Provides leadership in support of the Regeneron portfolio products assigned and platform initiatives. The candidate will be responsible for leading the development and execution of global regulatory strategies for biologic products and combination...
Responsibilities: US Agent for all products, responsible for communication between the FDA and manufacturing sites. Communicate and follow-up status with FDA for any Chemistry, Bioequivalence and Patents issues and correspondences on both pending and...
Our client is seeking an experienced Regulatory Affairs professional to join their team based in North-Central New Jersey. The ideal candidate will have a strong technical background in Chemistry, Manufacturing, and Controls (CMC) regulatory...
Associate Director, Regulatory Affairs – OncologyLocation – Berkshire (3 days office – 2 days remote) Salary – 109,000 – 115,000Permanent position An exciting Associate Director opportunity working for a global pharmaceutical company within...
Job Title: Project Manager (Regulatory Affairs) Job Location: New York, New York (Hybrid- 3 days/ onsite) Job Type: Contract long-term A global investment bank is seeking a Regulatory Project Manager with 10+ years...
Responsible for preparing, reviewing and submitting to the Agency new ANDAs, NDAs, DMFs INDs, Supplements (PAS, CBE-30, CBE) and responses to FDA's deficiencies pertaining to submissions. In addition, Senior Regulatory Affairs Associate is...
Description: BASIC FUNCTION: The Divisional Director, ORS is responsible for the management and direction of the clinical department and functions collaboratively with the Nurse Supervisors and Medical Directors to plan,...
Description: BASIC FUNCTION: The Divisional Director, ORS is responsible for the management and direction of the clinical department and functions collaboratively with the Nurse Supervisors and Medical Directors to plan,...
On behalf of our client, Procom Services is seeking a Director of Quality and Regulatory Affairs. As the Director of Quality and Regulatory Affairs, you will play a crucial role in the success of the organization by ensuring product quality...
This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we...