction in managing information from/to other departments.  


Reviews technical documentation (Project Plans, Change Control, Deviations, CAPA, Batch Records);

Rangam Consultants is a minority, women-owned, disability workforce solutions global organization. Specialized in attracting and retaining talents globally for a rewarding career in IT, Engineering, Scientific, Clinical, Healthcare, Administrative, Finance, Business Management, and many more, while integrating veterans and individuals with disabilities into the workforce. Indeed, we connect career aspirants to relevant job opportunities, be it jobs in USA, UK, India, or Ireland. Also remote jobs, work-from-home jobs, or contract jobs in different verticals and industries.
Rangam strives to put job seekers first, giving them free access to search for jobs, post resumes, and research companies.Every day, we connect millions of people to new opportunities.