Regulatory Affairs Professional

Job Title: Regulatory Affairs Professional (CMC, Strategist, Operations, AdPromo, and Labeling)
Location: New Jersey
Job Type: Full-time
About Us
Our Client is a startup company in Pharmaceutical industry seeking Regulatory Affairs Professional that would be interested in a small company where the opportunity to wear several hats
Job Overview
As a Regulatory Affairs Professional, you will play a crucial role in ensuring regulatory compliance across all aspects of our operations. This multifaceted position requires expertise in Chemistry, Manufacturing, and Controls (CMC), Regulatory Strategy, Operations, Advertising and Promotion (AdPromo), and Labeling.
Qualifications
Minimum B.S. degree in life/health/technical sciences required
Postgraduate degree in Regulatory Affairs considered a plus
Minimum 10+ years of regulatory experience
Alternatively, a PhD/PharmD or equivalent with at least 5 years of experience within the biotech or pharmaceutical industry
A minimum of 7 years regulatory experience within the drug development and approval process, specifically in IND/CTAs/Marketing Applications
Experience in interfacing with relevant regulatory authorities
Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
Knowledge and understanding of applicable regulations
Experience in interpretation of regulations, guidelines, policy statements, etc.
Ability to perform research related to regulatory issues
Computer literacy is required
Strong knowledge of global regulatory requirements and guidelines.
Excellent communication and interpersonal skills.
Ability to work collaboratively in cross-functional teams.
Preferred Qualifications
Regulatory Affairs Certification (RAC) is a plus.
How To Apply
If you are a highly motivated Regulatory Affairs Professional looking to make a significant impact in a dynamic and growing company, please submit your resume and a cover letter outlining your relevant experience to .
Hedra Consulting is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences.