Malvern, PA HQ or San Diego, CA
Regulatory Affairs Associate
General Job Description:
The Regulatory Affairs Associate (RA Associate) is responsible for providing support in the planning and preparation of regulatory submissions and the general execution of Regulatory Affairs research support responsibilities.
Interface with project team members and functional departmental representatives to obtain documentation and establish timelines to ensure that complete and accurate submissions are prepared according to plan.
Prepare or assist in the preparation of various regulatory documents.
Plan, compile, and submit regulatory documents for IND and other applications, including initial submissions, amendments, and meeting materials to the FDA or other Regulatory Authorities.
Maintain regulatory databases including submissions and regulatory authority correspondence to meet regulatory compliance requirements.
Participate in the development and review of departmental SOPs.
Review of clinical site regulatory documents intended for site approval and maintenance.
Assist with or execute the electronic publication of documents for submission to the FDA as needed.
BA/BS degree or equivalent experience.
3+ years of Regulatory Affairs/Operations experience in a biotech/pharmaceutical industry
Experience compiling IND, NDA, and other submissions.
Strong attention to detail and the ability to manage multiple tasks.
Ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
Excellent written and communication skills.
Software knowledge of Microsoft Office Suite, Adobe Acrobat, SharePoint required.
Knowledge of eCTD format and regulatory submission requirements desirable.
Experience using or supporting electronic document management systems a plus.
Application Information & Contact (How to Apply)
Please apply on our website career page: https://venatorx.applicantstack.com/x/openings