Regulatory Affairs Senior Specialist

A company is looking for a Regulatory Affairs Senior Specialist.

Key Responsibilities

Manage the preparation and submission of US and Canadian regulatory applications

Provide expertise and innovative solutions on regulatory strategy and processes to clients and internal teams

Maintain knowledge of changing regulatory requirements and liaise with regulatory authorities on behalf of clients

Required Qualifications

Bachelor's Degree with 3-5 years of experience in Regulatory Affairs or equivalent education and experience

Experience in the pharmaceutical industry and understanding of FDA and Canadian Regulatory Affairs procedures

Ability to prioritize and manage multiple projects

Experience with managing and preparing various regulatory submissions, including IND / CTA and NDA / BLA

Ability to maintain confidentiality and adapt to changing conditions