Regulatory Affairs Associate

October 13, 2018

 

Company Name:

VenatoRx Pharmaceuticals

 

Job Location:

Malvern, PA HQ or San Diego, CA

 

Position Title: 

Regulatory Affairs Associate

 

Position Type:

Full-time 

 

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.

 

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.

 

Qualifications:

  • 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

 

 

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