Regulatory Affairs Jobs in Indiana

Strong knowledge of current drug development regulations and guidelines including ICH, FDA and EMA guidelines; NDA experience is required.

Minimum of 10 years of experience across Regulatory Affairs or another transferrable function in biotech/pharma

Both clinical and CMC experience is desired

Bachelor’s degree is required; advanced degree is preferred.

A passion for the psychedelic and mental health industry

Director/Senior Director of Regulatory Affairs

Serves system administrator for the client's US Regulatory electronic document management system

Helps to author, develop and/or collaborate on SOPs and Work Instructions for the Publishing and Electronic Document Management System

This person will serve as the primary publisher of US Regulatory submissions (Drug and Device)

Publishes US Regulatory Submissions to the Food and Drug Administration: NDAs, INDs, ANDAs, Amendments, Supplements, Annual Reports, PADERS, etc. on time

Works on all aspects of document workflows associated with submission authoring, review, compilation and publishing for various submission types

Regulatory Affairs Ops Specialist I

Track and manage documentation for the Regulatory Project Plans including agency consultation,

Support variety registration when applicable and verify data needs and generation. Manage filing

Support Regulatory Intelligence activities and tracking evolution of data requirements and

Monitor Regulatory competitor activities and access to information where available. Manage the

Solid experience in biological sciences, preferably agricultural sciences, or related disciplines;

3-5 years of work experience in agricultural or microbial biotechnology

Bachelor’s degree with a strong academic record. Relevant internship or professional (e.g., public policy, economics, finance) experience.

We are proud to offer the following featured benefits

Excellent communication, both written and oral, and analytical skills.

FSA and Commuter benefit programs

Working with members of the ISS Regulatory Affairs team and internal stakeholders to identify policy risks and opportunities.

Tracking, synthesizing, and summarizing legislative and regulatory developments and proceedings, including for non-technical audiences.