THE ASSISTANT REGULATORY CONSULTANT
The Assistant Regulatory Consultant is a critical member of the Alira Health project team. The Assistant will work closely with Managers and senior executives and work with clients to guide, write and streamline regulatory projects. The Assistant will help to set direction for clients in the coordination, execution, guidance, and implementation of regulator programs, requirements, and compliance activities. The Assistant will be a key resource for all regulatory activities.
ESSENTIAL JOB FUNCTIONS
• Provide expertise and guidance in interpreting regulations and agency guidelines.
• Provide Regulatory support for processes regarding labeling activities.
• Monitor and analyze the impact of emerging or revised laws, regulations, enforcement actions and other changes that impact the manner by which the clients’ products are regulated around the world.
• Provide, as needed, regulatory strategic support and direction to client programs and initiatives.
• Design and implement regulatory strategies to obtain, maintain and extend product registrations for new biological/pharmaceutical/device product portfolios.
• Oversee the development and submission of regulatory filings to FDA and EU
• Serve as liaison with regulatory agencies.
• Lead core regulatory activities to ensure effective agency interactions that are consistent with clients’ regulatory strategies.
• Provide regulatory guidance and input to clients.
• Provide regulatory operations and electronic submissions support.
• Performs additional duties as assigned.
PREPARATION, KNOWLEDGE, SKILLS & ABILITIES
• BS/BA from a top undergraduate program in a scientific discipline.
• 0 -2 years experience in a regulatory role within pharmaceutical, biotechnology, or medical device sectors.
• Some knowledge of appropriate regulations within your specific sector.
• Some knowledge of FDA, EU MDD/MDR, GCP regulations.
• Strong analytical skills and ability to problem-solve unstructured or ambiguous challenges.
• Demonstrated ability to communicate complex information and analyses to a variety of audiences.
• Strong command of English, both written and verbal.
• Excellent communication and interpersonal skills with client service orientation.
• Advanced skills in MS Office Suite, particularly Word.
• Self-starter who thrives in a collaborative, yet less structured team environment.
• We will not sponsor work visas.
WORKING CONDITIONS/PHYSICAL DEMANDS
Normal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use. Occasional lifting of weight up to 30 lbs.